- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266961
Low-BFR vs Moderate-Intensity Resistance Training on Cardiorespiratory Fitness in Elderly Women
November 25, 2025 updated by: Dr. Soetomo General Hospital
The Effects of Low-Intensity Resistance Training Combined With Blood Flow Restriction Versus Moderate-Intensity Resistance Training on Cardiorespiratory Fitness in Elderly Women
This study is aiming to compare the CRF utilizing LIRT-BFR and MIRT in the elderly.
Both techniques provided comparable gains in VO₂ max and the BORG scale.
The BFR group displayed a greater level of safety for elderly to undertake resistance training with the same benefit as the MIRT group.
Study Overview
Status
Completed
Conditions
Detailed Description
Decreased cardiorespiratory fitness (CRF) is a common issue among older adults and contributes to reduced physical activity levels and quality of life.
While aerobic exercise is known to improve CRF, it has limited effects on muscle strength and mass.
In contrast, resistance training can enhance both cardiorespiratory and muscular fitness when performed at moderate intensity.
Blood flow restriction (BFR) applied during low-intensity resistance training (LIRT-BFR) has emerged as a promising alternative that may elicit similar physiological benefits to traditional moderate-intensity resistance training (MIRT) while reducing mechanical stress on joints and muscles.
This study aims to compare the effects of six weeks of LIRT-BFR versus MIRT on cardiorespiratory fitness in elderly women.
Twenty-eight participants were randomly assigned to either the LIRT-BFR group or the MIRT group and completed 12 supervised exercise sessions over six weeks.
The MIRT group performed exercises at 40-60% of one-repetition maximum (1-RM), while the LIRT-BFR group exercised at 20-30% of 1-RM under blood flow restriction.
The primary outcome was the predicted VO₂max obtained from the 6-Minute Walking Test (6MWT).
The secondary outcome was the rating of perceived exertion (RPE) measured using the modified Borg scale following the 6MWT.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
East Java
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Surabaya, East Java, Indonesia
- Department of Physical Medicine and Rehabilitation - Dr. Soetomo Regional Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female aged ≥60 years who routinely performed aerobic exercise in RSUD Dr. Soetomo
- Normal cognitive function (MoCA-Ina score ≥ 26)
- Passed the screening questionnaire.
Exclusion Criteria:
- Severe physical disability (presented with a musculoskeletal, cardiorespiratory, or neurological disease that affected physical performance during exercise)
- Visual and hearing impairment
- Balance impairment
- Blood clotting disorder
- Peripheral arterial disease on the legs
- Deep vein thrombosis
- Neuropathy in the lower extremity
- Uncontrolled hypertension or diabetes mellitus
- Previous stroke and compartment syndrome
- Knee osteoarthritis with moderate pain (VAS >4)
- Past vascular surgery
- Prior skin graft on the lower leg area
- Lower limb bone surgery within the past 12 weeks
- Immobilization during the last 4 weeks
- Statin consumption
- Sarcopenia
- Benign paroxysmal positional vertigo with an exacerbation in the previous 4 weeks.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LIRT-BFR group
The LIRT-BFR group used a cuff on the upper third of the thigh with a restriction pressure of 50 mmHg or 40% Arterial Occlusion Pressure to apply BFR while engaging in low-load resistance training that targeted the quadriceps femoris muscle at an intensity of 20-30% of 1-RM.
The resistance training protocol consists of four sets of knee extensions using an ankle weight in a sitting position.
Each set consists of 30 repetitions on the first set and 15 repetitions each on sets 2-4 with a 30-second interval between sets.
The air pressure cuff was deflated during the interval period.
In the third week, the weight load was recalculated to 40% of 1-RM in order to accommodate subsequent 1-RM testing procedures.
|
The LIRT-BFR group used a cuff on the upper third of the thigh with a restriction pressure of 50 mmHg or 40% Arterial Occlusion Pressure to apply BFR while engaging in low-load resistance training that targeted the quadriceps femoris muscle at an intensity of 20-30% of 1-RM.
The resistance training protocol consists of four sets of knee extensions using an ankle weight in a sitting position.
Each set consists of 30 repetitions on the first set and 15 repetitions each on sets 2-4 with a 30-second interval between sets.
The air pressure cuff was deflated during the interval period.
In the third week, the weight load was recalculated to 40% of 1-RM in order to accommodate subsequent 1-RM testing procedures.
|
|
Active Comparator: MIRT group
The MIRT group conducted three sessions of moderate-intensity resistance training, concentrating on the quadriceps femoris muscle, with weights set at 40-60% of their 1RM or higher.
While the MIRT protocol resembled that of LIRT-BFR, each session comprised 8-12 repetitions, followed by a 2-minute rest between sets.
In the third week, the 1-RM testing protocol was revised, with the weight adjusted to 60% of the 1-RM.
|
The MIRT group conducted three sets of moderate-intensity resistance training, concentrating on the quadriceps femoris muscle, with weights set at 40-60% of their 1RM or higher.
While the MIRT protocol resembled that of LIRT-BFR, each set comprised 8-12 repetitions, followed by a 2-minute rest between sets.
In the third week, the 1-RM testing protocol was revised, with the weight adjusted to 60% of the 1-RM.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO₂max
Time Frame: The VO₂max was measured before the intervention and after the intervention in the third and sixth weeks. The participants took a rest of at least 30 minutes after the resistance training to avoid fatigue in the legs, which could interfere with the 6MWD.
|
The main parameter evaluated in this study is cardiorespiratory fitness using VO₂max prediction value by carrying out a 6MWT.
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The VO₂max was measured before the intervention and after the intervention in the third and sixth weeks. The participants took a rest of at least 30 minutes after the resistance training to avoid fatigue in the legs, which could interfere with the 6MWD.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BORG RPE Scale
Time Frame: RPE was measured with the BORG Scale 6-20 to determine the participant's level of difficulty and exertion after the 6 MWT. The evaluation of RPE was continued for 60 minutes as guarantee the participant's safety and to monitor the complications.
|
The BORG RPE scale was used to measure a person's effort and exertion, dyspnea, and exhaustion during physical labor.
RPE was measured with the BORG Scale 6-20 to determine the participant's level of difficulty and exertion after the 6 MWT.
|
RPE was measured with the BORG Scale 6-20 to determine the participant's level of difficulty and exertion after the 6 MWT. The evaluation of RPE was continued for 60 minutes as guarantee the participant's safety and to monitor the complications.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nuniek Nugraheni Sulistiawaty, Department of Physical Medicine and Rehabilitation - Dr. Soetomo Regional Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
November 25, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- DrSoetomoLIRT-BFR&MIRT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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