Respiration Disorders
Conditions
Keywords
Pulmonary Function Impairment, Elastic-Band Resistance Training, Older Adults, Pulmonary Function, Breathing Training, Exercise Intervention, Respiratory Health
Brief summary
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
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.
Interventions
BEHAVIORALElastic-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.
BEHAVIORALElastic-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.
Sponsors
Beijing Sport University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FEV1 Z-Score From Baseline to Week 12 | 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. |
| Change in FVC Z-Score From Baseline to Week 12 | 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. |
| Change in FEV1/FVC Z-Score From Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dominant-Side Quadriceps Strength From Baseline to Week 12 | 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. |
| Change in Forced Vital Capacity From Baseline to Week 12 | 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. |
| Change in Forced Expiratory Volume in 1 Second From Baseline to Week 12 | 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. |
| Change in FEV1/FVC Ratio From Baseline to Week 12 | 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. |
| Change in Non-Dominant-Side Quadriceps Strength From Baseline to Week 12 | 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. |
| Change in Dominant-Side Triceps Surae Strength From Baseline to Week 12 | 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. |
| Change in Non-Dominant-Side Triceps Surae Strength From Baseline to Week 12 | 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. |
| Change in Timed Up and Go Test Performance From Baseline to Week 12 | 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. |
| Change in 2-Minute Step Test Performance From Baseline to Week 12 | 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. |
| Change in 4-Meter Gait Speed From Baseline to 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. | Baseline, Week 6, and Week 12 |
| Change in 30-Second Chair Stand Test Performance From Baseline to Week 12 | 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. |
| Change in St. George's Respiratory Questionnaire Total Score From Baseline to Week 12 | 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. |
| Change in Pittsburgh Sleep Quality Index Total Score From Baseline to Week 12 | 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. |
Countries
China
Contacts
CONTACTChuyuan Qiao, Master
Outcome results
None listed