Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 16, 2026
Date Accepted: May 28, 2026
EXCEL-PD Study: protocol for a home-based, virtually supervised combined exercise intervention in people with Parkinson’s disease (randomized-controlled trial)
ABSTRACT
Background:
Cognitive impairment begins early in Parkinson's disease (PD) and progresses to dementia in most people with PD, reducing quality of life and contributing to growing health-related costs. Physical exercise has potent anti-aging effects and improves many outcomes in PD including cognition. Identifying biomarkers that respond to exercise, and how they associate with cognition and underlying disease pathology, may elucidate key mechanisms for countering cognitive decline.
Objective:
This clinical trial will test the feasibility, adherence, and safety of a 26-week combined endurance and resistance exercise intervention in people with PD. Secondary objectives are to test the effects of the exercise intervention on (1) global cognition (2) motor symptom progression and (3) circulating fluid-based biomarker levels.
Methods:
The Exercise for Cognitive Excellence in Parkinson’s Disease (EXCEL-PD) study is a randomized-controlled trial that evaluates feasibility, adherence, and safety of a home-based exercise intervention in people with PD and measures its effects on cognition, motor progression, and circulating biomarkers. Thirty-one participants with PD will be randomized to either a home-based, trainer-supervised endurance and resistance training program (exercise group) or a wait list control group for 26 weeks. Feasibility will be assessed using average percentage of maximum heart rate for aerobic exercise and repetition maximums for resistance exercise. Adherence will be assessed using average duration of exercise at target heart rate intensity for aerobic exercise and average days per week and duration of exercise for resistance exercise. Safety will be assessed using adverse events and serious adverse events. The efficacy of the combined endurance and resistance exercise intervention will be measured using cognitive assessments, the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), and participant-reported outcomes, all obtained at baseline and 26 weeks. Biomarkers in periphery (blood, saliva) and brain (cerebrospinal fluid) will also be measured before and after the 26-week exercise intervention.
Results:
Recruitment commenced in July 2023 and Concluded in November 2025. The last participant will complete data collection in May of 2026. Data will be analyzed starting in June of 2026, and results are expected to be published in late 2026 and early 2027.
Conclusions:
Previous studies have shown that high intensity endurance exercise effectively slows the progression of motor symptoms in PD, and that resistance exercise effectively improves cognition in PD. Establishing whether a clinically relevant, combined endurance and resistance exercise intervention is safe and feasible in PD, and can improve cognition and slow motor disease progression would have a significant impact on quality of life for those with PD and their caregivers. Understanding how biomarkers respond to exercise will shed important mechanistic insight. Clinical Trial: Clinicaltrials.gov, NCT05720468, Registered on January 31st, 2023, https://clinicaltrials.gov/study/NCT05720468.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.