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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Chuyuan Qiao, Master
- 电话号码：+86-13801107617
- 邮箱：xiaosadashuai@163.com
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100084
- Huayuan Road Community Health Service Center, Haidian District, Beijing
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接触：
- Yan Wang, Doctor
- 电话号码：+86-15201061266
- 邮箱：wyweiwei@126.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：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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实验性的：Elastic-Band Resistance Training Plus Breathing Training
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.
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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.
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.
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有源比较器：Elastic-Band Resistance Training
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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in FEV1 Z-Score From Baseline to Week 12
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in FEV1/FVC Ratio From Baseline to Week 12
大体时间：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
大体时间：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
大体时间：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 30-Second Chair Stand Test Performance From Baseline to Week 12
大体时间：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
大体时间：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
大体时间：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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Change in Dominant-Side Quadriceps Strength From Baseline to Week 12
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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 St. George's Respiratory Questionnaire Total Score From Baseline to Week 12
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Dominant-Side Handgrip Strength From Baseline to Week 12
大体时间：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
大体时间：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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Intervention adherence
大体时间：From the first training session to the end of the 12-week intervention
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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.
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From the first training session to the end of the 12-week intervention
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Total training time
大体时间：From the first training session to the end of the 12-week intervention
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Cumulative duration of completed supervised and home-based training sessions during the 12-week intervention, calculated from attendance records and training logs.
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From the first training session to the end of the 12-week intervention
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Participant retention rate
大体时间：From randomization to the Week 12 follow-up assessment
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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.
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From randomization to the Week 12 follow-up assessment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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其他研究编号
- BeijingSU
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