NCT07460609

Brief Summary

As people age, it can become harder to stay active and independent, especially when dealing with fatigue, joint pain, or other health problems. Heavy weightlifting and high-intensity exercise are effective but may not be comfortable or realistic for many older adults. This study is looking at a gentler type of exercise called blood flow restriction (BFR) training, which uses light weights and slow walking combined with special bands around the arms and legs to gently reduce blood flow during exercise. This method has been shown to help improve strength and fitness using much lighter loads, which may make it a safer and more accessible option for older adults. In this study, adults age 60 and older will be randomly assign into one of two groups: an exercise group or a health education group. The exercise group will take part in a six-week BFR program that includes supervised light resistance exercises and short walking sessions each week. The health education group will attend three educational sessions over six weeks that focus on healthy aging and ways to manage health and stay active. After the first six weeks, participants will have the chance to switch and take part in the other program, so everyone eventually receives both exercise and education. Before and after each program, participants will complete simple tests of strength, walking ability, and physical function, along with measurements of heart and blood vessel health, body composition, and blood markers related to aging and overall health. They will also fill out questionnaires about their quality of life, physical activity, and how they feel about their health and aging. The goal of this study is to find out whether BFR exercise and health education can support healthy aging, improve physical function, and help older adults feel more positive and confident about their health. What the study investigators learn may help create better, more accessible programs in the community to keep older adults stronger, healthier, and more independent.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

December 12, 2025

Last Update Submit

March 4, 2026

Conditions

Keywords

Healthy Agingolder adultsLow-load ExerciseHealth EducationPhysical FunctionVascular Health

Outcome Measures

Primary Outcomes (9)

  • Functional Exercise Capacity

    Measured by the distance in meters covered during a 6-minute walk.

    baseline and 6 weeks.

  • Grip Strength

    Measured with a hand grip dynamometry in kilograms

    Baseline and 6 weeks.

  • Lower Body Strength and Endurance

    Measured with a sit-to-stand test, seconds to complete 5 repetitions of sitting and standing from a chair.

    Baseline and 6 weeks

  • Body Composition

    Adiposity will be measured by Dual energy x-ray absorptiometry as percent of body fat

    Baseline and 6 weeks

  • Endothelial Function

    Measured via brachial artery flow mediated dilation. Percent FMD

    Baseline and 6 weeks

  • Biomarker of Genetic Aging

    Klotho a marker of aging will be quantified through blood samples analysis. Measured with Enzyme-Linked Immunosorbent Assay.

    Baseline and 6 weeks

  • Metabolic Health

    Cholestech LDX analyzer will measure levels of cholesterol HDL mg/dL from a finger prick sample.

    Baseline and 6 weeks

  • Metabolic Health

    Cholestech LDX analyzer will measure levels of cholesterol LDL mg/dL from a finger prick sample.

    baseline and 6 weeks.

  • Metabolic Health

    Cholestech LDX analyzer will measure levels of glucose mg/dL from a finger prick sample.

    Baseline and 6 weeks

Secondary Outcomes (2)

  • Body Mass Index (BMI)

    Baseline and 6 week

  • Blood Pressure

    Baseline and 6 weeks.

Other Outcomes (2)

  • Height

    Baseline and 6 weeks

  • Weight

    Baseline and 6 weeks

Study Arms (2)

Blood Flow Restriction Exercise Intervention

EXPERIMENTAL

Participants in this arm will complete a six-week blood flow restriction (BFR) exercise program. Training includes two weekly supervised sessions using low-load resistance exercises performed with BFR bands, along with two short BFR walking sessions completed at home. This program is designed to improve muscle strength, physical function, and cardiovascular health while using light exercise intensities that are well suited for older adults.

Behavioral: Blood Flow Restriction Training Exercise

Health Education Intervention

OTHER

Participants in this arm will take part in a six-week health education program consisting of three lectures sessions focused on healthy aging, disease prevention, and maintaining physical and mental well-being. Participants will continue their usual daily activities during this period. This arm serves as a comparison condition to evaluate how education alone influences perceptions of aging, health behaviors, and quality of life.

Behavioral: Health Education

Interventions

Participants will complete a six-week blood flow restriction exercise program consisting of low-load resistance training and short BFR walking sessions performed with standardized cuff pressures under supervision and at home to improve strength and functional capacity.

Blood Flow Restriction Exercise Intervention

Participants will attend a three health education lectures within six weeks on healthy aging, disease prevention, and lifestyle strategies while maintaining their usual daily activities.

Health Education Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling adults aged 60 years or older,
  • Able to walk independently ,
  • Willing to provide informed consent and participate in exercise and/or health education sessions.

You may not qualify if:

  • Adults with uncontrolled disease (unstable or recent angina, heart failure class III-IV,
  • Myocardial infarction within 6 months,
  • Uncontrolled hypertension,
  • Uncontrolled diabetes,
  • Recent deep vain thrombosis,
  • Uncontrolled renal disease,
  • Those with severe orthopedic or neuromuscular condition that limit safe exercise or walking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marrs McLean Gym

Waco, Texas, 76706, United States

Location

MeSH Terms

Conditions

Health Education

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2025

First Posted

March 10, 2026

Study Start

August 1, 2025

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations