CClinicalTrials.gg
CompletedNCT07266961Updated Dec 5, 2025

Low-BFR vs Moderate-Intensity Resistance Training on Cardiorespiratory Fitness in Elderly Women

An interventional study of Low Intensity Resistance Training and Blood Flow Resistance and Moderate Intensity Resistance Training in Cardiorespiratory Fitness, sponsored by Dr. Soetomo General Hospital. Completed at 1 site in Indonesia. Open to female participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Dr. Soetomo General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jun 2023, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years and older
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Cardiorespiratory Fitness
03

In context

Lead sponsor

Dr. Soetomo General Hospital is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherLow 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.

  • OtherModerate 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.

06

What researchers measure

Primary outcomes

  1. VO₂max

    The main parameter evaluated in this study is cardiorespiratory fitness using VO₂max prediction value by carrying out a 6MWT.

    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.

Secondary outcomes

  1. BORG RPE Scale

    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.

    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.

07

Study locations

1 site
  • Department of Physical Medicine and Rehabilitation - Dr. Soetomo Regional Hospital
    Surabaya, East Java, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07266961
Lead sponsor
Dr. Soetomo General Hospital
Responsible party
Sponsor
First posted
Dec 5, 2025
Start date
Jun 1, 2023
Primary completion
Aug 31, 2023
Completion
Nov 30, 2023
Last update
Dec 5, 2025

Study contacts

Nuniek Nugraheni Sulistiawaty
principal investigator · Department of Physical Medicine and Rehabilitation - Dr. Soetomo Regional Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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