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NCT Number: NCT07266961

Low-BFR vs 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.

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Key information

Conditions

Cardiorespiratory Fitness

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation - Dr. Soetomo Regional Hospital

Surabaya, East Java, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Intensity Resistance Training and Blood Flow Resistance

Other

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.

Moderate Intensity Resistance Training

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dr. Soetomo General Hospital

Other Gov

Registry information

Official study title

The Effects of Low-Intensity Resistance Training Combined With Blood Flow Restriction Versus Moderate-Intensity Resistance Training on Cardiorespiratory Fitness in Elderly Women

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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