NCT07266961

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

October 1, 2025

Enrollment Period

3 months

First QC Date

November 25, 2025

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • VO₂max

    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 Outcomes (1)

  • BORG RPE Scale

    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.

Study Arms (2)

LIRT-BFR group

EXPERIMENTAL

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

MIRT group

ACTIVE COMPARATOR

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

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.

LIRT-BFR group

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.

MIRT group

Eligibility Criteria

Age60 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female aged ≥60 years who routinely performed aerobic exercise in RSUD Dr. Soetomo
  • Normal cognitive function (MoCA-Ina score ≥ 26)
  • Passed the screening questionnaire.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Surabaya, East Java, Indonesia

Location

Study Officials

  • Nuniek Nugraheni Sulistiawaty

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 5, 2025

Study Start

June 1, 2023

Primary Completion

August 31, 2023

Study Completion

November 30, 2023

Last Updated

December 5, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations