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Exercise and medication effects on persons with Parkinson disease across the domains of disability: a randomized clinical trial.

ABSTRACT: Hypokinesia and bradykinesia as movement deficits of Parkinson disease are thought to be mediated by both basal ganglia dysfunction and a loss of muscle mass and strength commensurate with aging and decreased levels of physical activity. For these reasons, we sought to utilize resistance training as a means to increase muscle force and minimize hypokinesia and bradykinesia in persons with Parkinson disease and examine the effects of exercise and medication on Body Structure and Function (muscle force production and muscle cross-sectional area), Activity (mobility), and Participation (Health Status) outcomes.Forty-two participants were enrolled in a 12-week randomized clinical trial that compared 2 active exercise interventions: a standard care control group (Active Control) and an experimental group that underwent Resistance Exercise via Negative Eccentric Work (RENEW).Participants in both groups improved in muscle force production and mobility as a result of exercise and medication (P < 0.02). There were no significant interaction or between-group differences and no significant changes in muscle cross-sectional area or health status were observed. Effect sizes for exercise and medication combined exceeded the effect sizes of either intervention in isolation.Taken together, these results point to the complementary effects of exercise and medication on the Body Structure and Function and Activity outcomes but little effect on Participation outcomes.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A92).

SUBMITTER: Dibble LE

PROVIDER: S-EPMC4366306 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Exercise and medication effects on persons with Parkinson disease across the domains of disability: a randomized clinical trial.

Dibble Leland E LE Foreman K Bo KB Addison Odessa O Marcus Robin L RL LaStayo Paul C PC

Journal of neurologic physical therapy : JNPT 20150401 2

<h4>Background and purpose</h4>Hypokinesia and bradykinesia as movement deficits of Parkinson disease are thought to be mediated by both basal ganglia dysfunction and a loss of muscle mass and strength commensurate with aging and decreased levels of physical activity. For these reasons, we sought to utilize resistance training as a means to increase muscle force and minimize hypokinesia and bradykinesia in persons with Parkinson disease and examine the effects of exercise and medication on Body ...[more]

PMID: 25742370

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Project description:To compare the efficacy of treadmill exercises and stretching and resistance exercises in improving gait speed, strength, and fitness for patients with Parkinson disease.A comparative, prospective, randomized, single-blinded clinical trial of 3 types of physical exercise.The Parkinson's Disease and Movement Disorders Center at the University of Maryland and the Baltimore Veterans Affairs Medical Center, Geriatric Research Education and Clinical Center.A total of 67 patients with Parkinson disease who had gait impairment were randomly assigned to 1 of 3 arms of the trial. INTERVENTIONS; (1) A higher-intensity treadmill exercise (30 minutes at 70%-80% of heart rate reserve), (2) a lower-intensity treadmill exercise (50 minutes at 40%-50% of heart rate reserve), and (3) stretching and resistance exercises (2 sets of 10 repetitions on each leg on 3 resistance machines [leg press, leg extension, and curl]). These exercises were performed 3 times a week for 3 months.The primary outcome measures were gait speed (6-minute walk), cardiovascular fitness (peak oxygen consumption per unit time [$$ VO2], and muscle strength (1-repetition maximum strength).All 3 types of physical exercise improved distance on the 6-minute walk: lower-intensity treadmill exercise (12% increase; P=.001), stretching and resistance exercises (9% increase; P<.02), and higher-intensity treadmill exercise (6% increase; P=.07), with no between-group differences. Both treadmill exercises improved peak $$ VO2 (7%-8% increase; P<.05) more than did the stretching and resistance exercises. Only stretching and resistance improved muscle strength (16% increase; P<.001).The effects of exercise were seen across all 3 exercise groups. The lower-intensity treadmill exercise resulted in the greatest improvement in gait speed. Both the higher- and lower-intensity treadmill exercises improved cardiovascular fitness. Only the stretching and resistance exercises improved muscle strength. Therefore, exercise can improve gait speed, muscle strength, and fitness for patients with Parkinson disease. The combination of treadmill and resistance exercises may result in greater benefit and requires further investigation.

Project description:INTRODUCTION:Recruitment of sufficient patients with Parkinson disease into clinical trials is a barrier to successful, timely study completion. Non-pharmacologic studies have shown to be even more challenging for recruitment, despite some studies focusing on de novo Parkinson disease populations. This paper describes successful recruitment techniques from a randomized exercise clinical trial in Parkinson disease. METHODS:Several recruitment strategies were used to enroll de novo patients with Parkinson disease into a year-long clinical trial. Strategies focused on infrastructure included fast-track clinic scheduling, weekly research meetings, an established clinical repository, real-time clinic recruitment, and outreach to the community. The nature of the study facilitated recruitment by offering a wait-listed control group, exercise at a local fitness center with a paid membership, and collection of data by shipping equipment foregoing some visits. An experienced nurse study coordinator involved in recruitment and training of the principal investigator in recruitment of minorities enhanced overall recruitment. Finally, the patient population chosen for this study, patients with de novo Parkinson disease, may be more likely to enroll in an exercise study than patients with later stage disease. RESULTS:Seventy-six patients with de novo Parkinson disease were successfully enrolled into the exercise clinical trial from a single site. CONCLUSION:Targeted recruitment strategies were successful in this study. Additional modifications to the study protocol, such as eliminating treadmill stress tests before randomization, travel to an urban downtown location for study visits, and a relatively healthy Parkinson disease population, may also have impacted this study. These strategies could all be adopted for other studies in Parkinson disease, neurodegenerative diseases, or other chronic disorders. TRIAL REGISTRATION:Clinicaltrials.gov, NCT01506479 . Registered on 10 January 2012.

Project description:Background: Improving balance-related ability is an important goal in stroke rehabilitation. Evidence is needed to demonstrate how this goal could be better achieved. Aim: Determine if trunk exercises on unstable surfaces would improve trunk control and balance for persons in the subacute stage of stroke. Design: An assessor-blind randomized controlled trial. Setting: Inpatients in the department of rehabilitation in a general hospital. Population: Patients who suffered a first-time stroke with onset from one to six months. Methods: Inpatients with stroke were assigned to upper limb exercises (control group, n = 17) or trunk exercises on unstable surfaces (experimental group, n = 18) to receive training twice a week for six weeks, in addition to their daily conventional stroke rehabilitation. Sensorimotor function tests, including hand grip, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale, and clinical outcome assessments, including Trunk Impairment Scale and 6 m walk test, were conducted before and after six weeks of training. The center of the pressure area while maintaining static posture and peak displacement while leaning forward, as well as the average speed of raising the unaffected arm, were measured in sitting without foot support, sitting with foot support and standing to reflect trunk control, sitting balance and standing balance, respectively. Results: The between-group differences in the sensorimotor functions were nonsignificant before and after training. Compared with the control group, the experimental group had significantly greater forward leaning and faster arm raising in sitting without foot support, higher Trunk Impairment Scale total score, and shorter 6 m walking time after training, but not before training. Conclusion: Trunk exercises on unstable surfaces could further improve trunk control, the ability to raise the unaffected arm rapidly in sitting, and walking for persons in the subacute stage of stroke. This intervention may be considered to be included in stroke rehabilitation.

Project description:To 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.Two 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.There 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.An 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.This 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.Australian New Zealand Clinical Trials Registry (ACTRN12608000303347).

Project description:Importance:Clinical trials have confirmed the efficacy of focused ultrasound (FUS) thalamotomy in essential tremor, but its effectiveness and safety for managing tremor-dominant Parkinson disease (TDPD) is unknown. Objective:To assess safety and efficacy at 12-month follow-up, accounting for placebo response, of unilateral FUS thalamotomy for patients with TDPD. Design, Setting, and Participants:Of the 326 patients identified from an in-house database, 53 patients consented to be screened. Twenty-six were ineligible, and 27 were randomized (2:1) to FUS thalamotomy or a sham procedure at 2 centers from October18, 2012, to January 8, 2015. The most common reasons for disqualification were withdrawal (8 persons [31%]), and not being medication refractory (8 persons [31%]). Data were analyzed using intention-to-treat analysis, and assessments were double-blinded through the primary outcome. Interventions:Twenty patients were randomized to unilateral FUS thalamotomy, and 7 to sham procedure. The sham group was offered open-label treatment after unblinding. Main Outcomes and Measures:The predefined primary outcomes were safety and difference in improvement between groups at 3 months in the on-medication treated hand tremor subscore from the Clinical Rating Scale for Tremor (CRST). Secondary outcomes included descriptive results of Unified Parkinson's Disease Rating Scale (UPDRS) scores and quality of life measures. Results:Of the 27 patients, 26 (96%) were male and the median age was 67.8 years (interquartile range [IQR], 62.1-73.8 years). On-medication median tremor scores improved 62% (IQR, 22%-79%) from a baseline of 17 points (IQR, 10.5-27.5) following FUS thalamotomy and 22% (IQR, -11% to 29%) from a baseline of 23 points (IQR, 14.0-27.0) after sham procedures; the between-group difference was significant (Wilcoxon P?=?.04). On-medication median UPDRS motor scores improved 8 points (IQR, 0.5-11.0) from a baseline of 23 points (IQR, 15.5-34.0) following FUS thalamotomy and 1 point (IQR, -5.0 to 9.0) from a baseline of 25 points (IQR, 15.0-33.0) after sham procedures. Early in the study, heating of the internal capsule resulted in 2 cases (8%) of mild hemiparesis, which improved and prompted monitoring of an additional axis during magnetic resonance thermometry. Other persistent adverse events were orofacial paresthesia (4 events [20%]), finger paresthesia (1 event [5%]), and ataxia (1 event [5%]). Conclusions and Relevance:Focused ultrasound thalamotomy for patients with TDPD demonstrated improvements in medication-refractory tremor by CRST assessments, even in the setting of a placebo response. Trial Registration:ClinicalTrials.gov identifier NCT01772693.

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Exercise and medication effects on persons with Parkinson disease across the domains of disability: a randomized clinical trial.

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Exercise and medication effects on persons with Parkinson disease across the domains of disability: a randomized clinical trial.

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