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Clinical Trials/NCT07612072
NCT07612072Not yet recruitingNot Applicable

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

Beijing Sport University1 site in 1 country75 target enrollmentStarted: June 10, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
75
Locations
1

Study Overview

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.

Study Design

Study Type
Interventional
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.

Eligibility Criteria

Ages
60 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: Elastic-Band Resistance Training (Behavioral)

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.

Intervention: Elastic-Band Resistance Training (Behavioral)

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.

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.

Intervention: Elastic-Band Resistance Training Plus Breathing Training (Behavioral)

Outcomes

Primary Outcomes

Not specified

Secondary Outcomes

  • Change in Forced Vital Capacity From Baseline to Week 12(Baseline, Week 6, and Week 12)
  • Change in Forced Expiratory Volume in 1 Second From Baseline to Week 12(Baseline, Week 6, and Week 12)
  • Change in FEV1/FVC Ratio From Baseline to Week 12(Baseline, Week 6, and Week 12)
  • Change in 2-Minute Step Test Performance From Baseline to Week 12(Baseline, Week 6, and Week 12)
  • 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.)
  • Change in 30-Second Chair Stand Test Performance From Baseline to Week 12(Baseline, Week 6, and Week 12)

Investigators

Sponsor
Beijing Sport University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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