Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04000360
Brief Summary:
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.
Detailed Description:
Overview of Experimental Design: The study is a randomized controlled clinical trial designed to examine the disease-altering capabilities of a 12 month aerobic exercise program for individuals with PD. A total of 252 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 a commercially available Peloton 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. Both groups will undergo a series of motor and non-motor assessments at enrollment, 6 months, and 12 months to measure disease progression of the 12 month period. Additionally, data will be used to develop a prognostic model to predict 12-month change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) for patients participating in a home-based high-intensity aerobic exercise program.
Study:
NCT04000360
Study Brief:
Protocol Section:
NCT04000360