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Completed

NCT Number: NCT02593955

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PD exercise

Behavioral

Supervised high intensity exercise 3x/week for 16 weeks

Sleep Hygiene

Behavioral

Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2015
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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