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Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial.

ABSTRACT: Effective treatment of locomotor dysfunction in Parkinson disease (PD) is essential, as gait difficulty is an early and major contributor to disability. Exercise is recommended as an adjunct to traditional treatments for improving gait, balance, and quality of life. Among the exercise approaches known to improve walking, tango and treadmill training have recently emerged as two promising therapies for improving gait, disease severity and quality of life, yet these two interventions have not been directly compared to each other. Prior studies have been helpful in identifying interventions effective in improving gait function, but have done little to elucidate the neural mechanisms underlying functional improvements. The primary objective of the proposed work is to compare the effects of three community-based exercise programs, tango, treadmill training and stretching, on locomotor function in individuals with PD. In addition, we aim to determine whether and how these interventions alter functional connectivity of locomotor control networks in the brain.One hundred and twenty right-handed individuals with idiopathic PD who are at least 30 years of age will be assigned in successive waves to one of three community-based exercise groups: tango dancing, treadmill training or stretching (control). Each group will receive three months of exercise training with twice weekly one-hour group classes. Each participant will be evaluated at three time points: pre-intervention (baseline), post-intervention (3 months), and follow-up (6 months). All evaluations will include assessment of gait, balance, disease severity, and quality of life. Baseline and post-intervention evaluations will also include task-based functional magnetic resonance imaging (fMRI) and resting state functional connectivity MRI. All MRI and behavioral measures will be conducted with participants OFF anti-Parkinson medication, with behavioral measures also assessed ON medication.This study will provide important insights regarding the effects of different modes of exercise on locomotor function in PD. The protocol is innovative because it: 1) uses group exercise approaches for all conditions including treadmill training, 2) directly compares tango to treadmill training and stretching, 3) tests participants OFF medication, and 4) utilizes two distinct neuroimaging approaches to explore mechanisms of the effects of exercise on the brain.ClinicalTrials.gov NCT01768832 .

SUBMITTER: Earhart GM

PROVIDER: S-EPMC4326476 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial.

Earhart Gammon M GM Duncan Ryan P RP Huang John L JL Perlmutter Joel S JS Pickett Kristen A KA

BMC neurology 20150205

<h4>Background</h4>Effective treatment of locomotor dysfunction in Parkinson disease (PD) is essential, as gait difficulty is an early and major contributor to disability. Exercise is recommended as an adjunct to traditional treatments for improving gait, balance, and quality of life. Among the exercise approaches known to improve walking, tango and treadmill training have recently emerged as two promising therapies for improving gait, disease severity and quality of life, yet these two interven ...[more]

PMID: 25652002

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Project description:ObjectiveTo determine whether falls can be prevented with minimally supervised exercise targeting potentially remediable fall risk factors, i.e., poor balance, reduced leg muscle strength, and freezing of gait, in people with Parkinson disease.MethodsTwo hundred thirty-one people with Parkinson disease were randomized into exercise or usual-care control groups. Exercises were practiced for 40 to 60 minutes, 3 times weekly for 6 months. Primary outcomes were fall rates and proportion of fallers during the intervention period. Secondary outcomes were physical (balance, mobility, freezing of gait, habitual physical activity), psychological (fear of falling, affect), and quality-of-life measures.ResultsThere was no significant difference between groups in the rate of falls (incidence rate ratio [IRR] = 0.73, 95% confidence interval [CI] 0.45-1.17, p = 0.18) or proportion of fallers (p = 0.45). Preplanned subgroup analysis revealed a significant interaction for disease severity (p < 0.001). In the lower disease severity subgroup, there were fewer falls in the exercise group compared with controls (IRR = 0.31, 95% CI 0.15-0.62, p < 0.001), while in the higher disease severity subgroup, there was a trend toward more falls in the exercise group (IRR = 1.61, 95% CI 0.86-3.03, p = 0.13). Postintervention, the exercise group scored significantly (p < 0.05) better than controls on the Short Physical Performance Battery, sit-to-stand, fear of falling, affect, and quality of life, after adjusting for baseline performance.ConclusionsAn exercise program targeting balance, leg strength, and freezing of gait did not reduce falls but improved physical and psychological health. Falls were reduced in people with milder disease but not in those with more severe Parkinson disease.Classification of evidenceThis study provides Class III evidence that for patients with Parkinson disease, a minimally supervised exercise program does not reduce fall risk. This study lacked the precision to exclude a moderate reduction or modest increase in fall risk from exercise.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12608000303347).

Project description:BackgroundBoth manual therapy techniques and dry needling have shown to be effective treatment options for the treatment of plantar heel pain; however, in recent years, other techniques based on dry needling (DN), such as percutaneous needle electrolysis (PNE), have also emerged. Currently, PNE is being used in clinical practice to manage myofascial trigger points, despite the lack of studies comparing the effects of this technique over dry needling. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for improving the level of pain experienced by patients suffering from plantar heel pain provoked by myofascial trigger points.MethodsA randomized controlled trial will be conducted with blinded participants and outcome assessors. A sample of 94 patients with a medical diagnosis of plantar heel pain will be recruited and divided into two treatment groups. Eligible participants will be randomly allocated to either (a) treatment group with DN and a self-stretching home program or (b) treatment group with PNE and a self-stretching home program. Each group will receive one treatment session per week over a period of 4 weeks. The primary outcome measure will be the pain subscale of the Foot Health Status Questionnaire. The secondary outcome measures will be a visual analogue scale for pain (average and highest level of pain experienced during the previous 48 h; level of pain immediately after the treatment session) and health-related quality of life (assessed using the EuroQoL-5 dimensions). Cost-effectiveness data will be extracted based on the EuroQoL-5 dimensions. Follow-up measurements will take place at baseline and at 4, 8, 12, 26, and 52 weeks.DiscussionThe justification for this trial is the need to improve current understanding regarding the effectiveness of treatments targeting the rehabilitation of plantar heel pain. This study will be the first randomized controlled trial to directly compare the effectiveness of DN and PNE combined with a specific stretching program for the treatment of plantar heel pain provoked by myofascial trigger points.Trial registrationClinical Trials NCT03236779. Registered at clinicaltrials.gov 2 August 2017.

Project description:BackgroundCancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that persists for years after treatment completion in approximately one third of cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. There are multiple potential pathways by which exercise improves CRF, and cancer survivors with CRF are diverse with respect to cancer type, treatments and experienced side effects. While the general exercise guidelines are likely sufficient for most cancer survivors, tailoring of exercise interventions may be more effective in those with persistent fatigue. The primary aim of this research is to investigate the effect of a traditional vs. tailored exercise intervention on CRF severity in cancer survivors with persistent CRF.Methods/designCancer survivors (≥ 3 months and ≤ 5 years since primary treatment) who score ≤ 34 on the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) will be randomly allocated to one of two parallel treatment arms: traditional (active control) and tailored exercise. Participants in the traditional exercise group will engage in aerobic and resistance exercise that is consistent with exercise guidelines for cancer survivors. The tailored exercise group will be prescribed an intervention designed to address individual deficits identified at baseline, such as loss of muscular strength, cardiorespiratory deconditioning or sleep disturbance. Participants will be assessed before and after the intervention for CRF severity and other patient-reported outcomes, neuromuscular function and fatigue in response to whole-body exercise, sleep quantity and quality, physical activity levels, cardiorespiratory fitness and blood biomarkers.DiscussionTo our knowledge, this will be the first study to compare the effects of a traditional vs. tailored exercise intervention on CRF severity in cancer survivors with persistent CRF. Using physiological, behavioural and patient-reported outcomes, this study will add to the current knowledge about both the factors contributing to CRF, and the potential reduction in CRF severity with an exercise intervention.Trial registrationThe study is registered at ClinicalTrials.gov ( NCT03049384 ), February, 2017.

Project description:BACKGROUND:Weight loss induced only by exercise is frequently less than expected, possibly because of compensatory changes in energy intake and/or energy expenditure. The purpose of the Examination of Mechanisms (E-MECHANIC) of Exercise-Induced Weight Compensation trial is to examine whether increased energy intake and/or reduced spontaneous activity or energy expenditure (outside of structured exercise) account for the less than expected, exercise-associated weight loss. METHODS/DESIGN:E-MECHANIC is a three-arm, 6-month randomized (1:1:1) controlled trial. The two intervention arms are exercise doses that reflect current recommendations for (1) general health (8 kcal/kg body weight per week (8 KKW), about 900 kcal/wk) and (2) weight loss (20 KKW, about 2,250 kcal/wk). The third arm, a nonexercise control group, will receive health information only. The sample will include a combined total of 198sedentary, overweight or obese (body mass index: ?25 kg/m² to ?45 kg/m²) men and women ages 18 to 65 years. The exercise dose will be supervised and tightly controlled in an exercise training laboratory. The primary outcome variables are energy intake, which will be measured using doubly labeled water (adjusted for change in energy stores) and laboratory-based food intake tests, and the discrepancy between expected weight loss and observed weight loss. Secondary outcomes include changes in resting metabolic rate (adjusted for change in body mass), activity levels (excluding structured exercise) and body composition. In an effort to guide the development of future interventions, the participants will be behaviorally phenotyped and defined as those who do compensate (that is, fail to lose the amount of weight expected) or do not compensate (that is, lose the amount of weight expected or more). DISCUSSION:In this study, we will attempt to identify underlying mechanisms to explain why exercise elicits less weight loss than expected. This information will guide the development of interventions to increase exercise-induced weight loss and maximize weight loss retention and related health benefits. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT01264406 (registration date: 20 December 2010).

Project description:Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden.We are conducting a randomized comparative effectiveness study (Connect.Parkinson) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist. Recruitment is completed centrally using online advertisements and emails and by contacting physicians, support groups, and allied health professionals. Efforts target areas with a high proportion of individuals not receiving care from neurologists. Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year. Participants receive educational materials, then are randomized in a 1:1 ratio to continue their usual care (control arm) or usual care and specialty care delivered virtually (intervention arm). Care partners are surveyed about their time and travel burden and their perceived caregiver burden. Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months. All study activities are completed remotely.The primary outcomes are: (1) feasibility, as measured by the proportion of visits completed, and (2) quality of life, as measured by the 39-item Parkinson's Disease Questionnaire. Secondary outcomes include measures of clinical benefit, quality of care, time and travel burden, and caregiver burden.Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease. The trial may serve as a model for increasing access and delivering patient-centered care at home for individuals with chronic conditions.This trial was registered on clinicaltrials.gov on January 8, 2014 [NCT02038959].

Project description:BackgroundExercise confers short-term benefits for individuals with Parkinson disease (PD).ObjectiveThe purpose of the study was to compare short- and long-term responses among 2 supervised exercise programs and a home-based control exercise program.DesignThe 16-month randomized controlled exercise intervention investigated 3 exercise approaches: flexibility/balance/function exercise (FBF), supervised aerobic exercise (AE), and home-based exercise (control).SettingThis study was conducted in outpatient clinics.PatientsThe participants were 121 individuals with PD (Hoehn & Yahr stages 1-3).InterventionsThe FBF program (individualized spinal and extremity flexibility exercises followed by group balance/functional training) was supervised by a physical therapist. The AE program (using a treadmill, bike, or elliptical trainer) was supervised by an exercise trainer. Supervision was provided 3 days per week for 4 months, and then monthly (16 months total). The control group participants exercised at home using the National Parkinson Foundation Fitness Counts program, with 1 supervised, clinic-based group session per month.MeasurementsOutcomes, obtained by blinded assessors, were determined at 4, 10, and 16 months. The primary outcome measures were overall physical function (Continuous Scale-Physical Functional Performance [CS-PFP]), balance (Functional Reach Test [FRT]), and walking economy (oxygen uptake [mL/kg/min]). Secondary outcome measures were symptom severity (Unified Parkinson's Disease Rating Scale [UPDRS] activities of daily living [ADL] and motor subscales) and quality of life (39-item Parkinson's Disease Quality of Life Scale [PDQ-39]).ResultsOf the 121 participants, 86.8%, 82.6%, and 79.3% completed 4, 10, and 16 months, respectively, of the intervention. At 4 months, improvement in CS-PFP scores was greater in the FBF group than in the control group (mean difference=4.3, 95% confidence interval [CI]=1.2 to 7.3) and the AE group (mean difference=3.1, 95% CI=0.0 to 6.2). Balance was not different among groups at any time point. Walking economy improved in the AE group compared with the FBF group at 4 months (mean difference=-1.2, 95% CI=-1.9 to -0.5), 10 months (mean difference=-1.2, 95% CI=-1.9 to -0.5), and 16 months (mean difference=-1.7, 95% CI=-2.5 to -1.0). The only secondary outcome that showed significant differences was UPDRS ADL subscale scores: the FBF group performed better than the control group at 4 months (mean difference=-1.47, 95% CI=-2.79 to -0.15) and 16 months (mean difference=-1.95, 95% CI=-3.84 to -0.08).LimitationsAbsence of a non-exercise control group was a limitation of the study.ConclusionsFindings demonstrated overall functional benefits at 4 months in the FBF group and improved walking economy (up to 16 months) in the AE group.

Project description:INTRODUCTION:Despite increasing evidence that aerobic exercise and cognitive training improve cognitive function among patients with cognitive impairment and dementia, few studies have focused on the effect of a combination of these approaches. This study will explore whether combining aerobic training (AT) with mindfulness training (MT), an intervention promoting the moment-to-moment awareness of physical sensations, affective states, and thoughts, improves cognitive function in individuals at risk of dementia. The primary objective is to determine the feasibility and acceptability of the intervention(s). The secondary objective is to obtain estimates of effect sizes on cognitive function and on possible mediators. METHODS AND ANALYSIS:Forty participants with at least 2 risk factors for dementia will be randomized (2?×?2 factorial design) to either AT (3?sessions/week for 12 weeks), MT (1?session/week for 8 weeks), both, or usual care. Assessments of cognitive function (attention, executive function, episodic, and working memory); physical activity (accelerometry), aerobic capacity (6-minute walk test), waist-to-hip ratio, blood pressure, social support (Multidimensional Scale of Perceived Social Support), depression (Hospital Anxiety and Depression Scale), and mindfulness (Five Facets of Mindfulness) will be conducted at baseline, end of treatment, and 6-months postbaseline. Rates of retention, attendance, and program satisfaction will be calculated for each of the 4 groups to determine the feasibility and acceptability of each intervention. ETHICS AND DISSEMINATION:This study has full ethical approval by The Miriam Hospital Institutional Review Board and adheres to the Standard Protocol Items: Recommendations for Interventional Trials reporting recommendations. If results from this exploratory, proof-of-concept study support our hypotheses, we will conduct a large randomized controlled trial (RCT) to determine the efficacy of combined MT and AT in improving cognitive function in individuals at risk of dementia. Results from the study will be disseminated through peer-reviewed journals and conference presentations. REGISTRATION DETAILS:: http://www.clinicalstrials.gov identifier NCT03289546.

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Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial.

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Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial.

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