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

2026년 5월 1일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Pei-Shan Tsai Professor, PhD
전화번호: 6321 +886227361661
이메일: ptsai@tmu.edu.tw

연구 장소

대만
- - Taipei, 대만, 11031
    - Taipei Medical University
    - 연락하다:
      
      Pei-Shan Tsai Professor, PhD
      
      전화번호: 6321 +886227361661
      
      이메일: ptsai@tmu.edu.tw

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 더블

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: Intervention group Participants in the experimental group will receive a 6 week combined BFR and IMT intervention	행동: 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.
가짜 비교기: Control group Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.	행동: 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

참가자 그룹 / 팔

개입 / 치료

실험적: Intervention group

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

행동: 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.

가짜 비교기: Control group

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

행동: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Recruitment rate 기간: 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 기간: 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 기간: 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) 기간: 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) 기간: 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) 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Respiratory Muscle Strength 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

기타 결과 측정

결과 측정	측정값 설명	기간
The Borg Rating of Perceived Exertion (RPE) Scale 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Taipei Medical University

협력자

National Taiwan University

The University of Texas at Austin

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 1일

기본 완료 (추정된)

2026년 10월 1일

연구 완료 (추정된)

2026년 10월 1일

연구 등록 날짜

최초 제출

2026년 4월 23일

QC 기준을 충족하는 최초 제출

2026년 5월 1일

처음 게시됨 (실제)

2026년 5월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 1일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

2025-UAAT-UTS02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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이집트

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