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Completed

NCT Number: NCT05806775

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, or ongoing medical treatments) as determined by a neurologist or physical therapist
  • Currently undergoing supervised resistance training with a physical therapist or other exercise professional
  • Using Blood Flow Restriction currently or in the previous 3 months prior to enrollment
  • Cannot tolerate BFR pressure cuff inflated to 60% of total limb occlusion pressure during baseline assessment
  • PD-related medication change in the month prior to enrollment

Treatment and study plan

Low-load resistance training with blood flow restriction

Behavioral

A licensed physical therapist, will deliver intervention to all participants (2x/wk, 8 wks) using an FDA-cleared BFR system, the Delfi PTSII (Delfi Medical Innovations). The pressure cuff will be placed at the most proximal portion of the limb and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with a minimum of 60% and a maximum of 80% limb occlusion pressure. At 60-80% limb occlusion pressure there is diminished venous outflow to induce the necessary metabolic effect while still allowing arterial flow for safety. Individual limb occlusion pressures will be determined at the beginning of each session automatically by the Delfi PTSII device.

Primary outcomes

  1. Change in Knee Extension

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    Knee extension muscle strength measured using fixed myometry (QMA Muscle Testing System)

  2. Change in Ankle Plantarflexion

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    Ankle plantarflexion muscle strength measured using fixed myometry (QMA Muscle Testing System)

  3. Change in Elbow Extension

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    Elbow extension muscle strength measured using fixed myometry (QMA Muscle Testing System)

Secondary outcomes

  1. Change in 30-second Sit-to-stand Completions

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds

  2. Change in Timed Up and Go Time

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    Functional mobility test measuring the time required to stand from sitting, walk 10 feet, turn and return to seated position at starting point

  3. Change in Self-Selected Walking Speed

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    Gait speed measured over a 10-meter walking course, measured in seconds

  4. Change in Berg Balance Scale

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    Functional mobility test measuring the participant's ability to balance in different postures. Scores on the Berg Balance Scale range from 0 to 56 points, with 0-20 points indicating wheelchair bound, 21-40 indicating walking with assistance, and 41-56 indicating walking independently.

Other outcomes

  1. Change in Step Count

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    10-day average step count as measured by a wearable activity monitor

  2. Change in Parkinson's Disease Questionnaire-39 Score

    Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)

    39 item questionnaire measuring quality of life in people with Parkinson's disease. Scores range from 0 to 100 with lower scores indicating higher quality of life

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Davis Phinney Foundation

Registry information

Official study title

Feasibility of Low-load Resistance Training With Blood Flow Restriction in People With Advanced Disability Due to Parkinson's Disease

Acronym: BFR-PD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2023
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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