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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 65 years and older
• All sexes
• No healthy volunteers
• Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults: A Pilot Randomized Controlled Trial

Conditions

Frailty Syndrome, Older Adults, Blood Flow Restriction (BFR) Training Effects, Inspiratory Muscle Training

Being tested

Exercise, Sham Control

Keywords

frailty, older adults, blood flow restriction, inspiratory muscle training

Medical subject headings

Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ExerciseBehavioural

  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 ControlBehavioural

  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. If the calculated load corresponding to 2% of a participant's baseline S-Index is below the minimum resistance permitted by the POWERbreathe K5, the device's minimum available load of 5 cmH₂O will be applied.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Recruitment rate

   The recruitment rate will be calculated by dividing the number of recruited participants by the number of eligible participants

   Measured: T0 = baseline; T1 = immediately after intervention

2. Attrition rate

   Attrition rate is the proportion of randomized participants who withdraw from the study or are lost to follow-up before completing the final assessment.

   Measured: T0 = baseline; T1 = immediately after intervention

3. Exercise Enjoyment

   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)

   Measured: T0 = baseline; T1 = immediately after intervention

4. Short Physical Performance Battery (SPPB)

   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.

   Measured: T0 = baseline; T1 = immediately after intervention

5. 6-Minute Walk Test (6MWT)

   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.

   Measured: T0 = baseline; T1 = immediately after intervention

6. Time Up to Go (TUG)

   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

   Measured: T0 = baseline; T1 = immediately after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted7 May 2026
2. Study start19 Aug 2026
3. Primary completion31 Jul 2027 (estimated)
4. Study completion31 Jul 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Frailty SyndromeStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.