The Effects of a High Intensity Exercise Training Program in Patients With Parkinson's Disease
2 other identifiers
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedStudy Start
First participant enrolled
November 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedJanuary 17, 2019
January 1, 2019
Same day
October 28, 2015
January 15, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Change in sleep efficiency measured by polysomnography
polysomnography
baseline, week 18, and week 34
Vigilance outcome measured by psychomotor vigilance task (PVT)
psychomotor vigilance task (PVT)
baseline, week 18, and week 34
Motor outcome measured by Timed up and go test (TUG)
Timed up and go test (TUG)
baseline, week 18, and week 34
Secondary Outcomes (2)
Home sleep environment
baseline, week 18 and week 34
MRI Sub-study
baseline (both PD and control), week 18 (PD only)
Study Arms (3)
PD exercise group
ACTIVE COMPARATORSupervised exercise training, 3x per week for 16 weeks
PD sleep hygeine group
ACTIVE COMPARATORTips for improved sleep hygiene, reading materials
Healthy control
NO INTERVENTIONMRI sub-study only
Interventions
Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.
Eligibility Criteria
You may qualify if:
- 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
- Age 45 or greater at time of study entry
- Poor sleep quality (Pittsburgh Sleep Quality Index score \>5)
- Normal cognition
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (2)
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PMID: 38588457DERIVEDErnst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PMID: 36602886DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Amara, MD, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 28, 2015
First Posted
November 2, 2015
Study Start
November 30, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
January 17, 2019
Record last verified: 2019-01