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Not yet recruiting NCT07612072

Elastic-Band Resistance and Breathing Training for Older Adults With Pulmonary Function Impairment

No phase Interventional Respiration Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Elastic-Band Resistance Training Plus Breathing Training, Elastic-Band Resistance Training.
Who it may be relevant to
Registry conditions: Respiration Disorders. Basic parameters: 60 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Elastic-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 movemen
  • Behavioral Elastic-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 toleran

Primary outcome measures

  • Change in FEV1 Z-Score From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in FVC Z-Score From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in FEV1/FVC Z-Score From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
Secondary outcome measures (12)
  • Change in Dominant-Side Quadriceps Strength From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in Forced Vital Capacity From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in Forced Expiratory Volume in 1 Second From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in FEV1/FVC Ratio From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in Non-Dominant-Side Quadriceps Strength From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in Dominant-Side Triceps Surae Strength From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in Non-Dominant-Side Triceps Surae Strength From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in Timed Up and Go Test Performance From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in 2-Minute Step Test Performance From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]
  • Change in 4-Meter Gait Speed From Baseline to Week 12 [Time frame: 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 [Time frame: Baseline, Week 6, and Week 12]
  • Change in St. George's Respiratory Questionnaire Total Score From Baseline to Week 12 [Time frame: Baseline, Week 6, and Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Huayuan Road Community Health Service Center, Haidian District, Beijing — Beijing

Identifiers

NCT: NCT07612072 · BeijingSU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗