NCT07612072

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jun 2026Sep 2026

First Submitted

Initial submission to the registry

May 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2026

Last Updated

July 2, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 21, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

Pulmonary Function ImpairmentElastic-Band Resistance TrainingOlder AdultsPulmonary FunctionBreathing TrainingExercise InterventionRespiratory Health

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (13)

  • Change in Dominant-Side Quadriceps Strength From Baseline to Week 12

    Baseline, Week 6, and Week 12

  • 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 Non-Dominant-Side Quadriceps Strength From Baseline to Week 12

    Baseline, Week 6, and Week 12

  • +8 more secondary outcomes

Other Outcomes (5)

  • Change in Dominant-Side Handgrip Strength From Baseline to Week 12

    Baseline, Week 6, and Week 12

  • Change in Non-Dominant-Side Handgrip Strength From Baseline to Week 12

    Baseline, Week 6, and Week 12

  • Intervention adherence

    From the first training session to the end of the 12-week intervention

  • +2 more other outcomes

Study Arms (3)

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.

Behavioral: Elastic-Band Resistance Training Plus Breathing TrainingBehavioral: Elastic-Band Resistance Training

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.

Behavioral: Elastic-Band Resistance Training

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.

Interventions

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.

Elastic-Band Resistance Training Plus Breathing 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.

Elastic-Band Resistance TrainingElastic-Band Resistance Training Plus Breathing Training

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Chuyuan Qiao, Master

CONTACT

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
Model Details: 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.
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

July 2, 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.

Locations