Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for F… (NCT07573995) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
Taiwan30 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment rate
Timeframe: T0 = baseline; T1 = immediately after intervention
2
Attrition rate
Timeframe: T0 = baseline; T1 = immediately after intervention
3
Exercise Enjoyment
Timeframe: T0 = baseline; T1 = immediately after intervention
4
Short Physical Performance Battery (SPPB)
Timeframe: T0 = baseline; T1 = immediately after intervention
5
6-Minute Walk Test (6MWT)
Timeframe: T0 = baseline; T1 = immediately after intervention
6
Time Up to Go (TUG)
Timeframe: T0 = baseline; T1 = immediately after intervention