Blood Flow Restriction for Optimizing Balance in Parkinson's Disease

NCT06508801 | Recruiting DMC

• 2 other identifiers: STUDY00000472BFRP30AG044271
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility metric

  The treatment will be considered acceptable if the dropout and significant adverse event rate is less than 20%, that is no more than 2 out of 10 participants in the treatment group either 1) drop out, 2) withdraw consent, or 3) have a significant adverse event (Grade 3 or higher on 5 point scale where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death). Results will be reported as percentage of participants that dropped out.

  Baseline to 6 weeks

Secondary Outcomes (9)

• Balance Measure

  Baseline to 14 weeks

• Functional Mobility

  Baseline to14 weeks

• Movement Disorder Society Unified Parkinson's Disease Rating Scale

  Baseline to 14 weeks

• Postural Sway (Biosway)

  Baseline to 14 weeks

• Spinal Excitability Assessment

  Baseline to 14 weeks

Study Arms (2)

BFR plus IRT Group

EXPERIMENTAL

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

Other: Blood flow restriction training; Other: Instability Resistance Training

IRT Only Control Group

OTHER

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

Other: Instability Resistance Training

Interventions

Blood flow restriction training 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.

Also known as: BFR

BFR plus IRT Group

Instability Resistance Training 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.

Also known as: IRT

BFR plus IRT Group; IRT Only Control Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• in Hoehn and Yahr stage 2-4,
• a score of ≥23 on the mini-Mental Scale Examination.

You may not qualify if:

• History of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), orthostatic hypotension, deep-vein thrombosis, varicose veins, or rhabdomyolysis;
• Ankle branchial index ≤ 0.9 or \> 1.3.
• 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.
• History of uncontrolled diabetes, severe osteoporosis, or cognitive impairment.
• Body mass index above 40; such individuals are more likely to have poorer muscle function and more pain.
• 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
• Had surgery in the lower extremities within the past 6 months.
• Pre-menopausal and not on birth control
• Pregnant or planning to become pregnant within the course of the study
• Plan to have major surgery within 2 months.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Anjali Sivaramakrishnan, PhD, PT

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anjali Sivaramakrishnan, PhD, PT

CONTACT

210-567-8626; sivaramakris@uthscsa.edu

Alyssa Main

CONTACT

210-567-8767; baezaa1@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study will utilize block randomization with permuted blocks in a 1:1 ratio. Individuals will be assigned to either Group 1 or Group 2 after baseline assessment. The randomization will be predetermined, and the allocation will be concealed. Only the statistician and research coordinator will be aware of the randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two group, randomized, repeated measure design

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: At the time of publication in a peer reviewed journal

Locations

US (1)