The Effects of a High Intensity Exercise Training Program in Patients With Parkinson's Disease

The Effects of a High Intensity Exercise Training Program on Sleep and Vigilance in Patients With Parkinson's Disease (The Effect of Low Frequency STN DBS on Sleep and Vigilance in PD Patients)

The purpose of this randomized, controlled interventional study is to determine the effects of a high intensity exercise training program on objective sleep measures, daytime sleepiness, mobility, and brain health/functional connectivity in patients with Parkinson's disease.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: PD exercise; Behavioral: Sleep Hygiene

Detailed Description

The primary outcome measure is the change in sleep efficiency (the number of minutes asleep divided by the number of minutes in bed), as measured by polysomnography. In addition, because patients with Parkinson's disease have excessive sleepiness/impaired vigilance (alertness) and impaired motor function, and because these might be expected to improve with the exercise intervention, this study will also assess vigilance and motor outcomes.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria: PD participants

1. Subjects with a clinical diagnosis of idiopathic Parkinson's disease based on the presence of bradykinesia and one or both of the following: rest tremor and/or rigidity
2. Hoehn and Yahr stage 2 or 3
3. Stable dopaminergic medication regimen for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
4. Stable doses of medications known to affect sleep and medications for Parkinson's disease for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
5. Age 45 or greater at time of study entry
6. Asymmetric onset of PD
7. Progressive motor symptoms of PD
8. Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
9. MoCA score 18-26
10. Ability to travel to UAB 3x/week for the 16 weeks duration of the study for exercise training sessions as well as for other study visits
11. Subjects must pass a physical examination and PAR-Q to assess exercise readiness

Inclusion Criteria: Healthy Controls

1. Age 45 or greater at time of study entry
2. Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
3. Normal cognition

Exclusion Criteria: PD Participants

1. Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
2. Neuroleptic treatment at time of onset of Parkinsonism
3. Active treatment with a neuroleptic at time of study entry
4. History of multiple strokes with stepwise progression of Parkinsonism
5. History of multiple head injuries
6. Inability to walk without assistance, including a cane, wheelchair, or walker
7. Regular participation in an exercise program within the past 6 months
8. Deep Brain Stimulation
9. Untreated sleep apnea
10. Known narcolepsy
11. Participation in drug studies or the use of investigational drugs within 30 days prior to screening
12. Acute illness or active, confounding medical, neurological, or musculoskeletal conditions that, at the discretion of the PI, would prevent the subject's ability to participate in the study
13. Known contraindication to testing
14. Active alcoholism or other drug addiction
15. Pregnancy

Exclusion criteria for PD subjects undergoing imaging studies:

1. Pacemaker or other metallic object that would make MR imaging unsafe
2. Claustrophobia that prevents participation in imaging portion
3. Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion

Exclusion criteria for healthy controls:

1. Pacemaker or other metallic object that would make MR imaging unsafe
2. Claustrophobia that prevents participation in imaging portion
3. Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PD exercise group; Supervised exercise training, 3x per week for 16 weeks	Behavioral: PD exercise; Supervised high intensity exercise 3x/week for 16 weeks
Active Comparator: PD sleep hygeine group; Tips for improved sleep hygiene, reading materials	Behavioral: Sleep Hygiene; Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.
No Intervention: Healthy control; MRI sub-study only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep efficiency measured by polysomnography	polysomnography	baseline, week 18, and week 34
Vigilance outcome measured by psychomotor vigilance task (PVT)	psychomotor vigilance task (PVT)	baseline, week 18, and week 34
Motor outcome measured by Timed up and go test (TUG)	Timed up and go test (TUG)	baseline, week 18, and week 34

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home sleep environment	comparison of sleep diaries and actigraph related to home sleep environment	baseline, week 18 and week 34
MRI Sub-study	comparison of PD and control imaging scans	baseline (both PD and control), week 18 (PD only)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Amy Amara, MD, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: F150612003; 5K23NS080912 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No