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Exercise for Parkinson's Disease (EXCEL-PD Trial)
N/A
Recruiting
Led By Nijee Luthra, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of idiopathic Parkinson's disease (PD) based on MDS criteria, with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism.
Modified Hoehn and Yahr stage less than 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from weeks 5-26, every week
Awards & highlights
EXCEL-PD Trial Summary
This trial will study if home-based exercise helps Parkinson's patients, looking at cognitive effects and biomarkers.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves physical exercise, potential side effects may include muscle soreness, fatigue, joint pain or injury. However, these are common reactions to starting an exercise routine and usually subside as one adapts.
EXCEL-PD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Parkinson's disease, showing slow movement and either tremor or stiffness.
Select...
My Parkinson's disease is not in the most advanced stage.
EXCEL-PD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from weeks 5-26, every week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from weeks 5-26, every week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average number of days per week exercised
Average percent heart rate maximum (HR max)
Average repetition maximum
Secondary outcome measures
Change in biomarker of aging
Change in biomarker of stress
Other outcome measures
Change in cognitive function
Change in fitness
Change in isokinetic strength
+4 moreEXCEL-PD Trial Design
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 Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,519 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,553 Total Patients Enrolled
Nijee Luthra, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Parkinson's disease, showing slow movement and either tremor or stiffness.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.I am between 40 and 80 years old.You already exercise moderately for at least two hours every week.My Parkinson's disease is not in the most advanced stage.I do not have a major neurological condition other than Parkinson's disease.My Parkinson's disease medication doses have been stable for 2+ months, or I'm not on PD meds and likely won't need them for 6 months.My dose of mental health medication has been stable for over 30 days.I have heart, metabolism, or kidney disease, or symptoms of these without clearance for exercise.My condition is not primarily Parkinson's disease but may include symptoms similar to it.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise
- Group 2: Waitlist Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for this study inclusive of those aged 75 and over?
"The study's enrollment parameters state that individuals must be between 40 and 80 years of age in order to be considered for inclusion."
Answered by AI
Who has the credentials to be eligible for this medical research?
"This clinical trial requires 36 patients aged between 40 and 80, who are diagnosed with idiopathic Parkinson's disease according to the MDS criteria. Furthermore, these individuals must be at a Modified Hoehn and Yahr stage of less than 4 and their PD symptomatic medications need to have been on stable doses for over two months before they start the baseline tests. If they're not being medicated then it is expected that they will not require any medication in the following six month period."
Answered by AI
Has enrollment for this trial opened yet?
"According to clinicialtrials.gov, this research programme is not actively enrolling participants at the moment; nonetheless, it was initially posted on April 1st 2023 and recently edited 31 days later. Fortunately, there are 497 other clinical trials recruiting right now."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- University of California San Francisco: < 48 hours
Average response time
- < 2 Days
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