Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

NACompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

November 13, 2019

Primary Completion Date

April 30, 2023

Study Completion Date

April 30, 2023

Conditions
Parkinson Disease
Interventions
OTHER

High-Intensity Aerobic Exercise (AE)

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.

OTHER

Usual and Customary Care (UCC)

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).

Trial Locations (2)

44195

Cleveland Clinic, Cleveland

84108

University of Utah, Salt Lake City

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

University of Utah

OTHER

lead

The Cleveland Clinic

OTHER

NCT04000360 - Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease | Biotech Hunter | Biotech Hunter