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Completed

NCT Number: NCT07042269

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

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Sports University

Beijing, Beijing Municipality, 100084, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Behavioral

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

Respiratory muscle training

Behavioral

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

Primary outcomes

  1. Inspiratory muscle function

    Time frame: Each subject was tested at five standardized time points (baseline, week 4, week 8, week 12 [post-intervention], and week 16 [post-detraining]).

    Inspiratory muscle function was quantified using a calibrated POWERbreathe K5 device (POWERbreathe International, Ltd., Southam, UK). Following standardized procedures [18], MIP and peak inspiratory flow (PIF) were recorded. Three technically acceptable maneuvers were performed at each session, with the highest value retained for analysis (coefficient of variation <10%).

Secondary outcomes

  1. Pulmonary function

    Time frame: Each subject was tested at five standardized time points (baseline, week 4, week 8, week 12 [post-intervention], and week 16 [post-detraining]).

    Pulmonary function was conducted with a CHEST-H101 system (Chest M.I., Inc., Tokyo, Japan) calibrated daily, according to American Thoracic Society/European Respiratory Society (ATS/ERS) technical standards [19]. Parameters included VC, FVC, expiratory volume in one second (FEV1), and maximum expiratory flow rate (PEF). The best of three reproducible trials (within 150 mL or 5% variability) was selected.

Other outcomes

  1. 6MWT

    Time frame: Each subject was tested at five standardized time points (baseline, week 4, week 8, week 12 [post-intervention], and week 16 [post-detraining]).

    The 6MWT was administered on a 30 m indoor walkway with environmental controls (temperature 22 ± 1°C, humidity 50 ± 5%). Participants were instructed to "walk as far as possible" following ATS guidelines [20]. Standardized encouragement ("You're doing well, keep going") was provided during the final minute. The total distance walked was recorded to the nearest 0.5 m using a wheel-mounted measuring device. Immediately post-6MWT, dyspnea and leg fatigue were assessed using the modified Borg CR-10 scale: respiratory perceived exertion (RPE) and peripheral perceived exertion (PPE). Heart rate was continuously monitored via the Suunto Smart Sensor (Suunto Oy, Finland) chest strap, with HRmax defined as the highest 5 s average.

Sponsors and collaborators

Lead sponsor

Beijing Sport University

Other

Registry information

Official study title

Comparative Effects of Respiratory Muscle Training Versus Aerobic Exercise on Cardiopulmonary Function in Older Adults: Determination of Temporal Adaptation Thresholds

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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