Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04000360
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-Intensity Aerobic Exercise (AE) — OTHER
    The home-based exercise group will have a Peloton indoor cycle, heart rate monitor strap, and Garmin activity monitor to track daily activity levels delivered to the home. Participants will be asked to cycle 3x/week for 12 months on this bike with heart rate monitor at aerobic intensity 60-80% of heart rate reserve and target cadence 80-90 revolutions per minute. Study team members will telephone all participants biweekly for similar contact times between treatment groups. During these calls, a study team member reviews fall diary information, inquires about possible adverse events, and reviews participants' activity monitor wear times on the Garmin Connect website (https://connect.garmin.com). For those in the AE group, exercise recommendations, e.g., increase duration, cadence or heart rate, are given based on review of exercise session data on the Peloton portal (onepeloton.com). Compliance barriers or technical challenges with the activity monitor or exercise cycle are addressed.
  • Usual and Customary Care (UCC) — OTHER
    Participants in this group will continue to receive their usual care. They will also receive activity monitors to monitor their daily activity levels, and telephone monitoring throughout the study. Study team members telephone all participants every 2 weeks for similar amounts of contact time between treatment groups. During the calls, a study team member of the reviews fall diary information, inquires about possible adverse events, and reviews participants' activity monitor wear times via the Garmin Connect website (https://connect.garmin.com).

Study Details

Identification of an effective disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral) is an unmet need in Parkinson's disease (PD). Increasing evidence indicates high intensity aerobic exercise is a candidate to alter PD progression. The primary aim of this study is to examine the disease-altering capabilities of a long-term, high-intensity aerobic exercise intervention. A multi-site pragmatic randomized controlled trial design has been selected. Individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive an indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Motor and non-motor assessments will be conducted at the main campus of the Cleveland Clinic or the University of Utah at enrollment, 6 months, and 12 months. Each assessment will last approximately one hour.

Key Dates

Start date
Nov 13, 2019
Status verified
Jun 2025
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023

Study Design

Enrollment
256 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-Intensity Exercise Group
    Mild to moderate Parkinson's disease patients: The exercise group will be asked to cycle 3x/week for 12 months on a Peloton bicycle which will be delivered to their home.
  • Other: Usual and Customary Care Group
    Mild to moderate Parkinson's disease patients, receiving no exercise intervention through the research but monitored with a parallel attention control. They will continue to receive usual and customary care for their Parkinson's disease during the 12 month period.

Primary Outcome Measure

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score [ Time Frame: Baseline, 6 months, 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195-
University of UtahSalt Lake CityUtah84108-

Find similar trials in Cleveland, OH

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Cleveland Clinic· Cleveland, OHUniversity of Utah· Salt Lake City, UT

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