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Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults

Sponsor: Taipei Medical University • ClinicalTrials.gov ID: NCT07573995

Registry updated: 2026-10-05

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Description

This randomized controlled trial study aims to evaluate the feasibility and preliminary efficacy of a combined inspiratory muscle training (IMT) and blood flow restriction (BFR) intervention in frail older adults. Outcomes of interest include feasibility, physical function, respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events.

Interventions

Exercise (Behavioral)
Each session will last approximately 60 minutes and will include three components: (1) an initial 3-minute IMT exercise performed at an intensity corresponding to rating of perceived exertion (RPE) 11-13 on the Borg 6-20 scale, (2) a 50-minute low-intensity exercise program combined with BFR, and (3) a second 3-minute IMT session at the same target intensity. For the IMT, the protocol follows a progressive intensity model, starting with 30% of the maximum inspiratory pressure (MIP) in Week 1 to allow participants to become familiar with the technique. The intensity will gradually increase to a target of 60% MIP by Week 6, based on the participants' tolerance. For the BFR, during weeks 1-2, participants will train at constant loads. From weeks 2-6, training loads will be increased. Cuff pressure will be prescribed relative to the calculated arterial occlusion pressure (AOP): 50% in weeks 1-2, 60% in weeks 3-4, and 70% in weeks 5-6 for both lower- and upper-body exercises.
Sham Control (Behavioral)
Participants in the control group will perform the identical BFR exercise protocol as the intervention group. However, IMT will be delivered at 2% of MIP, which is considered a sham condition and has not been shown to improve respiratory muscle function. If the calculated load corresponding to 2% of a participant's baseline S-Index is below the minimum resistance permitted by the POWERbreathe K5, the device's minimum available load of 5 cmH₂O will be applied.

Eligibility criteria

Inclusion Criteria: * Community-dwelling adults aged 65 years and older who are classified as at least "vulnerable" using the Clinical Frailty Scale (score ≥4). * Participants must have no cognitive impairment and be able to follow commands, as assessed by the Mini-Mental State Examination (MMSE). Exclusion Criteria: * (1) are unable to participate in exercise (e.g., due to severe musculoskeletal disorders) * (2) have high-risk factors for exercise, such as uncontrolled hypertension (\>150 mmHg systolic blood pressure (SBP) / \>90 mmHg diastolic blood pressure (DBP), coagulation disorders, and deep venous thrombosis * (3) have hematological disorders or are using hematology related-medications * (4) have significant comorbidities, including a history of stroke, diabetes with severe complications, or cardiovascular diseases * (5) chronic lung conditions (e.g., obstructive pulmonary disease, asthma), and * (6) have participated in a structured exercise training program within the past 3 months at a frequency exceeding three sessions per week.

Conditions

Frailty Syndrome Older Adults Blood Flow Restriction (BFR) Training Effects Inspiratory Muscle Training

Locations

Taipei Medical University — Taipei, Taiwan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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