36 Participants Needed

Exercise for Parkinson's Disease

(EXCEL-PD Trial)

NL
Overseen ByNijee Luthra, MD, PhD
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that if you are taking Parkinson's disease medications, your doses must be stable for at least 2 months before starting. If you are not on these medications, you should not need them for the next 6 months. Other medications, like certain psychotropic drugs, need to have stable doses for at least 30 days before starting.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training, No Exercise for Parkinson's Disease?

Research shows that exercise can provide short-term benefits for people with Parkinson's disease, such as improving strength, balance, and mobility.12345

Is exercise safe for people with Parkinson's disease?

Exercise, including activities like cycling, resistance training, and endurance training, is generally safe for people with Parkinson's disease and does not worsen symptoms. It can be a beneficial addition to medical treatment, improving aspects like balance and quality of life.678910

How does exercise differ from other treatments for Parkinson's disease?

Exercise for Parkinson's disease is unique because it focuses on improving movement and reducing disability through physical activity, such as dance, deep-water exercises, and boxing, rather than using medication. These activities can enhance balance, mobility, and quality of life, offering a non-drug approach to managing symptoms.311121314

What is the purpose of this trial?

This study will evaluate the safety and feasibility of a home-based, virtually-supervised, combined high intensity endurance and resistance training program in people with Parkinson's disease. It will also evaluate the effects of exercise on cognition and underlying exercise-related biological markers (biomarkers).

Research Team

NL

Nijee Luthra, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for people aged 40-80 with Parkinson's disease who are stable on their PD medications or unlikely to need them in the next 6 months. They should be able to follow exercise instructions without significant cognitive impairment (MoCA score ≥23) and not have severe depression (BDI ≤16). Participants must not have major cardiovascular, metabolic, renal diseases, or other conditions that would make exercising unsafe.

Inclusion Criteria

I have been diagnosed with Parkinson's disease, showing slow movement and either tremor or stiffness.
I am between 40 and 80 years old.
My Parkinson's disease is not in the most advanced stage.
See 1 more

Exclusion Criteria

You have a medical condition or injury that may make it difficult for you to exercise.
I have not used neuroleptics or dopamine blockers in the last 30 days.
I haven't been seriously ill or hospitalized in the last month.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a home-based, trainer-supervised endurance and resistance training program for 26 weeks

26 weeks
Virtually supervised sessions 5 days per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants in the waitlist control group are offered the exercise program after the 26-week study period

26 weeks

Treatment Details

Interventions

  • Exercise
  • No Exercise
Trial Overview The study tests a home-based exercise program using high intensity endurance and resistance training for those with Parkinson's. It looks at how this affects cognition and biological markers related to exercise. Some participants will do exercises while others won't, allowing comparison of effects.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExerciseExperimental Treatment1 Intervention
Participants randomized to the exercise group will receive 26 weeks of home-based, combined endurance and resistance training program under guidance and virtual supervision from exercise trainers. Exercise will be performed 5 days per week, with 3 days of endurance training using treadmill and 2 days of resistance training.
Group II: Waitlist Control GroupPlacebo Group1 Intervention
The control group will continue usual level of physical activity the participants were doing prior to enrollment in the study. At the end of the 26 week study period, participants will be offered the chance to participate in the same home-based, combined endurance and resistance training program.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Findings from Research

Exercise is a crucial part of managing Parkinson's disease (PD) and is shown to improve physical fitness, but there is a lack of standardized recommendations due to the variability in exercise interventions across 83 clinical trials.
The most common exercise prescription found was multimodal exercise for 60 minutes, twice a week over 12 weeks, highlighting the need for increased physical activity levels as an effective strategy for PD management.
Physical Activity, Exercise, and Physiotherapy in Parkinson's Disease: Defining the Concepts.Bouça-Machado, R., Rosário, A., Caldeira, D., et al.[2022]
A survey of 64 Parkinson's Disease patients revealed that 67% exercised at least twice a week, with walking being the most common form of exercise, and 97% reported improvements in their symptoms due to exercise.
Patients who exercised in groups experienced greater symptomatic improvements compared to those who exercised alone, highlighting the potential added benefits of social interaction and cognitive engagement in group activities like dance therapy.
Self-Reported Exercise Trends in Parkinson's Disease Patients.Raje, P., Ning, S., Branson, C., et al.[2019]
A review of seven studies indicates that physical exercise significantly improves physical performance and activities of daily living in patients with Parkinson's disease, including enhancements in strength, balance, and mobility.
The findings suggest a need for standardized exercise programs tailored to Parkinson's disease and longer-term studies to evaluate the sustainability of these improvements beyond the intervention period.
Is physical exercise beneficial for persons with Parkinson's disease?Crizzle, AM., Newhouse, IJ.[2006]

References

Physical Activity, Exercise, and Physiotherapy in Parkinson's Disease: Defining the Concepts. [2022]
Self-Reported Exercise Trends in Parkinson's Disease Patients. [2019]
Is physical exercise beneficial for persons with Parkinson's disease? [2006]
Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. [2022]
Phase II randomised controlled trial of a 6-month self-managed community exercise programme for people with Parkinson's disease. [2021]
Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. [2022]
FIGHT-PD: A feasibility study of periodized boxing training for Parkinson disease. [2023]
Therapeutic effects of forced exercise cycling in individuals with Parkinson's disease. [2021]
Physical Activity in De Novo Parkinson Disease: Daily Step Recommendation and Effects of Treadmill Exercise on Physical Activity. [2021]
Boxing for Parkinson's Disease: Has Implementation Accelerated Beyond Current Evidence? [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Boxing training for patients with Parkinson disease: a case series. [2022]
12.Korea (South)pubmed.ncbi.nlm.nih.gov
The Efficacy of Exercise Programs for Parkinson's Disease: Tai Chi versus Combined Exercise. [2021]
Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. [2022]
Effectiveness of resistance training on muscle strength and physical function in people with Parkinson's disease: a systematic review and meta-analysis. [2018]
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