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

1 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Pei-Shan Tsai Professor, PhD
Numero di telefono: 6321 +886227361661
Email: ptsai@tmu.edu.tw

Luoghi di studio

Taiwan
- - Taipei, Taiwan, 11031
    - Taipei Medical University
    - Contatto:
      
      Pei-Shan Tsai Professor, PhD
      
      Numero di telefono: 6321 +886227361661
      
      Email: ptsai@tmu.edu.tw

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto più anziano

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Doppio

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: Intervention group Participants in the experimental group will receive a 6 week combined BFR and IMT intervention	Comportamentale: 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.
Comparatore fittizio: Control group Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.	Comportamentale: 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

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: Intervention group

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

Comportamentale: 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.

Comparatore fittizio: Control group

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

Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Recruitment rate Lasso di tempo: 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	T0 = baseline; T1 = immediately after intervention
Attrition rate Lasso di tempo: 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.	T0 = baseline; T1 = immediately after intervention
Exercise Enjoyment Lasso di tempo: 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)	T0 = baseline; T1 = immediately after intervention
Short Physical Performance Battery (SPPB) Lasso di tempo: 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.	T0 = baseline; T1 = immediately after intervention
6-Minute Walk Test (6MWT) Lasso di tempo: 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.	T0 = baseline; T1 = immediately after intervention
Time Up to Go (TUG) Lasso di tempo: 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	T0 = baseline; T1 = immediately after intervention

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Respiratory Muscle Strength Lasso di tempo: 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.	T0 = baseline; T1 = immediately after intervention
Handgrip Strength Lasso di tempo: 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.	T0 = baseline; T1 = immediately after intervention
Five-times sit-to-stand Lasso di tempo: 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.	T0 = baseline; T1 = immediately after intervention
Frailty level Lasso di tempo: 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	T0 = baseline; T1 = immediately after intervention
Fall Efficacy Lasso di tempo: 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	T0 = baseline; T1 = immediately after intervention
Adverse events Lasso di tempo: 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.	T0 = baseline; T1 = immediately after intervention
Fat mass Lasso di tempo: T0 = baseline; T1 = immediately after intervention	Fat mass will be assessed using a body composition analyzer and recorded in kilograms	T0 = baseline; T1 = immediately after intervention
Fat-free mass Lasso di tempo: T0 = baseline; T1 = immediately after intervention	Fat-free mass will be assessed using a body composition analyzer and recorded in kilograms.	T0 = baseline; T1 = immediately after intervention

Altre misure di risultato

Misura del risultato	Misura Descrizione	Lasso di tempo
The Borg Rating of Perceived Exertion (RPE) Scale Lasso di tempo: 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	T0 = baseline; T1 = immediately after intervention
Automated Office Blood Pressure Lasso di tempo: 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	T0 = baseline; T1 = immediately after intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Taipei Medical University

Collaboratori

National Taiwan University

The University of Texas at Austin

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

23 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 maggio 2026

Primo Inserito (Effettivo)

7 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

2025-UAAT-UTS02

Piano per i dati dei singoli partecipanti (IPD)

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Informazioni su farmaci e dispositivi, documenti di studio

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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Svezia

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