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
1 other identifier
interventional
75
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2026
CompletedFirst Posted
Study publicly available on registry
May 28, 2026
CompletedStudy Start
First participant enrolled
June 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 16, 2026
June 1, 2026
May 1, 2026
3 months
May 21, 2026
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 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 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 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
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 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 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
Secondary Outcomes (9)
Change in Dominant-Side Quadriceps Strength From Baseline to Week 12
Baseline, Week 6, and Week 12
Change in Non-Dominant-Side Quadriceps Strength From Baseline to Week 12
Baseline, Week 6, and Week 12
Change in Dominant-Side Triceps Surae Strength From Baseline to Week 12
Baseline, Week 6, and Week 12
Change in Non-Dominant-Side Triceps Surae Strength From Baseline to Week 12
Baseline, Week 6, and Week 12
Change in Timed Up and Go Test Performance From Baseline to Week 12
Baseline, Week 6, and Week 12
- +4 more secondary outcomes
Study Arms (3)
Elastic-Band Resistance Training Plus Breathing Training
EXPERIMENTALParticipants 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.
Elastic-Band Resistance Training
ACTIVE COMPARATORParticipants 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.
Usual Health Education
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huayuan Road Community Health Service Center, Haidian District, Beijing
Beijing, Beijing Municipality, 100084, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2026
First Posted
May 28, 2026
Study Start
June 10, 2026
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
September 16, 2026
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.