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

21 maja 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

75

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Elastic-Band Resistance Training Plus Breathing Training
Participants in this arm received supervised elastic-band resistance training combined with structured breathing training for 12 weeks, in addition to usual health education. The elastic-band resistance training was performed 3 times per week and included warm-up, progressive resistance exercises targeting upper-limb, lower-limb, and trunk-related functional movements, and cool-down. Training intensity was monitored using the OMNI-RES perceived exertion scale and adjusted according to movement quality and participant tolerance. The breathing training included breathing trainer-based practice, diaphragmatic breathing, pursed-lip breathing, rhythmic breathing, and breathing control exercises. Participants also received daily activity guidance and health education.
Behawioralne: Elastic-Band Resistance Training Plus Breathing Training
Supervised elastic-band resistance training plus structured breathing training for 12 weeks. Participants trained 3 times per week in a community health service setting. Resistance training included warm-up, progressive elastic-band exercises, and cool-down, targeting upper-limb, lower-limb, and trunk-related functional movements. Intensity was monitored using the OMNI-RES scale and adjusted according to tolerance and movement quality. Breathing training included breathing trainer practice, diaphragmatic breathing, pursed-lip breathing, rhythmic breathing, and breathing control. Usual health education was also provided.
Behawioralne: Elastic-Band Resistance Training
Supervised elastic-band resistance training for 12 weeks. Participants trained 3 times per week in a community health service setting. Each session included warm-up, progressive elastic-band resistance exercises, and cool-down. Exercises targeted upper-limb, lower-limb, and trunk-related functional movements. Intensity was monitored using the OMNI-RES scale and adjusted according to tolerance and movement quality. Usual health education was also provided. No structured breathing training was provided.
Aktywny komparator: Elastic-Band Resistance Training
Participants in this arm received supervised elastic-band resistance training for 12 weeks, in addition to usual health education. The training was performed 3 times per week and included warm-up, progressive elastic-band resistance exercises, and cool-down. Exercises targeted upper-limb, lower-limb, and trunk-related functional movement patterns. Training intensity was monitored using the OMNI-RES perceived exertion scale and adjusted according to participant tolerance and movement quality. No structured breathing training was provided in this arm.
Behawioralne: Elastic-Band Resistance Training
Supervised elastic-band resistance training for 12 weeks. Participants trained 3 times per week in a community health service setting. Each session included warm-up, progressive elastic-band resistance exercises, and cool-down. Exercises targeted upper-limb, lower-limb, and trunk-related functional movements. Intensity was monitored using the OMNI-RES scale and adjusted according to tolerance and movement quality. Usual health education was also provided. No structured breathing training was provided.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in FEV1/FVC Ratio From Baseline to Week 12
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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 FEV1 Z-Score From Baseline to Week 12
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Change in 30-Second Chair Stand Test Performance From Baseline to Week 12
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Dominant-Side Quadriceps Strength From Baseline to Week 12
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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 Dominant-Side Handgrip Strength From Baseline to Week 12
Ramy czasowe: 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
Ramy czasowe: 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
Change in St. George's Respiratory Questionnaire Total Score From Baseline to Week 12
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Beijing Sport University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

10 czerwca 2026

Zakończenie podstawowe (Szacowany)

15 września 2026

Ukończenie studiów (Szacowany)

16 września 2026

Daty rejestracji na studia

Pierwszy przesłany

21 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 maja 2026

Pierwszy wysłany (Rzeczywisty)

28 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • BeijingSU

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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