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

2026年5月1日更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

段階

適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Pei-Shan Tsai Professor, PhD
電話番号：6321 +886227361661
メール：ptsai@tmu.edu.tw

研究場所

台湾
- - Taipei、台湾、11031
    - Taipei Medical University
    - コンタクト：
      
      Pei-Shan Tsai Professor, PhD
      
      電話番号：6321 +886227361661
      
      メール：ptsai@tmu.edu.tw

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：処理
割り当て：ランダム化
介入モデル：並列代入
マスキング：ダブル

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：Intervention group Participants in the experimental group will receive a 6 week combined BFR and IMT intervention	行動：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.
偽コンパレータ：Control group Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.	行動：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

参加者グループ / アーム

介入・治療

実験的：Intervention group

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

行動：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.

偽コンパレータ：Control group

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

行動：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

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Recruitment rate 時間枠：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 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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) 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Respiratory Muscle Strength 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

その他の成果指標

結果測定	メジャーの説明	時間枠
The Borg Rating of Perceived Exertion (RPE) Scale 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Taipei Medical University

協力者

National Taiwan University

The University of Texas at Austin

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月1日

一次修了 (推定)

2026年10月1日

研究の完了 (推定)

2026年10月1日

試験登録日

最初に提出

2026年4月23日

QC基準を満たした最初の提出物

2026年5月1日

最初の投稿 (実際)

2026年5月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月7日

QC基準を満たした最後の更新が送信されました

2026年5月1日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

2025-UAAT-UTS02

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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