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Elastic-Band Resistance and Breathing Training for Older Adults With Pulmonary Function Impairment (EBBT-PFI)

30. června 2026 aktualizováno: Beijing Sport University

Effects of Elastic-Band Resistance Training With or Without Breathing Exercise on Pulmonary Function and Functional Performance in Community-Dwelling Older Adults With Pulmonary Function Impairment: A Randomized Controlled Trial

The goal of this clinical trial is to learn whether elastic-band resistance training, with or without breathing training, can improve lung function and physical function in older adults with pulmonary function impairment living in the community. It will also learn about the safety and feasibility of these exercise programs.

The main questions it aims to answer are:

Does elastic-band resistance training improve lung function, lower-limb muscle strength, walking ability, and exercise tolerance?

Does adding structured breathing training to elastic-band resistance training provide additional benefits for lung function and respiratory-related health status?

Are these exercise programs safe and acceptable for older adults in a community setting?

Researchers will compare three groups: elastic-band resistance training plus breathing training, elastic-band resistance training alone, and usual health education. This will help determine whether elastic-band resistance training is helpful and whether breathing training adds extra benefit.

Participants will:

Take part in a 12-week study

Be assigned by chance to one of three groups

Attend supervised exercise sessions 3 times per week if assigned to an exercise group

Receive usual health education and daily activity guidance

Complete lung function tests, muscle strength tests, physical function tests, and questionnaires at the start of the study, at 6 weeks, and at 12 weeks

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Detailed Description

Pulmonary function impairment is common in older adults and may be associated with reduced physical activity, lower exercise tolerance, poorer functional performance, and impaired respiratory-related health status. Community-dwelling older adults with early or mild pulmonary function decline may not receive formal pulmonary rehabilitation, but they may still benefit from simple, low-cost, and feasible exercise-based interventions.

This study was designed to evaluate whether a community-based elastic-band resistance training program, with or without structured breathing training, could improve pulmonary function and functional performance in older adults with pulmonary function impairment. Eligible participants were community-dwelling adults aged 60 years or older who were identified through pulmonary function screening. Participants were randomly assigned to one of three groups: elastic-band resistance training plus breathing training, elastic-band resistance training alone, or usual health education.

The elastic-band resistance training program used progressive resistance exercises targeting upper-limb, lower-limb, and trunk-related functional movement patterns. Training intensity was monitored using a perceived exertion scale and adjusted according to each participant's tolerance and movement quality. The structured breathing training program included breathing control exercises and breathing trainer-based practice, with progression based on training level, breath-holding or maintenance time, repetitions, and perceived breathing effort.

The intervention lasted 12 weeks. Participants in the exercise groups attended supervised sessions three times per week in a community health service setting, while the control group received usual health education and daily activity guidance. Study assessments were conducted at baseline, 6 weeks, and 12 weeks to examine changes in pulmonary function, muscle strength, functional performance, respiratory-related health status, sleep quality, adherence, and safety.

This study may provide evidence for a practical community-based exercise approach for older adults with pulmonary function impairment and may help clarify whether adding structured breathing training to elastic-band resistance training provides additional benefits.

Typ studie

Intervenční

Zápis (Odhadovaný)

75

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Beijing Municipality
      • Beijing, Beijing Municipality, Čína, 100084
        • Huayuan Road Community Health Service Center, Haidian District, Beijing
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age 60 to 85 years
  • Pulmonary function impairment identified by community-based spirometry screening
  • Community-dwelling older adults
  • Able to communicate and walk independently
  • Willing to participate in the 12-week intervention and all study assessments
  • Provided written informed consent

Exclusion Criteria:

  • Acute or unstable cardiovascular, respiratory, or severe musculoskeletal disease that made exercise training unsafe
  • Recent acute exacerbation, surgery, severe infection, or other health event that could affect safe participation
  • Significant cognitive impairment, communication disorder, or inability to cooperate with training or assessments
  • Currently receiving systematic pulmonary rehabilitation or regular structured exercise training that could affect the intervention effect
  • Unable to meet spirometry quality-control requirements
  • Unable to complete key baseline outcome assessments

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Usual Health Education
Participants in this arm did not receive systematic exercise training. They received usual health education and daily activity guidance, including general lifestyle advice, basic physical activity recommendations, and safety instructions. Participants completed the same study assessments at baseline, 6 weeks, and 12 weeks.
Experimentální: Elastic-Band Resistance Training Plus Breathing Training
Participants receive 12 weeks of supervised elastic-band resistance training combined with structured breathing training, in addition to usual health education. They attend 3-5 supervised sessions per week, with at least 3 sessions weekly. Each session includes approximately 60 minutes of elastic-band resistance training with warm-up, progressive exercises for the upper limbs, lower limbs, and trunk, and cool-down. Intensity is monitored using the OMNI-RES scale and adjusted according to movement quality and tolerance. An additional 10-minute breathing module includes inspiratory and expiratory trainer exercises, diaphragmatic breathing, pursed-lip breathing, rhythmic breathing, and breathing control. Participants also complete about 10 minutes of home-based breathing exercises on non-supervised days.
Behaviorální: Elastic-Band Resistance Training Plus Breathing Training
Supervised elastic-band resistance training plus structured breathing training is provided for 12 weeks in a community health service setting. Participants attend 3-5 supervised sessions per week, with at least 3 sessions weekly. Each session includes approximately 60 minutes of elastic-band resistance training, consisting of warm-up, progressive exercises for the upper limbs, lower limbs, and trunk, and cool-down. Intensity is monitored using the OMNI-RES scale and adjusted according to movement quality and tolerance. An additional 10-minute breathing module includes inspiratory and expiratory trainer exercises, diaphragmatic breathing, pursed-lip breathing, rhythmic breathing, and breathing control. Participants also complete about 10 minutes of home-based breathing exercises on non-supervised days. Usual health education is provided.
Behaviorální: Elastic-Band Resistance Training
Supervised elastic-band resistance training is provided for 12 weeks in a community health service setting. Participants attend 3-5 supervised sessions per week, with at least 3 sessions weekly. Each session lasts approximately 60 minutes and includes a warm-up, progressive elastic-band resistance exercises targeting the upper limbs, lower limbs, and trunk, and a cool-down. Training intensity is monitored using the OMNI-RES scale and adjusted according to movement quality and participant tolerance. Usual health education is also provided. No structured breathing training or home-based breathing exercises are included.
Aktivní komparátor: Elastic-Band Resistance Training
Participants receive 12 weeks of supervised elastic-band resistance training in addition to usual health education. They attend 3-5 supervised sessions per week, with at least 3 sessions weekly. Each session lasts approximately 60 minutes and includes a warm-up, progressive elastic-band resistance exercises targeting the upper limbs, lower limbs, and trunk, and a cool-down. Training intensity is monitored using the OMNI-RES scale and adjusted according to movement quality and participant tolerance. No structured breathing training or home-based breathing exercises are provided in this arm.
Behaviorální: Elastic-Band Resistance Training
Supervised elastic-band resistance training is provided for 12 weeks in a community health service setting. Participants attend 3-5 supervised sessions per week, with at least 3 sessions weekly. Each session lasts approximately 60 minutes and includes a warm-up, progressive elastic-band resistance exercises targeting the upper limbs, lower limbs, and trunk, and a cool-down. Training intensity is monitored using the OMNI-RES scale and adjusted according to movement quality and participant tolerance. Usual health education is also provided. No structured breathing training or home-based breathing exercises are included.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in FEV1 Z-Score From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
FEV1 z-score was calculated using reference equations to standardize pulmonary function according to age, sex, height, and ethnicity. The change from baseline to Week 12 was used to evaluate standardized improvement in pulmonary function. Higher z-scores indicate better lung function.
Baseline, Week 6, and Week 12
Change in FVC Z-Score From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
FVC z-score was calculated using reference equations to standardize pulmonary function according to age, sex, height, and ethnicity. The change from baseline to Week 12 was used to evaluate standardized improvement in pulmonary function. Higher z-scores indicate better lung function.
Baseline, Week 6, and Week 12
Change in FEV1/FVC Z-Score From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
FEV1/FVC z-score was calculated using reference equations to standardize the ratio according to age, sex, height, and ethnicity. The change from baseline to Week 12 was used to evaluate standardized change in airflow limitation. Higher z-scores indicate better pulmonary function.
Baseline, Week 6, and Week 12

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in FEV1/FVC Ratio From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
The FEV1/FVC ratio was calculated from standardized spirometry results. The change from baseline to Week 12 was used to evaluate airflow limitation. Higher values generally indicate better pulmonary function.
Baseline, Week 6, and Week 12
Change in Forced Expiratory Volume in 1 Second From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Forced expiratory volume in 1 second (FEV1) was measured using standardized spirometry. The change from baseline to Week 12 was used to evaluate improvement in pulmonary function. Higher values indicate better lung function.
Baseline, Week 6, and Week 12
Change in Forced Vital Capacity From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Forced vital capacity (FVC) was measured using standardized spirometry. The change from baseline to Week 12 was used to evaluate improvement in pulmonary function. Higher values indicate better lung function.
Baseline, Week 6, and Week 12
Change in 30-Second Chair Stand Test Performance From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
The 30-second chair stand test was used to assess repeated sit-to-stand ability. Participants were asked to complete as many full sit-to-stand repetitions as possible within 30 seconds. Higher values indicate better lower-limb functional performance.
Baseline, Week 6, and Week 12
Change in 4-Meter Gait Speed From Baseline to Week 12
Časové okno: The 4-meter gait speed test was used to assess usual walking ability. Participants walked a fixed 4-meter distance at their usual comfortable speed. Higher values indicate better walking performance.
Baseline, Week 6, and Week 12
The 4-meter gait speed test was used to assess usual walking ability. Participants walked a fixed 4-meter distance at their usual comfortable speed. Higher values indicate better walking performance.
Change in 2-Minute Step Test Performance From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
The 2-minute step test was used to assess short-duration exercise tolerance. Participants stepped in place for 2 minutes, and the number of valid steps reaching the required knee height was recorded. Higher values indicate better exercise tolerance.
Baseline, Week 6, and Week 12
Change in Dominant-Side Quadriceps Strength From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Dominant-side quadriceps strength was measured using a standardized muscle strength testing device. The change from baseline to Week 12 was used to evaluate lower-limb muscle strength. Higher values indicate greater muscle strength.
Baseline, Week 6, and Week 12
Change in Non-Dominant-Side Quadriceps Strength From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Non-dominant-side quadriceps strength was measured using a standardized muscle strength testing device. The change from baseline to Week 12 was used to evaluate lower-limb muscle strength. Higher values indicate greater muscle strength.
Baseline, Week 6, and Week 12
Change in Dominant-Side Triceps Surae Strength From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Dominant-side triceps surae strength was measured using a standardized muscle strength testing device. The change from baseline to Week 12 was used to evaluate lower-limb muscle strength. Higher values indicate greater muscle strength.
Baseline, Week 6, and Week 12
Change in Non-Dominant-Side Triceps Surae Strength From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Non-dominant-side triceps surae strength was measured using a standardized muscle strength testing device. The change from baseline to Week 12 was used to evaluate lower-limb muscle strength. Higher values indicate greater muscle strength.
Baseline, Week 6, and Week 12
Change in Timed Up and Go Test Performance From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
The Timed Up and Go test was used to assess functional mobility. Participants stood up from a chair, walked a fixed distance, turned around, returned to the chair, and sat down. Shorter completion time indicates better functional mobility.
Baseline, Week 6, and Week 12
Change in St. George's Respiratory Questionnaire Total Score From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Respiratory-related health status was assessed using the St. George's Respiratory Questionnaire total score. The change from baseline to Week 12 was used to evaluate respiratory symptoms and health-related quality of life. Lower scores indicate better respiratory-related health status.
Baseline, Week 6, and Week 12
Change in Pittsburgh Sleep Quality Index Total Score From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Sleep quality was assessed using the Pittsburgh Sleep Quality Index total score. The change from baseline to Week 12 was used to evaluate changes in subjective sleep quality. Lower scores indicate better sleep quality.
Baseline, Week 6, and Week 12

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Dominant-Side Handgrip Strength From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Dominant-side handgrip strength was measured using a standardized handgrip dynamometer. The change from baseline to Week 12 was used to evaluate upper-limb and overall muscle strength. Higher values indicate greater muscle strength.
Baseline, Week 6, and Week 12
Change in Non-Dominant-Side Handgrip Strength From Baseline to Week 12
Časové okno: Baseline, Week 6, and Week 12
Non-dominant-side handgrip strength was measured using a standardized handgrip dynamometer. The change from baseline to Week 12 was used to evaluate upper-limb and overall muscle strength. Higher values indicate greater muscle strength.
Baseline, Week 6, and Week 12
Intervention adherence
Časové okno: From the first training session to the end of the 12-week intervention
Percentage of prescribed training sessions completed during the 12-week intervention, calculated as the number of completed sessions divided by the number of prescribed sessions × 100. Higher values indicate greater adherence.
From the first training session to the end of the 12-week intervention
Total training time
Časové okno: From the first training session to the end of the 12-week intervention
Cumulative duration of completed supervised and home-based training sessions during the 12-week intervention, calculated from attendance records and training logs.
From the first training session to the end of the 12-week intervention
Participant retention rate
Časové okno: From randomization to the Week 12 follow-up assessment
Percentage of randomized participants who completed the Week 12 follow-up assessment, calculated as the number completing the assessment divided by the number randomized to each group × 100.
From randomization to the Week 12 follow-up assessment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Beijing Sport University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

10. června 2026

Primární dokončení (Odhadovaný)

15. září 2026

Dokončení studie (Odhadovaný)

16. září 2026

Termíny zápisu do studia

První předloženo

21. května 2026

První předloženo, které splnilo kritéria kontroly kvality

21. května 2026

První zveřejněno (Aktuální)

28. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BeijingSU

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared because the study involves health-related data from older adults, and public sharing was not specified in the informed consent or ethics approval. De-identified data may be considered only upon reasonable request and with appropriate ethical approval.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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