# CYClical Lower Extremity exercise for Parkinsons trial (CYCLE Trial)

> **NIH NIH R01** · CLEVELAND CLINIC LERNER COM-CWRU · 2022 · $594,771

## Abstract

PROJECT SUMMARY/ABSTRACT
Despite advances in pharmaceutical and surgical approaches to the treatment of Parkinson’s disease (PD), an
effective disease modifying treatment remains elusive. Exercise is accepted as an adjunctive treatment to the
disease; however, its disease altering properties are unclear. Data indicate that high intensity exercise has
neuroprotective properties and improves motor functioning in animal models of PD. Our promising translational
work in humans indicated aerobic exercise improves global motor function, upper extremity performance, and
altered patterns of central nervous system activation. We recently completed a 100 person randomized clinical
trial, CYClical Lower Extremity exercise for Parkinson’s trial (CYCLE Trial) (NIH R01NS673717), and results
indicated an 8-week high intensity aerobic exercise program significantly improved MDS-UPDRS III scores,
turning and gait speed, and information processing. The positive results persisted up to eight weeks after
exercise cessation. These positive results provide strong rationale to evaluate the effectiveness of a long-term
CYCLE protocol in a home-based setting in an effort to impact a greater number of individuals with PD. The
primary aim of this project is to determine if long-term, high intensity aerobic exercise alters disease
progression in individuals with PD. A pragmatic randomized clinical trial is proposed in which blinded clinical
assessments will be coupled with biomechanical measures of motor and non-motor performance to determine
the impact of high-intensity exercise on PD progression. In sum, 250 PD patients recruited from the Cleveland
Clinic and University of Utah will be randomized to a high-intensity home exercise or usual and customary care
(UCC) group. The CYCLE Trial protocol will be delivered to the home of the exercise group through the
consumer-based Peloton Indoor Cycle, and participants will be instructed to exercise 3x/week for 12 months;
the UCC group will be instructed to engage in their normal activities. The exercise and control groups will
undergo identical motor and non-motor evaluation protocols at enrollment, 3, 6, 9, and 12 months. In addition
to clinical measures such as the MDS-UPDRS III, systematic quantification of motor and non-motor outcomes
will be collected using the PD-Performance Test (PD-PT), a validated set of biomechanical-based iPad
applications created in Dr. Alberts’ lab. Overall activity levels will be monitored for both groups via a wearable
sensor. Combining clinical and biomechanical measures of motor and cognitive performance will accelerate
the investigation and understanding of potential mechanisms underlying the positive effects of exercise on
disease progression. Finally, exercise performance data including heart rate, cadence and power from each
session will be gathered to monitor exercise compliance and build an exercise response predictive model. The
model will facilitate a transition from general recommendatio...

## Key facts

- **NIH application ID:** 10399535
- **Project number:** 5R01NS073717-09
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** JAY L. ALBERTS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $594,771
- **Award type:** 5
- **Project period:** 2011-09-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10399535

## Citation

> US National Institutes of Health, RePORTER application 10399535, CYClical Lower Extremity exercise for Parkinsons trial (CYCLE Trial) (5R01NS073717-09). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10399535. Licensed CC0.

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