Impact of a Novel Exercise Intervention on Executive Function and Sleep in Patients With Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Sleep Efficiency
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Exercise Group
Subjects randomized to the exercise training group will complete 16 weeks of exercise training. Exercise training will be performed 3x/week.
Intervention: Exercise training (Other)
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.
Intervention: Sleep hygiene (Behavioral)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amy Amara, MD
Associate Professor of Neurology
University of Alabama at Birmingham