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Resistance Training with Blood Flow Restriction for Parkinson's Disease (BFR-PD Trial)

N/A
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline (week 0) and post test (week 9)
Awards & highlights

BFR-PD Trial Summary

This trial will test how exercise can improve mobility, participation, and quality of life for people with advanced Parkinson's.

Who is the study for?
This trial is for adults aged 18-89 with Parkinson's Disease, specifically those at H&Y Stage 2 to Stage 4, indicating bilateral involvement up to severe disease. Participants must have impaired mobility (taking ≥11 seconds on the Timed Up and Go test) and be able to consent. Excluded are individuals with certain clotting disorders, other serious health conditions affecting rehabilitation safety, current supervised resistance training or recent blood flow restriction therapy.Check my eligibility
What is being tested?
The study tests low-load resistance training combined with blood flow restriction in people with advanced Parkinson's Disease. The goal is to see if this method is feasible and effective for improving mobility and quality of life. All participants will undergo the same intervention using a single cohort mixed-methods design.See study design
What are the potential side effects?
Potential side effects may include discomfort from the blood flow restriction cuffs, muscle soreness due to exercise, bruising where cuffs are applied, or exacerbation of existing symptoms due to physical strain.

BFR-PD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline (week 0) and post test (week 9)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline (week 0) and post test (week 9) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Ankle Plantarflexion
Change in Elbow Extension
Change in Knee Extension
Secondary outcome measures
Change in 30-second Sit-to-stand Completions
Change in Berg Balance Scale
Change in Self-Selected Walking Speed
+1 more
Other outcome measures
Change in Parkinson's Disease Questionnaire-39 Score
Change in Step Count

BFR-PD Trial Design

1Treatment groups
Experimental Treatment
Group I: Low-load resistance training with blood flow restrictionExperimental Treatment1 Intervention
Exercises will target bilateral 1) knee extensor, 2) ankle plantarflexor, and 3) elbow extensor muscles. Exercises will be dosed based on 1RM and individualized for each participant from a standardized exercise set. Progression will be based on 1) body position (supine, seated, standing), and 2) degree of resistance. Dosing will be re-assessed every 2 weeks and progressed as tolerated. Resistance will be provided by the Shuttle Mini-Press (Shuttle Systems), a portable resistance trainer that allows for precise dosing but is also adaptable to people with mobility limitations.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,735 Previous Clinical Trials
2,149,151 Total Patients Enrolled
Davis Phinney FoundationOTHER
4 Previous Clinical Trials
492 Total Patients Enrolled

Media Library

Low-load resistance training with blood flow restriction (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05806775 — N/A
Parkinson's Disease Research Study Groups: Low-load resistance training with blood flow restriction
Parkinson's Disease Clinical Trial 2023: Low-load resistance training with blood flow restriction Highlights & Side Effects. Trial Name: NCT05806775 — N/A
Low-load resistance training with blood flow restriction (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05806775 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age requirement to participate in this trial?

"The eligibility requirements for this research initiative states that the minimum age of participants is 18 and maximum age is 89."

Answered by AI

How many participants are being invited to join this experiment?

"Affirmative. The information uploaded to clinicaltrials.gov confirms that this research endeavour, with an initial posting date of April 1st 2023 is currently recruiting participants. Only one medical centre needs to enroll a total of twenty patients for the trial."

Answered by AI

Is it possible for me to register my participation in this clinical trial?

"This trial stipulates that individuals accepted must be diagnosed with Parkinson's disease, and between the ages of 18-89. 20 patients will eventually be recruited for this medical endeavor."

Answered by AI

Are there any available slots left in this trial for participants?

"Affirmative. Clinicaltrials.gov includes details that this medical study has resumed recruiting participants since April 1st 2023, with the last update being on April 13th 2023. Specifically, it is looking to include a total of 20 people at one single site."

Answered by AI

What are the primary outcomes researchers hope to achieve with this clinical study?

"The primary evaluation for this trial will be Change in Elbow Extension, measured at baseline (Week 0) and post-test (Week 9). Secondary measures include the Berg Balance Scale - a functional mobility test that assesses balance levels from 0 to 56 points with higher scores indicating more independent movement; Timed Up and Go Time - which quantifies how long it takes participants to stand up after sitting down, walk 10 feet, turn around, then sit back down again; and Self-Selected Walking Speed - gauging gait speed over a 10 meter course."

Answered by AI
~4 spots leftby Jul 2024