Exploring the Time Effect of Respiratory Muscle Training on the Pulmonary Function of Elderly People

NCT ID: NCT07042269

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-07-01

Brief Summary

The goal of this clinical trial is to determine the effects of a 12-week respiratory muscle training (RMT) intervention on cardiopulmonary function and compare its efficacy with aerobic exercise in older adults. The main questions it aims to answer are:

• What are the effects of RMT compared to aerobic exercise on cardiopulmonary function?
• What is the minimal effective duration (temporal threshold) for observable physiological adaptations to RMT?
• To what extent are the training effects retained at 4-weeks post-intervention? Participants were randomly divided into RMT group and aerobic exercise group. The RMT group performed 12 weeks of progressive resistance training (initial, moderate, and high levels) using the Lung Fitness® breathing trainer, consisting of 10 breaths per set, 3 sets per session, twice daily (morning and evening), 5 days per week. The Aerobic Exercise group performed daily 10,000-step walking sessions 5 days per week, with exercise adherence assessed using the Exercise Adherence Questionnaire.

Detailed Description

30 subjects were finally included through the screening criteria. The names of all subjects were entered into Microsoft Excel 2016 and the RAND function was used to generate a random number between 0 and 1 for each subject, each random number being different. Subjects with an odd number of random numbers were assigned to the respiratory muscle training (RMT) group and those with an even number of random numbers were assigned to the aerobic exercise group. The final two intervention groups of 30 participants, were assigned and baseline testing was performed. Testing was repeated at five standardized time points (baseline, week 4, week 8, week 12 [post-intervention], and week 16 [post-detraining]).

The technical route of this study was to collect basic information about the study subjects, including age, height, weight, and to test the inspiratory muscle function, pulmonary function and the 6MWT of the study subjects. The RMT group performed 12 weeks of progressive resistance training (initial, moderate, and high levels) using the Lung Fitness® breathing trainer, consisting of 10 breaths per set, 3 sets per session, twice daily (morning and evening), 5 days per week. The aerobic exercise group performed daily 10,000-step walking sessions 5 days per week, with exercise adherence assessed using the Exercise Adherence Questionnaire.

Basic information and experimental data entry and organization were performed using Microsoft Excel 2016, and the results of all indicators measured before and after the experiment were analyzed and calculated in International Business Machines (IBM) SPSS Statistics 26.0. The data were tested for normality using the Shapiro-Wilk Test (Shapiro-Wilk Test). For the series conforming to the normal distribution, expressed as mean (Mean) and standard deviation (SD). Variables derived from inspiratory muscle function tests, pulmonary function tests, and 6MWT were analyzed for intergroup differences using paired-samples t-tests. Within-group comparisons across different time points in the RMT group were assessed via one-way repeated-measures analysis of variance (ANOVA) with Bonferroni post hoc correction. RPB and RPE were analyzed using nonparametric tests (Wilcoxon signed-rank test). Statistical significance was set at p < .05 (two-tailed). All data were tested for normality using the Shapiro-Wilk test prior to analysis.

Conditions

Respiratory Muscle Training; Aerobic Exercise; Older Adults; Cardiopulmonary Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Aerobic Exercise Group

• Performed daily 10,000-step walking (5 days/week)
• Exercise adherence was assessed using the Exercise Adherence Questionnaire

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

Performed daily 10,000-step walking (5 days/week)

Respiratory Muscle Training (RMT) Group

• Performed 12-week progressive resistance training using the Lung Fitness breathing trainer (initial/moderate/high resistance levels)
• Training protocol: 10 breaths/set, 3 sets/session (morning and evening), 5 days/week
• Technique specification:

1. Diaphragmatic breathing pattern

2. Complete breath cycle = 1 repetition (inhalation ≤3s, exhalation ≤6s)

• Resistance progression:
• Initial level: Expiratory resistance - Level 1; Inspiratory resistance - Level 2
• Moderate level: Expiratory resistance - Level 2; Inspiratory resistance - Level 3
• High level: Expiratory resistance - Level 3; Inspiratory resistance - Level 4

Group Type: EXPERIMENTAL

Respiratory Muscle Training

Intervention Type: BEHAVIORAL

Performed 12-week progressive resistance training using the Lung Fitness® breathing trainer (initial/moderate/high resistance levels)

Interventions

Aerobic Exercise

Performed daily 10,000-step walking (5 days/week)

Intervention Type: BEHAVIORAL

Respiratory Muscle Training

Performed 12-week progressive resistance training using the Lung Fitness® breathing trainer (initial/moderate/high resistance levels)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Older adults aged 60-75 years; Regardless of sex; Individuals classified as either physically inactive or habitual exercisers;

Exclusion Criteria

• Individuals with cardiorespiratory diseases, hypertension, metabolic disorders, or other underlying medical conditions; Persons with impaired mobility, exercise contraindications, or inability to complete the exercise protocol; Inability to independently complete a Six-Minute Walk Test (6MWT) distance.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Sport University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mei Xue Li, Doctor

Role: STUDY_CHAIR

Beijing Sports University

Xu Guo, Master

Role: PRINCIPAL_INVESTIGATOR

Beijing Sports University

Locations

Beijing Sports University

Beijing, Beijing Municipality, China

Countries

China

References

Rodrigues GD, Dal Lago P, da Silva Soares PP. Time-dependent effects of inspiratory muscle training and detraining on cardiac autonomic control in older women. Exp Gerontol. 2021 Jul 15;150:111357. doi: 10.1016/j.exger.2021.111357. Epub 2021 Apr 14.

Reference Type: BACKGROUND

PMID: 33864832 (View on PubMed)

Other Identifiers

2021096H

Identifier Type: -

Identifier Source: org_study_id