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

NCT07573995 | Not Yet Recruiting

• 1 other identifier: 2025-UAAT-UTS02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

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

  T0 = baseline; T1 = immediately after intervention

• 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.

  T0 = baseline; T1 = immediately after intervention

• 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)

  T0 = baseline; T1 = immediately after intervention

• 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.

  T0 = baseline; T1 = immediately after intervention

• 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.

  T0 = baseline; T1 = immediately after intervention

• 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

  T0 = baseline; T1 = immediately after intervention

Secondary Outcomes (8)

• Respiratory Muscle Strength

  T0 = baseline; T1 = immediately after intervention

• Handgrip Strength

  T0 = baseline; T1 = immediately after intervention

• Five-times sit-to-stand

  T0 = baseline; T1 = immediately after intervention

• Frailty level

  T0 = baseline; T1 = immediately after intervention

• Fall Efficacy

  T0 = baseline; T1 = immediately after intervention

Other Outcomes (2)

• The Borg Rating of Perceived Exertion (RPE) Scale

  T0 = baseline; T1 = immediately after intervention

• Automated Office Blood Pressure

  T0 = baseline; T1 = immediately after intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the experimental group will receive a 6 week combined BFR and IMT intervention

Behavioral: Exercise

Control group

SHAM COMPARATOR

Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.

Behavioral: Sham Control

Interventions

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.

Intervention group

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

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Taipei Medical University: lead
• National Taiwan University: collaborator
• The University of Texas at Austin: collaborator

Study Sites (1)

Taipei Medical University

Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Pei-Shan Tsai Professor, PhD

CONTACT

+886227361661; ptsai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: We will implement a double-masking protocol, ensuring that participants and outcome assessors are all blinded to group assignments. Additionally, group assignments will also be masked from the data analyzer to minimize potential bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)