Impact of Exercise in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT03495193
• Recruitment Status: Completed
• First Posted: April 11, 2018
• Last Update Posted: April 26, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborator: Parkinson's Disease Foundation
• Information provided by (Responsible Party): Amy Amara, MD, University of Alabama at Birmingham

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Other: Exercise training; Behavioral: Sleep hygiene	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The proposed study is a randomized, controlled, interventional study to investigate the impact of a novel exercise intervention on executive dysfunction (Aim 1) and objective sleep outcomes (Aim 2) in patients with PD. Thirty participants with idiopathic PD will be recruited from the University of Alabama at Birmingham (UAB) Movement Disorders Center and randomized (1:1) to one of two groups (15 per group): exercise intervention (Ex) group or no-exercise (no-Ex) control group.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of a Novel Exercise Intervention on Executive Function and Sleep in Patients With Parkinson's Disease
• Actual Study Start Date: May 18, 2017
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: November 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Exercise Group; Subjects randomized to the exercise training group will complete 16 weeks of exercise training. Exercise training will be performed 3x/week.	Other: Exercise training; Exercise training will be performed 3x/week. After 2 sessions, training volume and intensity will progress over the first 4 sessions ramping up the number of sets to increase the volume. The full volume prescription will consist of: 1) 5 movements to improve strength and muscle mass (leg press, knee extension, chest press, overhead press, pull down), 3 sets each of 8-12 repetitions (~30 total repetitions); 2) trunk exercises to improve postural stability (trunk extension and flexion); 3) 3-4 bodyweight exercises (selected from a menu) to improve power and balance (e.g. step up, squat, jump squat, lunge, side lunge, push-up, assisted pull-up, assisted dip). Bodyweight movements will be modified as necessary to match abilities.
Active Comparator: No Exercise Group; 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.	Behavioral: Sleep hygiene; Subjects randomized to the no-exercise group will receive a handout with tips for improving sleep. Additionally, study staff will provide the title page for a book on sleep relaxation techniques that is recommended for persons with sleeping difficulty. Dr. Amara will review the sleep tips with the subjects and make recommendations for improving current sleep habits. Subjects will be contacted by telephone every 4 weeks during the 16-week intervention period.

Outcome Measures

Primary Outcome Measures :

1. Executive function (Stroop inhibition, Trails B-A, Controlled oral word association) [ Time Frame: 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.
2. Sleep Efficiency [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

Parkinson's Disease Foundation

More Information

• Responsible Party: Amy Amara, MD, Associate Professor of Neurology, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03495193
• Other Study ID Numbers: IRB-170324012
• First Posted: April 11, 2018
• Last Update Posted: April 26, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Only aggregate data will be shared.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amy Amara, MD, University of Alabama at Birmingham:

exercise

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases