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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Indonesia
    • East Java
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Low Intensity Resistance Training and Blood Flow Resistance
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.
Other: Moderate Intensity Resistance Training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Soetomo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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