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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorTaipei Medical University

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

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Taipei Medical University

Lead sponsor

National Taiwan University

Collaborator

The University of Texas at Austin

Collaborator