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

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ClinicalTrials.gov Identifier: NCT02593955
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : May 15, 2018
Sponsor:
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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 : September 1, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



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



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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

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): NCT02593955


Contacts
Contact: Amy Amara, MD, PhD 205-934-0683 amyamara@uab.edu
Contact: Allen Joop, MS 205-934-5954 joop1@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Amy Amara, MD    205-934-0683    amyamara@uab.edu   
Contact: Allen Joop    205-934-0683    joop1@uab.edu   
Principal Investigator: Amy Amara, MD         
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

Responsible Party: Amy Amara, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02593955     History of Changes
Other Study ID Numbers: F150612003
5K23NS080912 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases