Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

1. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Pei-Shan Tsai Professor, PhD
  • Telefonnummer: 6321 +886227361661
  • E-Mail: ptsai@tmu.edu.tw

Studienorte

  • Taiwan
      • Taipei, Taiwan, 11031
        • Taipei Medical University
        • Kontakt:
          • Pei-Shan Tsai Professor, PhD
          • Telefonnummer: 6321 +886227361661
          • E-Mail: ptsai@tmu.edu.tw

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention group
Participants in the experimental group will receive a 6 week combined BFR and IMT intervention
Verhalten: 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.
Schein-Komparator: Control group
Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.
Verhalten: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Respiratory Muscle Strength
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The Borg Rating of Perceived Exertion (RPE) Scale
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Taipei Medical University

Mitarbeiter

National Taiwan University
The University of Texas at Austin

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2026

Studienabschluss (Geschätzt)

1. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

23. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Mai 2026

Zuerst gepostet (Tatsächlich)

7. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025-UAAT-UTS02

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Ältere Erwachsene

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Argentina

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren