The Effects of a High Intensity Exercise Training Program in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PD exercise
Sleep Hygiene
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: PD participants
- 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
- Hoehn and Yahr stage 2 or 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.
- 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.
- Age 45 or greater at time of study entry
- Asymmetric onset of PD
- Progressive motor symptoms of PD
- Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
- MoCA score 18-26
- 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
- Subjects must pass a physical examination and PAR-Q to assess exercise readiness
Inclusion Criteria: Healthy Controls
- Age 45 or greater at time of study entry
- Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
- Normal cognition
Exclusion Criteria: PD Participants
- 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.
- Neuroleptic treatment at time of onset of Parkinsonism
- Active treatment with a neuroleptic at time of study entry
- History of multiple strokes with stepwise progression of Parkinsonism
- History of multiple head injuries
- Inability to walk without assistance, including a cane, wheelchair, or walker
- Regular participation in an exercise program within the past 6 months
- Deep Brain Stimulation
- Untreated sleep apnea
- Known narcolepsy
- Participation in drug studies or the use of investigational drugs within 30 days prior to screening
- 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
- Known contraindication to testing
- Active alcoholism or other drug addiction
- Pregnancy
Exclusion criteria for PD subjects undergoing imaging studies:
- Pacemaker or other metallic object that would make MR imaging unsafe
- Claustrophobia that prevents participation in imaging portion
- 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:
- Pacemaker or other metallic object that would make MR imaging unsafe
- Claustrophobia that prevents participation in imaging portion
- Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
PD exercise group
PD sleep hygeine group
Healthy control
Arm Description
Supervised exercise training, 3x per week for 16 weeks
Tips for improved sleep hygiene, reading materials
MRI sub-study only
Outcomes
Primary Outcome Measures
Change in sleep efficiency measured by polysomnography
polysomnography
Vigilance outcome measured by psychomotor vigilance task (PVT)
psychomotor vigilance task (PVT)
Motor outcome measured by Timed up and go test (TUG)
Timed up and go test (TUG)
Secondary Outcome Measures
Home sleep environment
comparison of sleep diaries and actigraph related to home sleep environment
MRI Sub-study
comparison of PD and control imaging scans
Full Information
NCT ID
NCT02593955
First Posted
October 28, 2015
Last Updated
January 15, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT02593955
Brief Title
The Effects of a High Intensity Exercise Training Program in Patients With Parkinson's Disease
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD exercise group
Arm Type
Active Comparator
Arm Description
Supervised exercise training, 3x per week for 16 weeks
Arm Title
PD sleep hygeine group
Arm Type
Active Comparator
Arm Description
Tips for improved sleep hygiene, reading materials
Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
MRI sub-study only
Intervention Type
Behavioral
Intervention Name(s)
PD exercise
Intervention Description
Supervised high intensity exercise 3x/week for 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene
Intervention Description
Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.
Primary Outcome Measure Information:
Title
Change in sleep efficiency measured by polysomnography
Description
polysomnography
Time Frame
baseline, week 18, and week 34
Title
Vigilance outcome measured by psychomotor vigilance task (PVT)
Description
psychomotor vigilance task (PVT)
Time Frame
baseline, week 18, and week 34
Title
Motor outcome measured by Timed up and go test (TUG)
Description
Timed up and go test (TUG)
Time Frame
baseline, week 18, and week 34
Secondary Outcome Measure Information:
Title
Home sleep environment
Description
comparison of sleep diaries and actigraph related to home sleep environment
Time Frame
baseline, week 18 and week 34
Title
MRI Sub-study
Description
comparison of PD and control imaging scans
Time Frame
baseline (both PD and control), week 18 (PD only)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PD participants
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
Hoehn and Yahr stage 2 or 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.
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.
Age 45 or greater at time of study entry
Asymmetric onset of PD
Progressive motor symptoms of PD
Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
MoCA score 18-26
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
Subjects must pass a physical examination and PAR-Q to assess exercise readiness
Inclusion Criteria: Healthy Controls
Age 45 or greater at time of study entry
Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
Normal cognition
Exclusion Criteria: PD Participants
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.
Neuroleptic treatment at time of onset of Parkinsonism
Active treatment with a neuroleptic at time of study entry
History of multiple strokes with stepwise progression of Parkinsonism
History of multiple head injuries
Inability to walk without assistance, including a cane, wheelchair, or walker
Regular participation in an exercise program within the past 6 months
Deep Brain Stimulation
Untreated sleep apnea
Known narcolepsy
Participation in drug studies or the use of investigational drugs within 30 days prior to screening
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
Known contraindication to testing
Active alcoholism or other drug addiction
Pregnancy
Exclusion criteria for PD subjects undergoing imaging studies:
Pacemaker or other metallic object that would make MR imaging unsafe
Claustrophobia that prevents participation in imaging portion
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:
Pacemaker or other metallic object that would make MR imaging unsafe
Claustrophobia that prevents participation in imaging portion
Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Amara, MD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of a High Intensity Exercise Training Program in Patients With Parkinson's Disease
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