About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
(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
Trial design
Treatments tested in this trial
- Exercise
- Sham Control
Treatment groups
Sponsors and collaborators
Taipei Medical University
Lead sponsor
National Taiwan University
Collaborator
The University of Texas at Austin
Collaborator