Browsing by Subject "Exercise Therapy"

Now showing 1 - 16 of 16
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    ItemOpen Access
    A Randomized Controlled Trial Investigating the Feasibility and Adherence to an Aerobic Training Program in Healthy Individuals.
    (Journal of sport rehabilitation, 2019-09) Teel, Elizabeth F; Marshall, Stephen W; Appelbaum, L Gregory; Battaglini, Claudio L; Carneiro, Kevin A; Guskiewicz, Kevin M; Register-Mihalik, Johna K; Mihalik, Jason P
    CONTEXT:Concussion management is moving from passive rest strategies to active interventions, including aerobic exercise therapy. Little information is available regarding the feasibility and adherence of these programs. OBJECTIVES:To determine whether an aerobic exercise training program intended for rehabilitation in people with concussion is feasible. Healthy, nonconcussed subjects were studied in this phase 1 trial. DESIGN:Phase 1 parallel-group, randomized controlled trial in a sample of healthy (nonconcussed), recreationally active university students. SETTING:Laboratory. PATIENTS:40 healthy university students. METHODS:Participants were equally randomized to acute concussion therapy intervention (ACTIVE) training or nontraining groups. All participants completed maximal cardiopulmonary exercise tests on a stationary cycle ergometer at 2 test sessions approximately 14 days apart. During this 2-week study period, ACTIVE training participants completed six 30-minute cycling sessions, progressing from 60% to 80% of the participant's individualized maximal oxygen consumption. A subset of participants (NACTIVE = 12, Nnontraining = 11) wore physical activity monitors throughout the 2-week study period. MAIN OUTCOMES MEASURES:Study protocol and randomization effectiveness, exercise safety and adherence, and progressive intensity of the ACTIVE training procedures. RESULTS:No adverse events occurred during any exercise sessions. Twelve ACTIVE training participants (60%) completed all training sessions, and every participant completed at least 4 sessions. Heart rate increased throughout the training period (P < .001), but symptom changes and training adherence remained stable despite the progressively increasing workload. ACTIVE training participants completed approximately 30 additional minutes of physical activity on training sessions days, although that was not statistically significant (P = .20). CONCLUSIONS:University-aged students were adherent to the ACTIVE training protocol. Future research should investigate the safety and feasibility of aerobic training programs in acutely concussed individuals to determine their appropriateness as a clinical rehabilitation strategy.
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    ItemOpen Access
    A systematic review of reviews: exploring the relationship between obesity, weight loss and health-related quality of life.
    (Clinical obesity, 2017-10) Kolotkin, RL; Andersen, JR
    This is the first systematic review of reviews to assess the effect of obesity and weight loss on health-related quality of life (HRQoL). We identified 12 meta-analyses/systematic reviews published between January 2001 and July 2016. They addressed the following themes: (i) the relationship between weight/body mass index and HRQoL (baseline/pre-intervention; n = 2). (ii) HRQoL after weight loss (varied interventions and/or study design; n = 2). (iii) HRQoL after weight loss (randomized controlled trials only; n = 2). (iv) HRQoL after bariatric surgery (n = 6). We found that in all populations, obesity was associated with significantly lower generic and obesity-specific HRQoL. The relationship between weight loss and improved HRQoL was consistently demonstrated after bariatric surgery, perhaps due to a greater than average weight loss compared with other treatments. Improved HRQoL was evident after non-surgical weight loss, but was not consistently demonstrated, even in randomized controlled trials. This inconsistency may be attributed to variation in quality of reporting, assessment measures, study populations and weight-loss interventions. We recommend longer-term studies, using both generic and obesity-specific measures, which go beyond HRQoL in isolation to exploring mediators of HRQoL changes and interactions with other variables, such as comorbidities, fitness level and body image.
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    Aerobic exercise and neurocognitive performance: a meta-analytic review of randomized controlled trials.
    (Psychosom Med, 2010-04) Smith, Patrick J; Blumenthal, James A; Hoffman, Benson M; Cooper, Harris; Strauman, Timothy A; Welsh-Bohmer, Kathleen; Browndyke, Jeffrey N; Sherwood, Andrew
    OBJECTIVES: To assess the effects of aerobic exercise training on neurocognitive performance. Although the effects of exercise on neurocognition have been the subject of several previous reviews and meta-analyses, they have been hampered by methodological shortcomings and are now outdated as a result of the recent publication of several large-scale, randomized, controlled trials (RCTs). METHODS: We conducted a systematic literature review of RCTs examining the association between aerobic exercise training on neurocognitive performance between January 1966 and July 2009. Suitable studies were selected for inclusion according to the following criteria: randomized treatment allocation; mean age > or =18 years of age; duration of treatment >1 month; incorporated aerobic exercise components; supervised exercise training; the presence of a nonaerobic-exercise control group; and sufficient information to derive effect size data. RESULTS: Twenty-nine studies met inclusion criteria and were included in our analyses, representing data from 2049 participants and 234 effect sizes. Individuals randomly assigned to receive aerobic exercise training demonstrated modest improvements in attention and processing speed (g = 0.158; 95% confidence interval [CI]; 0.055-0.260; p = .003), executive function (g = 0.123; 95% CI, 0.021-0.225; p = .018), and memory (g = 0.128; 95% CI, 0.015-0.241; p = .026). CONCLUSIONS: Aerobic exercise training is associated with modest improvements in attention and processing speed, executive function, and memory, although the effects of exercise on working memory are less consistent. Rigorous RCTs are needed with larger samples, appropriate controls, and longer follow-up periods.
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    ItemOpen Access
    Clinical Predictors of Adherence to Exercise Training Among Individuals With Heart Failure: THE HF-ACTION STUDY.
    (Journal of cardiopulmonary rehabilitation and prevention, 2023-05) Collins, Katherine A; Reeves, Gordon R; Miller, Nancy Houston; Whellan, David J; O'Connor, Christopher M; Marcus, Bess H; Kitzman, Dalane W; Kraus, William E; HF-ACTION Investigators

    Purpose

    Suboptimal adherence is a major limitation to achieving the benefits of exercise interventions, and our ability to predict and improve adherence is limited. The purpose of this analysis was to identify baseline clinical and demographic characteristics predicting exercise training adherence in the HF-ACTION study cohort.

    Methods

    Adherence to exercise training, defined by the total duration of exercise performed (min/wk), was evaluated in 1159 participants randomized to the HF-ACTION exercise intervention. More than 50 clinical, demographic, and exercise testing variables were considered in developing a model of the min/wk end point for 1-3 mo (supervised training) and 10-12 mo (home-based training).

    Results

    In the multivariable model for 1-3 mo, younger age, lower income, more severe mitral regurgitation, shorter 6-min walk test distance, lower exercise capacity, and Black or African American race were associated with poorer exercise intervention adherence. No variable accounted for >2% of the variance and the adjusted R2 for the final model was 0.14. Prediction of adherence was similarly limited for 10-12 mo.

    Conclusions

    Clinical and demographic variables available at the initiation of exercise training provide very limited information for identifying patients with heart failure who are at risk for poor adherence to exercise interventions.
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    Group Versus Individual Physical Therapy for Veterans With Knee Osteoarthritis: Randomized Clinical Trial.
    (Physical therapy, 2016-05) Allen, Kelli D; Bongiorni, Dennis; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Lindquist, Jennifer H; Oddone, Eugene Z; Hoenig, Helen

    Background

    Efficient approaches are needed for delivering nonpharmacological interventions for management of knee osteoarthritis (OA).

    Objective

    This trial compared group-based versus individual physical therapy interventions for management of knee OA.

    Design and methods

    Three hundred twenty patients with knee OA at the VA Medical Center in Durham, North Carolina, (mean age=60 years, 88% male, 58% nonwhite) were randomly assigned to receive either the group intervention (group physical therapy; six 1-hour sessions, typically 8 participants per group) or the individual intervention (individual physical therapy; two 1-hour sessions). Both programs included instruction in home exercise, joint protection techniques, and individual physical therapist evaluation. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range=0-96, higher scores indicate worse symptoms), measured at baseline, 12 weeks, and 24 weeks. The secondary outcome measure was the Short Physical Performance Battery (SPPB; range=0-12, higher scores indicate better performance), measured at baseline and 12 weeks. Linear mixed models assessed the difference in WOMAC scores between arms.

    Results

    At 12 weeks, WOMAC scores were 2.7 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% confidence interval [CI]=-5.9, 0.5; P=.10), indicating no between-group difference. At 24 weeks, WOMAC scores were 1.3 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-4.6, 2.0; P=.44), indicating no significant between-group difference. At 12 weeks, SPPB scores were 0.1 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-0.5, 0.2; P=.53), indicating no difference between groups.

    Limitations

    This study was conducted in one VA medical center. Outcome assessors were blinded, but participants and physical therapists were not blinded.

    Conclusions

    Group physical therapy was not more effective than individual physical therapy for primary and secondary study outcomes. Either group physical therapy or individual physical therapy may be a reasonable delivery model for health care systems to consider.
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    Implementation of a group physical therapy program for Veterans with knee osteoarthritis.
    (BMC musculoskeletal disorders, 2020-02) Allen, Kelli D; Sheets, Brandon; Bongiorni, Dennis; Choate, Ashley; Coffman, Cynthia J; Hoenig, Helen; Huffman, Kim; Mahanna, Elizabeth P; Oddone, Eugene Z; Van Houtven, Courtney; Wang, Virginia; Woolson, Sandra; Hastings, Susan N
    BACKGROUND:A previous randomized clinical trial found that a Group Physical Therapy (PT) program for knee osteoarthritis yielded similar improvements in pain and function compared with traditional individual PT. Based on these findings the Group PT program was implemented in a Department of Veterans Affairs Health Care System. The objective of this study was to evaluate implementation metrics and changes in patient-level measures following implementation of the Group PT program. METHODS:This was a one-year prospective observational study. The Group PT program involved 6 weekly sessions. Implementation metrics included numbers of referrals and completed sessions. Patient-level measures were collected at the first and last PT sessions and included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; self-report of pain, stiffness and function (range 0-96)) and a 30-s chair rise test. RESULTS:During the evaluation period, 152 patients were referred, 80 had an initial session scheduled, 71 completed at least one session and 49 completed at least 5 sessions. The mean number of completed appointments per patient was 4.1. Among patients completing baseline and follow-up measures, WOMAC scores (n = 33) improved from 56.8 (SD = 15.8) to 46.9 (SD = 14.0); number of chair rises (n = 38) completed in 30 s increased from 10.4 (SD = 5.1) to 11.9 (SD = 5.0). CONCLUSIONS:Patients completing the Group PT program in this implementation phase showed clinically relevant improvements comparable to those observed in the previous clinical trial that compared group and individual PT for knee osteoarthritis. These results are important because Group PT can improve efficiency and access compared with individual PT. However, there were some limitations with respect to attendance and completion rates, and program adaptations may be needed to optimize these implementation metrics. Larger, longer-term studies are required to more fully evaluate the effectiveness of this program.
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    ItemOpen Access
    Inspiratory Muscle Rehabilitation Training in Pediatrics: What Is the Evidence?
    (Canadian respiratory journal, 2022-01) Bhammar, Dharini M; Jones, Harrison N; Lang, Jason E
    Pulmonary rehabilitation is typically used for reducing respiratory symptoms and improving fitness and quality of life for patients with chronic lung disease. However, it is rarely prescribed and may be underused in pediatric conditions. Pulmonary rehabilitation can include inspiratory muscle training that improves the strength and endurance of the respiratory muscles. The purpose of this narrative review is to summarize the current literature related to inspiratory muscle rehabilitation training (IMRT) in healthy and diseased pediatric populations. This review highlights the different methods of IMRT and their effects on respiratory musculature in children. Available literature demonstrates that IMRT can improve respiratory muscle strength and endurance, perceived dyspnea and exertion, maximum voluntary ventilation, and exercise performance in the pediatric population. These mechanistic changes help explain improvements in symptomology and clinical outcomes with IMRT and highlight our evolving understanding of the role of IMRT in pediatric patients. There remains considerable heterogeneity in the literature related to the type of training utilized, training protocols, duration of the training, use of control versus placebo, and reported outcome measures. There is a need to test and refine different IMRT protocols, conduct larger randomized controlled trials, and include patient-centered clinical outcomes to help improve the evidence base and support the use of IMRT in patient care.
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    ItemOpen Access
    Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.
    (Annals of internal medicine, 2017-03) Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J

    Background

    A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions.

    Objective

    To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes.

    Design

    Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109).

    Setting

    10 Duke University Health System community-based primary care clinics.

    Participants

    537 outpatients with symptomatic hip or knee osteoarthritis.

    Intervention

    The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers.

    Measurements

    The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups.

    Results

    No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care.

    Limitations

    The study involved 1 health care network. Data on provider referrals were not collected.

    Conclusion

    Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care.

    Primary funding source

    National Institute of Arthritis and Musculoskeletal and Skin Diseases.
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    Pragmatic multicentre stepped-wedge cluster randomised trial to investigate the effectiveness of community-based falls prevention programme for older adults with falls risk in Singapore: a protocol paper.
    (BMJ open, 2023-06) Tan, Pey June; Ginting, Mimaika Luluina; Lim, Zoe Zon Be; Balachandar, Nivedha; Sultana, Rehena; Kadir, Mumtaz Mohamed; Xu, Tianma; Ismail, Noor Hafizah; Yap, Joyce Kwee Yong; Wong, Sweet Fun; Yoong, Joanne; Matchar, David Bruce; Hill, Keith; Wong, Chek Hooi

    Introduction

    Falls are an important public health issue with consequences that include injuries, quality of life reduction and high healthcare costs. Studies show that falls prevention strategies are effective in reducing falls rate among community-dwelling older adults. However, the evaluation for effectiveness was usually done in a controlled setting with homogeneous population, and thus may not be generalisable to a wider population. This study aims to evaluate the impact of community falls prevention programmes with group-based strength and balance exercises, on falls risk and health outcomes for older adults with falls risk in Singapore.

    Methods and analysis

    This is a pragmatic closed cohort stepped-wedge cluster randomised trial design study, which involves sequential crossover of clusters from the waitlist control condition to the intervention condition, with the sequence of crossover randomly determined. The intervention will be sequentially rolled out to 12 clusters (a minimum of 5 participants/cluster), over 6 time periods with 8-week intervals in Central and North regions of Singapore. The primary analysis will be conducted under the intention-to-treat principle. A general linear mixed model or generalised estimating equation analysis appropriate for a multilevel longitudinal study incorporating an appropriate error distribution and link function will be used. Markov model will be developed to estimate the incremental cost per quality-adjusted life years and incremental cost per fall prevented from the implementation of falls prevention strategies from a societal perspective. Conditional on there being clinically relevant differences in short-term outcomes, we will implement simulation modelling to project the long-term divergence in trajectories for outcomes and costs using the Markov model.

    Ethics and dissemination

    Ethics approval has been obtained. Results will be disseminated in publications and other relevant platforms.

    Trial registration number

    NCT04788251.
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    PTSD is negatively associated with physical performance and physical function in older overweight military Veterans.
    (Journal of rehabilitation research and development, 2014-01) Hall, Katherine S; Beckham, Jean C; Bosworth, Hayden B; Sloane, Richard; Pieper, Carl F; Morey, Miriam C
    This study examines the effect of posttraumatic stress disorder (PTSD) on function and physical performance in older overweight military Veterans with comorbid conditions. This is a secondary data analysis of older Veterans (mean age = 62.9 yr) participating in a physical activity counseling trial. Study participants with PTSD (n = 67) and without PTSD (n = 235) were identified. Self-reported physical function (36-item Short Form Health Survey) and directly measured physical performance (mobility, aerobic endurance, strength) were assessed. Multivariate analyses of variance controlling for demographic factors and psychiatric disorders demonstrated significant physical impairment among those with PTSD. PTSD was negatively associated with self-reported physical function, functioning in daily activities, and general health (p < 0.01). Those with PTSD also performed significantly worse on tests of lower-limb function (p < 0.05). Despite being significantly younger, Veterans with PTSD had comparable scores on gait speed, aerobic endurance, grip strength, and bodily pain compared with Veterans without PTSD. This study provides preliminary data for the negative association between PTSD and physical function in older military Veterans. These data highlight the importance of ongoing monitoring of physical performance among returning Veterans with PTSD and intervening in older overweight Veterans with PTSD, whose physical performance scores are indicative of accelerated risk of premature functional aging.
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    ItemOpen Access
    Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants.
    (Journal of athletic training, 2018-12-18) Teel, Elizabeth F; Register-Mihalik, Johna K; Appelbaum, Lawrence Gregory; Battaglini, Claudio L; Carneiro, Kevin A; Guskiewicz, Kevin M; Marshall, Stephen W; Mihalik, Jason P
    CONTEXT:Aerobic exercise interventions are increasingly being prescribed for concussion rehabilitation, but whether aerobic training protocols influence clinical concussion diagnosis and management assessments is unknown. OBJECTIVE:To investigate the effects of a brief aerobic exercise intervention on clinical concussion outcomes in healthy, active participants. DESIGN:Randomized controlled clinical trial. SETTING:Laboratory. PATIENTS OR OTHER PARTICIPANTS:Healthy (uninjured) participants (n = 40) who exercised ≥3 times/week. INTERVENTION(S):Participants were randomized into the acute concussion therapy intervention (ACTIVE) training or nontraining group. All participants completed symptom, cognitive, balance, and vision assessments during 2 test sessions approximately 14 days apart. Participants randomized to ACTIVE training completed six 30-minute exercise sessions that progressed from 60% to 80% of individualized maximal oxygen consumption (V˙o2max) across test sessions, while the nontraining group received no intervention. MAIN OUTCOME MEASURE(S):The CNS Vital Signs standardized scores, Vestibular/Ocular Motor Screening near-point convergence distance (cm), and Graded Symptom Checklist, Balance Error Scoring System, and Standardized Assessment of Concussion total scores. RESULTS:An interaction effect was found for total symptom score ( P = .01); the intervention group had improved symptom scores between sessions (session 1: 5.1 ± 5.8; session 2: 1.9 ± 3.6). Cognitive flexibility, executive functioning, reasoning, and total symptom score outcomes were better but composite memory, verbal memory, and near-point convergence distance scores were worse at the second session (all P values < .05). However, few changes exceeded the 80% reliable change indices calculated for this study, and effect sizes were generally small to negligible. CONCLUSIONS:A brief aerobic training protocol had few meaningful effects on clinical concussion assessment in healthy participants, suggesting that current concussion-diagnostic and -assessment tools remain clinically stable in response to aerobic exercise training. This provides normative data for future researchers, who should further evaluate the effect of ACTIVE training on clinical outcomes among concussed populations. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov : NCT02872480.
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    ItemRestricted
    Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer.
    (BMC Cancer, 2010-10-06) Jones, Lee W; Douglas, Pamela S; Eves, Neil D; Marcom, P Kelly; Kraus, William E; Herndon, James E; Inman, Brant A; Allen, Jason D; Peppercorn, Jeffrey
    BACKGROUND: The Exercise Intensity Trial (EXcITe) is a randomized trial to compare the efficacy of supervised moderate-intensity aerobic training to moderate to high-intensity aerobic training, relative to attention control, on aerobic capacity, physiologic mechanisms, patient-reported outcomes, and biomarkers in women with operable breast cancer following the completion of definitive adjuvant therapy. METHODS/DESIGN: Using a single-center, randomized design, 174 postmenopausal women (58 patients/study arm) with histologically confirmed, operable breast cancer presenting to Duke University Medical Center (DUMC) will be enrolled in this trial following completion of primary therapy (including surgery, radiation therapy, and chemotherapy). After baseline assessments, eligible participants will be randomized to one of two supervised aerobic training interventions (moderate-intensity or moderate/high-intensity aerobic training) or an attention-control group (progressive stretching). The aerobic training interventions will include 150 mins.wk⁻¹ of supervised treadmill walking per week at an intensity of 60%-70% (moderate-intensity) or 60% to 100% (moderate to high-intensity) of the individually determined peak oxygen consumption (VO₂peak) between 20-45 minutes/session for 16 weeks. The progressive stretching program will be consistent with the exercise interventions in terms of program length (16 weeks), social interaction (participants will receive one-on-one instruction), and duration (20-45 mins/session). The primary study endpoint is VO₂peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO₂peak, patient-reported outcomes, and biomarkers associated with breast cancer recurrence/mortality. All endpoints will be assessed at baseline and after the intervention (16 weeks). DISCUSSION: EXCITE is designed to investigate the intensity of aerobic training required to induce optimal improvements in VO₂peak and other pertinent outcomes in women who have completed definitive adjuvant therapy for operable breast cancer. Overall, this trial will inform and refine exercise guidelines to optimize recovery in breast and other cancer survivors following the completion of primary cytotoxic therapy. TRIAL REGISTRATION: NCT01186367.
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    Relationships amongst osteoarthritis biomarkers, dynamic knee joint load, and exercise: results from a randomized controlled pilot study.
    (BMC Musculoskelet Disord, 2013-03-27) Hunt, Michael A; Pollock, Courtney L; Kraus, Virginia Byers; Saxne, Tore; Peters, Sue; Peters, Sue; Huebner, Janet L; Sayre, Eric C; Cibere, Jolanda
    BACKGROUND: Little is known about the relationships of circulating levels of biomarkers of cartilage degradation with biomechanical outcomes relevant to knee osteoarthritis (OA) or biomarker changes following non-pharmacological interventions. The objectives of this exploratory, pilot study were to: 1) examine relationships between biomarkers of articular cartilage degradation and synthesis with measures of knee joint load during walking, and 2) examine changes in these biomarkers following 10 weeks of strengthening exercises. METHODS: Seventeen (8 male, 9 female; 66.1 +/- 11.3 years of age) individuals with radiographically-confirmed medial tibiofemoral OA participated. All participants underwent a baseline testing session where serum and urine samples were collected, followed by a three-dimensional motion analysis. Motion analysis was used to calculate the external knee adduction moment (KAM) peak value and impulse. Following baseline testing, participants were randomized to either 10 weeks of: 1) physiotherapist-supervised lower limb muscle strengthening exercises, or 2) no exercises (control). Identical follow-up testing was conducted 11 weeks after baseline. Biomarkers included: urinary C-telopeptide of type II collagen (uCTX-II) and type II collagen cleavage neoepitope (uC2C), serum cartilage oligomeric matrix protein (sCOMP), serum hyaluronic acid (sHA) and serum C-propeptide of type II procollagen (sCPII). Linear regression analysis was used to examine relationships between measures of the KAM and biomarker concentrations as baseline, as well as between-group differences following the intervention. RESULTS: KAM impulse predicted significant variation in uCTX-II levels at baseline (p = 0.04), though not when controlling for disease severity and walking speed (p = 0.33). KAM impulse explained significant variation in the ratio uCTX-II;sCPII even when controlling for additional variables (p = 0.04). Following the intervention, changes in sCOMP were significantly greater in the exercise group compared to controls (p = 0.04). On average those in the control group experienced a slight increase in sCOMP and uCTX-II, while those in the exercise group experienced a reduction. No other significant findings were observed. CONCLUSIONS: This research provides initial evidence of a potential relationship between uCTX-II and knee joint load measures in patients with medial tibiofemoral knee OA. However, this relationship became non-significant after controlling for disease severity and walking speed, suggesting further research is necessary. It also appears that sCOMP is amenable to change following a strengthening intervention, suggesting a potential beneficial role of exercise on cartilage structure. TRIAL REGISTRATION: Clinicaltrials.gov NCT01241812.
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    STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial.
    (BMC musculoskeletal disorders, 2019-05) Allen, Kelli D; Bongiorni, Dennis; Caves, Kevin; Coffman, Cynthia J; Floegel, Theresa A; Greysen, Heather M; Hall, Katherine S; Heiderscheit, Bryan; Hoenig, Helen M; Huffman, Kim M; Morey, Miriam C; Ramasunder, Shalini; Severson, Herbert; Smith, Battista; Van Houtven, Courtney; Woolson, Sandra

    Background

    Physical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.

    Methods / design

    Step-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.

    Discussion

    STEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.

    Trial registration

    Clinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.
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    The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design.
    (BMC Cancer, 2010-04-21) Jones, Lee W; Eves, Neil D; Kraus, William E; Potti, Anil; Crawford, Jeffrey; Blumenthal, James A; Peterson, Bercedis L; Douglas, Pamela S
    BACKGROUND: The Lung Cancer Exercise Training Study (LUNGEVITY) is a randomized trial to investigate the efficacy of different types of exercise training on cardiorespiratory fitness (VO2peak), patient-reported outcomes, and the organ components that govern VO2peak in post-operative non-small cell lung cancer (NSCLC) patients. METHODS/DESIGN: Using a single-center, randomized design, 160 subjects (40 patients/study arm) with histologically confirmed stage I-IIIA NSCLC following curative-intent complete surgical resection at Duke University Medical Center (DUMC) will be potentially eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of four conditions: (1) aerobic training alone, (2) resistance training alone, (3) the combination of aerobic and resistance training, or (4) attention-control (progressive stretching). The ultimate goal for all exercise training groups will be 3 supervised exercise sessions per week an intensity above 70% of the individually determined VO2peak for aerobic training and an intensity between 60 and 80% of one-repetition maximum for resistance training, for 30-45 minutes/session. Progressive stretching will be matched to the exercise groups in terms of program length (i.e., 16 weeks), social interaction (participants will receive one-on-one instruction), and duration (30-45 mins/session). The primary study endpoint is VO2peak. Secondary endpoints include: patient-reported outcomes (PROs) (e.g., quality of life, fatigue, depression, etc.) and organ components of the oxygen cascade (i.e., pulmonary function, cardiac function, skeletal muscle function). All endpoints will be assessed at baseline and postintervention (16 weeks). Substudies will include genetic studies regarding individual responses to an exercise stimulus, theoretical determinants of exercise adherence, examination of the psychological mediators of the exercise - PRO relationship, and exercise-induced changes in gene expression. DISCUSSION: VO2peak is becoming increasingly recognized as an outcome of major importance in NSCLC. LUNGEVITY will identify the optimal form of exercise training for NSCLC survivors as well as provide insight into the physiological mechanisms underlying this effect. Overall, this study will contribute to the establishment of clinical exercise therapy rehabilitation guidelines for patients across the entire NSCLC continuum. TRIAL REGISTRATION: NCT00018255.
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    Warrior Wellness: A Randomized Controlled Pilot Trial of the Effects of Exercise on Physical Function and Clinical Health Risk Factors in Older Military Veterans With PTSD.
    (The journals of gerontology. Series A, Biological sciences and medical sciences, 2020-10) Hall, Katherine S; Morey, Miriam C; Beckham, Jean C; Bosworth, Hayden B; Sloane, Richard; Pieper, Carl F; Pebole, Michelle M

    Background

    Military veterans living with post-traumatic stress disorder (PTSD) face significant physical and functional health disparities, which are often aggravated over time and in the context aging. Evidence has shown that physical activity can positively impact age-related health conditions, yet exercise trials in older adults with mental disorders are rare. Our study was a tailored and targeted pilot exercise intervention for older veterans with PTSD.

    Methods

    Fifty-four older veterans with PTSD (mean age = 67.4 years, 90.7% male, 85.2% non-white) were randomized to supervised exercise (n = 38) or wait-list usual care (n = 18) for 12 weeks. Physical activity (MET-min/wk) and aerobic endurance (assessed with the 6-minute walk test) were primary outcomes. Secondary outcomes were physical performance (strength, mobility, balance), cardiometabolic risk factors (eg, waist circumference), and health-related quality of life.

    Results

    At 12 weeks, a large effect of the intervention on physical activity levels (Cohen's d = 1.37) was observed compared to wait-list usual care. Aerobic endurance improved by 69 m in the exercise group compared to 10 m in wait-list group, reflecting a moderate between-group effect (Cohen's d = 0.50). Between-group differences on 12-week changes in physical performance, cardiometabolic risk factors, and health-related quality of life ranged from small to large effects (Cohen's d = 0.28-1.48), favoring the exercise arm.

    Conclusion

    Participation in supervised exercise improved aerobic endurance, physical performance, and health-related clinical factors in older veterans with PTSD; a medically complex population with multiple morbidity. Group exercise is a low-cost, low-stigma intervention, and implementation efforts among older veterans with PTSD warrants further consideration.