Impact of Exercise in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: Sleep hygiene; Other: Exercise training

• Registration Number: NCT03495193
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The goal of this research is to identify an intervention that will improve cognition and sleep in persons with PD.

Detailed Description

Persons with Parkinson's disease (PD) often experience non-motor symptoms such as cognitive dysfunction and sleep problems. These symptoms can be more disabling than the motor symptoms of PD. Medications are often not effective for treating these non-motor symptoms or can have unwanted side effects. Non- medication treatments such as exercise are known to improve the motor symptoms of PD, but the effect of exercise on cognition and sleep has not been fully explored. This study investigates the impact of 16 weeks of supervised exercise, 3 times per week, compared to no-exercise over the same duration, on cognition and sleep dysfunction. Participants will be evaluated with cognitive tests and sleep studies before and after 16-weeks to determine the impact of this exercise intervention. The goal of this research is to identify an intervention that will improve cognition and sleep in persons with PD.

Study Timeline

• Study Start: 2017-05-18
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• a clinical diagnosis of idiopathic PD, based on the presence of bradykinesia as well as rest tremor and/or rigidity;
• Hoehn and Yahr stage 2-3;
• age ≥ 45;
• on stable medications for at least 4 weeks prior to study entry;
• Participants must have Montreal Cognitive Assessment (MoCA) score ≥ 18;
• No contraindications to an exercise program, based on the Physical Activity Readiness Questionnaire (PAR-Q), resting physical examination, and 12-lead electrocardiogram.

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Exclusion Criteria

• features suggestive of atypical Parkinsonism (cerebellar signs, supranuclear gaze palsy, prominent autonomic failure, or prominent upper motor neuron signs);
• secondary Parkinsonism (multiple strokes with stepwise progression of Parkinsonism, neuroleptic treatment at time of diagnosis, or multiple head injuries);
• inability to walk without a cane or walker;
• regular participation in an exercise program in the past 6 months;
• presence of deep brain stimulator; and
• untreated sleep apnea.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Exercise Group	Sleep hygiene	Subjects randomized to the no-Ex group will receive a handout with tips for improving sleep hygiene. Additionally, study staff will provide the title page for a book on sleep relaxation techniques that is recommended for persons with sleeping difficulty.
Exercise Group	Exercise training	Subjects randomized to the exercise training group will complete 16 weeks of exercise training. Exercise training will be performed 3x/week.

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency	changes from baseline and week 16	Change in sleep efficiency (the number of minutes asleep divided by the number of minutes in bed) between the baseline nocturnal polysomnography to the post-16 weeks of intervention nocturnal polysomnography
Executive function (Stroop inhibition, Trails B-A, Controlled oral word association)	changes from baseline to week 16	Changes in executive function will be measured by a change in a composite executive function score calculated from the mean of z-scores for Stroop inhibition, Trails B-A, and COWA.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States