Combined inspiratory muscle training with blood flow restriction for frail older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-group trial will enroll 30 community-dwelling adults aged 65 or older who are frail or vulnerable. Participants will be randomly assigned to either a combined inspiratory muscle training with blood flow restriction or a sham IMT with the same BFR setup for six weeks. Primary outcomes focus on feasibility and physical function measures such as SPPB, 6-minute walk, and Timed Up and Go, assessed at baseline and after the intervention. Secondary outcomes include respiratory and handgrip strength, five-times sit-to-stand, body composition, frailty level, fall efficacy, blood pressure, and adverse events. The study is led by Taipei Medical University with collaboration from National Taiwan University and University of Texas at Austin.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taipei Medical University
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Pei-Shan Tsai Professor, PhD
• Email: ptsai@tmu.edu.tw
• Phone: +886227361661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.