- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460609
Exploring Blood Flow Restriction as an Accessible Fitness Solution for Healthy Aging in Seniors
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Waco, Texas, United States, 76706
- Marrs McLean Gym
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blood Flow Restriction Exercise Intervention
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.
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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.
|
|
Other: Health Education Intervention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Exercise Capacity
Time Frame: baseline and 6 weeks.
|
Measured by the distance in meters covered during a 6-minute walk.
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baseline and 6 weeks.
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Grip Strength
Time Frame: Baseline and 6 weeks.
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Measured with a hand grip dynamometry in kilograms
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Baseline and 6 weeks.
|
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Lower Body Strength and Endurance
Time Frame: Baseline and 6 weeks
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Measured with a sit-to-stand test, seconds to complete 5 repetitions of sitting and standing from a chair.
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Baseline and 6 weeks
|
|
Body Composition
Time Frame: Baseline and 6 weeks
|
Adiposity will be measured by Dual energy x-ray absorptiometry as percent of body fat
|
Baseline and 6 weeks
|
|
Endothelial Function
Time Frame: Baseline and 6 weeks
|
Measured via brachial artery flow mediated dilation.
Percent FMD
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Baseline and 6 weeks
|
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Biomarker of Genetic Aging
Time Frame: Baseline and 6 weeks
|
Klotho a marker of aging will be quantified through blood samples analysis.
Measured with Enzyme-Linked Immunosorbent Assay.
|
Baseline and 6 weeks
|
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Metabolic Health
Time Frame: Baseline and 6 weeks
|
Cholestech LDX analyzer will measure levels of cholesterol HDL mg/dL from a finger prick sample.
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Baseline and 6 weeks
|
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Metabolic Health
Time Frame: baseline and 6 weeks.
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Cholestech LDX analyzer will measure levels of cholesterol LDL mg/dL from a finger prick sample.
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baseline and 6 weeks.
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Metabolic Health
Time Frame: Baseline and 6 weeks
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Cholestech LDX analyzer will measure levels of glucose mg/dL from a finger prick sample.
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: Baseline and 6 week
|
BMI will be determined using weight in kilogram and height in meters squared.
kg/m2
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Baseline and 6 week
|
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Blood Pressure
Time Frame: Baseline and 6 weeks.
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Blood pressure will be measured using an automated oscillometric sphygmomanometer to determine systolic and diastolic blood pressure in mmHg.
|
Baseline and 6 weeks.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: Baseline and 6 weeks
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Height will be measured in meters and will be used determine BMI kg/m2
|
Baseline and 6 weeks
|
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Weight
Time Frame: Baseline and 6 weeks
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Weight will be measure in kilograms with a floor scale, and will be used to determine BMI kg/m2
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Baseline and 6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Health Education
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Blood Flow Restriction Therapy
Other Study ID Numbers
- 2337478-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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