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

30 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

75

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100084
        • Huayuan Road Community Health Service Center, Haidian District, Beijing
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.
Comportamentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in FEV1 Z-Score From Baseline to Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in FEV1/FVC Ratio From Baseline to Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Dominant-Side Handgrip Strength From Baseline to Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing Sport University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 giugno 2026

Completamento primario (Stimato)

15 settembre 2026

Completamento dello studio (Stimato)

16 settembre 2026

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BeijingSU

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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