Low-load Resistance Training With Blood Flow Restriction in People With Parkinson's Disease

Last updated: April 15, 2025
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Low-load resistance training with blood flow restriction

Clinical Study ID

NCT05806775
22-2333
  • Ages 18-89
  • All Genders

Study Summary

The study's objective is to determine the feasibility of low-load resistance training with blood flow restriction in people who have advanced Parkinson's disease and impaired mobility using a mixed-methods convergent parallel design in a single cohort. The study's long-term goal is to develop clinically feasible exercise interventions that are effective at improving mobility, participation, and quality of life for people with advanced Parkinson's disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults ages 18-89 with neurologist-confirmed diagnosis of PD

  • H&Y Stage 2 (bilateral involvement without postural instability) up to H&Y Stage 4 (severe disease)

  • Able to provide informed consent

Exclusion

Exclusion Criteria:

  • H&Y Stage 1 (unilateral involvement only) or less

  • H&Y Stage 5 (wheelchair or bed bound)

  • Unable to provide consent or diagnosis of dementia

  • History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease,thrombophilia or other clotting disorders; report of easy bruising

  • Any comorbid conditions or pain that substantially affects ability to safelycomplete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, orongoing medical treatments) as determined by a neurologist or physical therapist

  • Currently undergoing supervised resistance training with a physical therapist orother exercise professional

  • Using Blood Flow Restriction currently or in the previous 3 months prior toenrollment

  • Cannot tolerate BFR pressure cuff inflated to 60% of total limb occlusion pressureduring baseline assessment

  • PD-related medication change in the month prior to enrollment

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Low-load resistance training with blood flow restriction
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
November 08, 2024

Study Description

This study will use a mixed-methods convergent parallel design to determine the feasibility of low-load BFR training in 20 people with advanced PD symptoms and impaired mobility (Hoehn and Yahr Stage [H&Y] 3-4). All participants will receive low intensity resistance training (20-30% of 1RM) with BFR targeting knee extensor, ankle plantarflexor, and elbow extensor muscles 2x/week for 8 weeks. Intervention will be delivered by a physical therapist with specialized training in BFR. Pre-defined feasibility criteria will be assessed in the primary aim. Outcomes assessed before and immediately after the 8-week intervention will include quantitative muscle strength and mobility assessments, and quantitative and qualitative data on health-related QOL.

Aim 1: Determine low-load BFR training feasibility based on the following quantitative and qualitative criteria: 1) enrolling 20 participants, 2) retaining ≥80% participants, 3) obtaining ≥80% intervention adherence, 4) having no serious intervention-related adverse events, and 5) quantitatively and qualitatively measured acceptability.

Aim 2: Determine changes in 1) knee extensor, ankle plantarflexor, and elbow extensor muscle strength using fixed myometry and 2) instrumented functional mobility (30-second Sit-to-Stand, Timed up and Go, self-selected walking speed, and Berg Balance Scale) using a system of inertial measurement unit wearable sensors.

Exploratory Aim: Understand health-related QOL changes using the Parkinson's Disease Questionnaire-39 (PDQ-39) and semi-structured interviews to elucidate how components of the intervention translate into QOL changes through a mixed-method analysis of PDQ-39 constructs of mobility, activities of daily living, emotional well-being, social stigma, social support, cognition, communications, and bodily discomfort.

Connect with a study center

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.