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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 allow participants to become familiar with the technique. The intensity will gradually increase to a target of 60% MIP by Week 6, based on the participants' tolerance. For the BFR, during weeks 1-2, participants will train at constant loads. From weeks 2-6, training loads will be increased. Cuff pressure will be prescribed relative to the calculated arterial occlusion pressure (AOP): 50% in weeks 1-2, 60% in weeks 3-4, and 70% in weeks 5-6 for both lower- and upper-body exercises.

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

Study 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.

Eligibility

Primary outcome measure(s)

• Recruitment rate — T0 = baseline; T1 = immediately after intervention
  The recruitment rate will be calculated by dividing the number of recruited participants by the number of eligible participants
• Attrition rate — T0 = baseline; T1 = immediately after intervention
  Attrition rate is the proportion of randomized participants who withdraw from the study or are lost to follow-up before completing the final assessment.
• Exercise Enjoyment — T0 = baseline; T1 = immediately after intervention
  Enjoyment will be assessed using a single-item Exercise Enjoyment Scale, which asks participants, "How much did you enjoy the exercise session?). Responses are rated on a 7 Likert scale ranging from 1 (not at all) to 7 (extremely)
• Short Physical Performance Battery (SPPB) — T0 = baseline; T1 = immediately after intervention
  The SPPB consists of three components-standing balance, gait speed, and repeated chair stands-each scored from 0 to 4 and summed to a total score ranging from 0 (worst performance) to 12 (best performance). Lower SPPB scores indicate poorer physical function and a higher risk of adverse outcomes, with scores below 10 predictive of all-cause mortality in older adults.
• 6-Minute Walk Test (6MWT) — T0 = baseline; T1 = immediately after intervention
  The 6MWT will be used to assess functional exercise capacity. Participants will be instructed to walk as far as possible along a flat, straight course for 6 minutes, and the total distance is recorded.
• Time Up to Go (TUG) — T0 = baseline; T1 = immediately after intervention
  The TUG test is used to assess functional mobility, balance, and fall risk in older adults, incorporating a series of dynamic activities. Participants will be instructed to rise from a chair, walk three meters at a comfortable pace, turn around, walk back to the chair, and sit down. The total time taken to complete the task is recorded, with longer times indicating poorer functional mobility and higher fall risk

Trial sites (1)

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