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

• ClinicalTrials.gov Identifier: NCT02593955
• Recruitment Status: Completed
• First Posted: November 1, 2015
• Last Update Posted: January 17, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institutes of Health (NIH); National Institute of Neurological Disorders and Stroke (NINDS)
• Information provided by (Responsible Party): Amy Amara, MD, University of Alabama at Birmingham

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Behavioral: PD exercise; Behavioral: Sleep Hygiene	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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)
• Actual Study Start Date: November 30, 2018
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: November 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in sleep efficiency measured by polysomnography [ Time Frame: baseline, week 18, and week 34 ]
   polysomnography
2. Vigilance outcome measured by psychomotor vigilance task (PVT) [ Time Frame: baseline, week 18, and week 34 ]
   psychomotor vigilance task (PVT)
3. Motor outcome measured by Timed up and go test (TUG) [ Time Frame: baseline, week 18, and week 34 ]
   Timed up and go test (TUG)

Secondary Outcome Measures :

1. Home sleep environment [ Time Frame: baseline, week 18 and week 34 ]
   comparison of sleep diaries and actigraph related to home sleep environment
2. MRI Sub-study [ Time Frame: baseline (both PD and control), week 18 (PD only) ]
   comparison of PD and control imaging scans

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

National Institutes of Health (NIH)

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Amy Amara, MD, PhD; University of Alabama at Birmingham

More Information

• Responsible Party: Amy Amara, MD, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02593955
• Other Study ID Numbers: F150612003; 5K23NS080912 ( U.S. NIH Grant/Contract )
• First Posted: November 1, 2015
• Last Update Posted: January 17, 2019
• Last Verified: January 2019

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

Additional relevant MeSH terms:

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