Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
19 augustus 2026 bijgewerkt door: Pei-Shan, Tsai, Taipei Medical University
Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults: A Pilot Randomized Controlled Trial
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
30
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Pei-Shan Tsai Professor, PhD
- Telefoonnummer: 6321 +886227361661
- E-mail: ptsai@tmu.edu.tw
Studie Locaties
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Taipei, Taiwan, 11031
- Taipei Medical University
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Contact:
- Pei-Shan Tsai Professor, PhD
- Telefoonnummer: 6321 +886227361661
- E-mail: ptsai@tmu.edu.tw
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Intervention group
Participants in the experimental group will receive a 6 week combined BFR and IMT intervention
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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. |
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Sham-vergelijker: Control group
Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.
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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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Recruitment rate
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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The recruitment rate will be calculated by dividing the number of recruited participants by the number of eligible participants
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T0 = baseline; T1 = immediately after intervention
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Attrition rate
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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Attrition rate is the proportion of randomized participants who withdraw from the study or are lost to follow-up before completing the final assessment.
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T0 = baseline; T1 = immediately after intervention
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Exercise Enjoyment
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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)
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T0 = baseline; T1 = immediately after intervention
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Short Physical Performance Battery (SPPB)
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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.
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T0 = baseline; T1 = immediately after intervention
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6-Minute Walk Test (6MWT)
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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.
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T0 = baseline; T1 = immediately after intervention
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Time Up to Go (TUG)
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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
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T0 = baseline; T1 = immediately after intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Respiratory Muscle Strength
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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.
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T0 = baseline; T1 = immediately after intervention
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Handgrip Strength
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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.
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T0 = baseline; T1 = immediately after intervention
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Five-times sit-to-stand
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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.
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T0 = baseline; T1 = immediately after intervention
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Frailty level
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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
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T0 = baseline; T1 = immediately after intervention
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Fall Efficacy
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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
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T0 = baseline; T1 = immediately after intervention
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Adverse events
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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.
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T0 = baseline; T1 = immediately after intervention
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Fat mass
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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Fat mass will be assessed using a body composition analyzer and recorded in kilograms
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T0 = baseline; T1 = immediately after intervention
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Fat-free mass
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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Fat-free mass will be assessed using a body composition analyzer and recorded in kilograms.
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T0 = baseline; T1 = immediately after intervention
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The Borg Rating of Perceived Exertion (RPE) Scale
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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
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T0 = baseline; T1 = immediately after intervention
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Automated Office Blood Pressure
Tijdsspanne: T0 = baseline; T1 = immediately after intervention
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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
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T0 = baseline; T1 = immediately after intervention
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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
30 juli 2026
Primaire voltooiing (Geschat)
31 juli 2027
Studie voltooiing (Geschat)
31 juli 2027
Studieregistratiedata
Eerst ingediend
23 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 mei 2026
Eerst geplaatst (Werkelijk)
7 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
19 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025-UAAT-UTS02
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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