Blood Flow Restriction for Optimizing Balance in Parkinson's Disease

NCT ID: NCT06508801

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2026-12-31

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.

Detailed Description

Parkinson's disease (PD) is a disease of the nervous system that attacks the nerve cells in the brain responsible for controlling movement in the arms, legs and face. It is a progressive condition that gets worse with time. The purpose of this study is to determine the effects of blood flow restriction (BFR) in combination with strengthening exercises that challenge balance (instability resistance training (IRT)) to improve the symptoms of the participant's condition. This research is being done to understand the effects of BFR with IRT on symptoms of PD such as balance, mobility, walking and endurance. There will be two groups 1 and 2; group 1 will perform IRT with BFR and group 2 will perform IRT only. Each session with either intervention will last approximately 45 minutes. Researchers will test the effects of the intervention on the participant's walking ability, balance function and endurance. The researchers hope to learn whether low resistance exercises using these tight cuffs around the thighs are well tolerated by individuals with PD and determine whether there is an improvement in muscle strength, balance, and physical function. In addition, researchers will also use peripheral nerve stimulation techniques which are non-invasive (does not go inside the body). These techniques will be used to measure spinal excitability (i.e., nerve stimulator for testing strength of the pathway between spinal cord and muscles) in individuals with PD.

Conditions

Parkinson's Disease and Parkinsonism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

BFR plus IRT Group

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

Group Type: EXPERIMENTAL

Blood flow restriction training

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

IRT Only Control Group

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

Group Type: OTHER

Instability Resistance Training

Intervention Type: OTHER

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.

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

BFR; IRT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Anjali Sivaramakrishnan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anjali Sivaramakrishnan, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anjali Sivaramakrishnan, PhD, PT

Role: CONTACT

sivaramakris@uthscsa.edu

210-567-8626

Alyssa Main

Role: CONTACT

baezaa1@uthscsa.edu

210-567-8767

Facility Contacts

Anjali Sivaramakrishnan, PhD, PT

Role: primary

Other Identifiers

P30AG044271

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000472BFR

Identifier Type: -

Identifier Source: org_study_id