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Impact of Exercise in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495193
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Parkinson's Disease Foundation
Information provided by (Responsible Party):
Amy Amara, MD, 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.

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.

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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

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495193


Locations
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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
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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    Key Record Dates
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.

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