About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60 to 85 years
Pulmonary function impairment identified by community-based spirometry screening
Community-dwelling older adults
Able to communicate and walk independently
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Elastic-Band Resistance Training Plus Breathing Training
BehavioralSupervised 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.
Elastic-Band Resistance Training
BehavioralSupervised 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in FEV1 Z-Score From Baseline to 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.
Change in FVC Z-Score From Baseline to 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.
Change in FEV1/FVC Z-Score From Baseline to 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.
Secondary outcomes
Change in Dominant-Side Quadriceps Strength From Baseline to 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.
Change in Forced Vital Capacity From Baseline to 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.
Change in Forced Expiratory Volume in 1 Second From Baseline to 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.
Change in FEV1/FVC Ratio From Baseline to 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.
Other outcomes
Change in Dominant-Side Handgrip Strength From Baseline to 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.
Change in Non-Dominant-Side Handgrip Strength From Baseline to 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.
Intervention adherence
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.
Total training time
Cumulative duration of completed supervised and home-based training sessions during the 12-week intervention, calculated from attendance records and training logs.
Sponsors and contacts
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