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

Parkinson's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593955
• Other study ID #: F150612003
• Secondary ID: 5K23NS080912
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• PD exercise
Supervised high intensity exercise 3x/week for 16 weeks
• Sleep Hygiene
Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep efficiency measured by polysomnography	polysomnography	baseline, week 18, and week 34
Primary	Vigilance outcome measured by psychomotor vigilance task (PVT)	psychomotor vigilance task (PVT)	baseline, week 18, and week 34
Primary	Motor outcome measured by Timed up and go test (TUG)	Timed up and go test (TUG)	baseline, week 18, and week 34
Secondary	Home sleep environment	comparison of sleep diaries and actigraph related to home sleep environment	baseline, week 18 and week 34
Secondary	MRI Sub-study	comparison of PD and control imaging scans	baseline (both PD and control), week 18 (PD only)