Elastic-Band Resistance and Breathing Training for Older Adults With Pulmonary Function Impairment (EBBT-PFI)
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chuyuan Qiao, Master
- Número de teléfono: +86-13801107617
- Correo electrónico: xiaosadashuai@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100084
- Huayuan Road Community Health Service Center, Haidian District, Beijing
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Contacto:
- Yan Wang, Doctor
- Número de teléfono: +86-15201061266
- Correo electrónico: wyweiwei@126.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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.
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Comparador activo: 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.
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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.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in FEV1/FVC Ratio From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Forced Expiratory Volume in 1 Second From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Forced Vital Capacity From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in FEV1 Z-Score From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in FVC Z-Score From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in FEV1/FVC Z-Score From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in 30-Second Chair Stand Test Performance From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in 4-Meter Gait Speed From Baseline to Week 12
Periodo de tiempo: 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.
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Baseline, Week 6, and Week 12
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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.
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Change in 2-Minute Step Test Performance From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Dominant-Side Quadriceps Strength From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Non-Dominant-Side Quadriceps Strength From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Dominant-Side Triceps Surae Strength From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Non-Dominant-Side Triceps Surae Strength From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Timed Up and Go Test Performance From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Dominant-Side Handgrip Strength From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Non-Dominant-Side Handgrip Strength From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in St. George's Respiratory Questionnaire Total Score From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Pittsburgh Sleep Quality Index Total Score From Baseline to Week 12
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última verificación
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Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BeijingSU
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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