Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise, Sham Control.
- Who it may be relevant to
- Registry conditions: Frailty Syndrome, Older Adults, Blood Flow Restriction (BFR) Training Effects, Inspiratory Muscle Training. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults: A Pilot Randomized Controlled Trial
Overview
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.
Detailed description
This is a parallel randomized controlled trial. 30 participants who are older adults with frailty will be enrolled.
Eligible participants who complete the baseline measurements will be randomly allocated to a combined BFR and IMT intervention group (N=15) or in the control group with BFR and sham IMT (N=15).
Primary outcomes include feasibility and physical function (i.e., the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), and Time Up and Go (TUG) test). Secondary outcomes include respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events. All outcomes will be assessed at baseline (T0) and immediately after the 6-week intervention period (T1) in both groups.
Interventions
- Behavioral Exercise
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 - Behavioral Sham Control
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
Primary outcome measures
- Recruitment rate [Time frame: T0 = baseline; T1 = immediately after intervention]
- Attrition rate [Time frame: T0 = baseline; T1 = immediately after intervention]
- Exercise Enjoyment [Time frame: T0 = baseline; T1 = immediately after intervention]
- Short Physical Performance Battery (SPPB) [Time frame: T0 = baseline; T1 = immediately after intervention]
- 6-Minute Walk Test (6MWT) [Time frame: T0 = baseline; T1 = immediately after intervention]
- Time Up to Go (TUG) [Time frame: T0 = baseline; T1 = immediately after intervention]
Secondary outcome measures (8)
- Respiratory Muscle Strength [Time frame: T0 = baseline; T1 = immediately after intervention]
- Handgrip Strength [Time frame: T0 = baseline; T1 = immediately after intervention]
- Five-times sit-to-stand [Time frame: T0 = baseline; T1 = immediately after intervention]
- Frailty level [Time frame: T0 = baseline; T1 = immediately after intervention]
- Fall Efficacy [Time frame: T0 = baseline; T1 = immediately after intervention]
- Adverse events [Time frame: T0 = baseline; T1 = immediately after intervention]
- Fat mass [Time frame: T0 = baseline; T1 = immediately after intervention]
- Fat-free mass [Time frame: T0 = baseline; T1 = immediately after intervention]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Medical University — Taipei
Identifiers
NCT: NCT07573995 · 2025-UAAT-UTS02