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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastic-Band Resistance Training Plus Breathing Training | Experimental | 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. |
|
| Elastic-Band Resistance Training | Active Comparator | 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. |
|
| Usual Health Education | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elastic-Band Resistance Training Plus Breathing Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6, and Week 12 |
| 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. | Baseline, Week 6, and Week 12 |
| 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. | Baseline, Week 6, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6, and Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuyuan Qiao, Master | Contact | +86-13801107617 | xiaosadashuai@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huayuan Road Community Health Service Center, Haidian District, Beijing | Beijing | Beijing Municipality | 100084 | China |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2025 | May 21, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2025 | May 21, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: elastic-band resistance training plus breathing training, elastic-band resistance training alone, or usual health education.
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Because of the nature of the exercise intervention, participants and intervention providers were not masked to group allocation. Outcome assessors were masked to group assignment during follow-up assessments. Data analysts used coded group labels during the main statistical analysis whenever possible. Participants were instructed not to disclose their group assignment to the assessors.
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| Elastic-Band Resistance Training | Behavioral | 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. |
|
| 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. |
| Baseline, Week 6, and Week 12 |
| 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. | Baseline, Week 6, and Week 12 |
| 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. | Baseline, Week 6, and Week 12 |
| Change in Non-Dominant-Side Quadriceps Strength From Baseline to 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 | 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 | 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 | 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 2-Minute Step Test Performance From Baseline to 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 4-Meter Gait Speed From Baseline to Week 12 | 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 30-Second Chair Stand Test Performance From Baseline to 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 St. George's Respiratory Questionnaire Total Score From Baseline to 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 | 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 |
| 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. |
| Baseline, Week 6, and Week 12 |
| 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. | From the first training session to the end of the 12-week intervention |
| 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. | From the first training session to the end of the 12-week intervention |
| Participant retention rate | 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 |