Recruiting

Blood Flow Restriction

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06508801

Conditions

Parkinson's Disease and Parkinsonism

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Blood flow restriction training

Instability Resistance Training

Study Details

Brief summary:

This study is being done to understand how reducing blood flow (BRT) during balance-challenging strengthening exercises (instability resistance training, or IRT) can help improve symptoms of Parkinson's disease.

Conditions

Parkinson's Disease and Parkinsonism

Study ID

NCT06508801

Start date

Jan 7, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and females between the ages 40 - 85 with a diagnosis of idiopathic Parkinson's Disease (PD) consistent with the United Kingdom PD society brain bank criteria,
2. in Hoehn and Yahr stage 2-4,
3. a score of ≥23 on the mini-Mental Scale Examination.

Exclusion Criteria:

1. History of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), orthostatic hypotension, deep-vein thrombosis, varicose veins, or rhabdomyolysis;
2. Ankle branchial index ≤ 0.9 or > 1.3.
3. History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy.
4. History of uncontrolled diabetes, severe osteoporosis, or cognitive impairment.
5. Body mass index above 40; such individuals are more likely to have poorer muscle function and more pain.
6. Absolute contraindications to exercise as per the American College of Sports Medicine (uncontrolled arrhythmias, third-degree heart block, recent electrocardiogram (EKG) changes, unstable angina, acute myocardial infarction, or acute congestive heart failure
7. Had surgery in the lower extremities within the past 6 months.
8. Pre-menopausal and not on birth control
9. Pregnant or planning to become pregnant within the course of the study
10. Plan to have major surgery within 2 months.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: BFR plus IRT Group

Blood Flow Restriction plus Instability Resistance Training group. Participants will receive 2 sessions per week over 6 weeks.

other: IRT Only Control Group

Instability Resistance Training only group. Participants will receive 2 sessions per week over 6 weeks.

Interventions

Blood flow restriction training

The BFR Intervention will consist of 75 repetitions; reps (set 1: 30 reps, sets 2 - 4: 15 reps with 30 s of rest between sets and 1 minute between exercises) at 20-30% of 10 repetition maximum (RM). BFR training will be performed during toe raises, lunges and single leg stance exercises on unstable surfaces (i.e., foam, Dyna disc, balance disc, and BOSU-ball®) as tolerated by the participant.

Instability Resistance Training

The following devices will be used for instability training: foam, dyna disc, balance disc and BOSU-ball®. Unstable devices will be changed during the six-week period from the least to the most unstable devices. Once a participant reduces the body sway on a device, the device will be progressed. Participants will perform IRT with or without blood flow restriction.

Primary outcome measure

  • Feasibility metric [ Time Frame: Baseline to 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • Blood flow restriction
  • Instability resistance training
  • Balance
  • Strength
  • Postural control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-03-31.