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NCT Number: NCT07573995

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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

Behavioral

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 outcomes

  1. Recruitment rate

    Time frame: 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

  2. Attrition rate

    Time frame: 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.

  3. Exercise Enjoyment

    Time frame: 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)

  4. Short Physical Performance Battery (SPPB)

    Time frame: 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.

  5. 6-Minute Walk Test (6MWT)

    Time frame: 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.

  6. Time Up to Go (TUG)

    Time frame: 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

Secondary outcomes

  1. Respiratory Muscle Strength

    Time frame: T0 = baseline; T1 = immediately after intervention

    We will use the S-Index Test to evaluate the respiratory muscle function based on maximum dynamic inspiratory pressure, which is a recommended tool developed by POWERbreathe. Participants will be advised to avoid strenuous exercise for 24h and to rest in a sitting position for 15 minutes before the assessment. Then, they performed eight inspiratory maneuvers in a standing position, divided into three to four series of two to three repetitions.

  2. Handgrip Strength

    Time frame: T0 = baseline; T1 = immediately after intervention

    Handgrip strength will be evaluated to estimate the maximum upper-limb muscle function in older adults. Participants will be seated with the shoulder adducted, the elbow flexed to 90°, and the forearm and wrist in a neutral position. They will then be instructed to squeeze the dynamometer as forcefully as possible.

  3. Five-times sit-to-stand

    Time frame: T0 = baseline; T1 = immediately after intervention

    The five-times sit-to-stand test is simple to administer and has been widely applied in both clinical and research settings. Participants will sit with their backs against the chair and be instructed to stand and sit five times as quickly as possible.

  4. Frailty level

    Time frame: T0 = baseline; T1 = immediately after intervention

    The Clinical Frailty Scale (CFS) is a 9-point global clinical measure ranging from 1 (very fit) to 9 (terminally ill), used to classify frailty severity in older adults. A traditional Chinese version of the CFS has been validated in Taiwanese older adults, demonstrating acceptable inter-rater reliability and good criterion validity against established frailty measures

  5. Fall Efficacy

    Time frame: T0 = baseline; T1 = immediately after intervention

    The short form of the Falls Efficacy Scale-International (FES-I) includes 7 items rated on a 4-point Likert scale from 1 (not at all concerned) to 4 (very concerned). The total score ranges from 7 to 28, with higher values indicating greater concern about falling

  6. Adverse events

    Time frame: T0 = baseline; T1 = immediately after intervention

    The study team will record adverse events during the intervention caused by the exercise, including falls, fractures, exercise-related pain, dizziness, muscle strain, sprains, respiratory and cardiac adverse events, and hospitalization.

  7. Fat mass

    Time frame: T0 = baseline; T1 = immediately after intervention

    Fat mass will be assessed using a body composition analyzer and recorded in kilograms

  8. Fat-free mass

    Time frame: T0 = baseline; T1 = immediately after intervention

    Fat-free mass will be assessed using a body composition analyzer and recorded in kilograms.

Other outcomes

  1. The Borg Rating of Perceived Exertion (RPE) Scale

    Time frame: T0 = baseline; T1 = immediately after intervention

    The Borg RPE scale reflects an individual's subjective perception of exercise intensity, integrating sensations of physical effort, breathlessness, and fatigue. The scale ranges from 6 to 20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion." This RPE score will be assessed every training session

  2. Automated Office Blood Pressure

    Time frame: T0 = baseline; T1 = immediately after intervention

    Automated Office Blood Pressure will be monitored before and after intervention to minimize cardiovascular risks and ensure that timely medical assistance is available for participants who experience any discomfort. Upon arrival at the lab, participants will be asked to sit for at least 5 minutes before the first blood pressure reading; the average of two readings will be used for that visit

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Shan Tsai Professor, PhD

CONTACT

[email protected]

+886227361661 ext. 6321

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • National Taiwan University
  • The University of Texas at Austin

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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