Clinical trial NCT03495193: Impact of Exercise in Parkinson's Disease
Official title: Impact of a Novel Exercise Intervention on Executive Function and Sleep in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: exercise
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Parkinson's Disease Foundation
First posted: 2018-04-11
Enrollment: 4
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Executive function (Stroop inhibition, Trails B-A, Controlled oral word association)
timeFrame: changes from baseline to week 16
measure: Sleep Efficiency
timeFrame: changes from baseline and week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: