Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
2026. augusztus 19. frissítette: 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.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
30
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Pei-Shan Tsai Professor, PhD
- Telefonszám: 6321 +886227361661
- E-mail: ptsai@tmu.edu.tw
Tanulmányi helyek
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Taipei, Tajvan, 11031
- Taipei Medical University
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Kapcsolatba lépni:
- Pei-Shan Tsai Professor, PhD
- Telefonszám: 6321 +886227361661
- E-mail: ptsai@tmu.edu.tw
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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 Comparator: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Recruitment rate
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Respiratory Muscle Strength
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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The Borg Rating of Perceived Exertion (RPE) Scale
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. július 30.
Elsődleges befejezés (Becsült)
2027. július 31.
A tanulmány befejezése (Becsült)
2027. július 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. április 23.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 1.
Első közzététel (Tényleges)
2026. május 7.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. augusztus 21.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 19.
Utolsó ellenőrzés
2026. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2025-UAAT-UTS02
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
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