Respiratory Muscle TrainingNCT07042269
Exploring the Time Effect of Respiratory Muscle Training on the Pulmonary Function of Elderly People
A study testing Aerobic Exercise and Respiratory Muscle Training in people with Respiratory Muscle Training and Aerobic Exercise, run by Beijing Sport University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscle Training, Aerobic Exercise, Older Adults
- What is being tested?
- Aerobic Exercise and Respiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults aged 60-75 years; Regardless of sex; Individuals classified as either physically inactive or habitual exercisers;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Respiratory Muscle Training Versus Aerobic Exercise on Cardiopulmonary Function in Older Adults: Determination of Temporal Adaptation Thresholds
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.
Read the 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.
- Being tested
- Aerobic Exercise, Respiratory Muscle Training
- Keywords
- Aerobic Exercise, Respiratory Muscle Training, Cardiopulmonary Function, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Performed daily 10,000-step walking (5 days/week)
Respiratory Muscle TrainingBehavioural
Performed 12-week progressive resistance training using the Lung Fitness® breathing trainer (initial/moderate/high resistance levels)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | * Performed daily 10,000-step walking (5 days/week)
* Exercise adherence was assessed using the Exercise Adherence Questionnaire Receives: Behavioral: Aerobic Exercise |
| Respiratory Muscle Training (RMT) Group | Experimental | * 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 Receives: Behavioral: Respiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle function
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%).
Measured: Each subject was tested at five standardized time points (baseline, week 4, week 8, week 12 [post-intervention], and week 16 [post-detraining]).
Secondary outcomes (1)
Pulmonary function
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.
Measured: Each subject was tested at five standardized time points (baseline, week 4, week 8, week 12 [post-intervention], and week 16 [post-detraining]).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jun 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Muscle TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei Xue Li, Doctor, Study chair, Beijing Sports UniversityXu Guo, Master, Principal investigator, Beijing Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042269
- Sponsor's protocol ID
- 2021096H
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33864832
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Respiratory Muscle Training Versus Aerobic Exercise on Cardiopulmonary Function in Older Adults: Determination of Temporal Adaptation Thresholds
- ClinicalTrials.gov ID
- NCT07042269
- Acronym / sponsor ID
- 2021096H
- Keywords
- Aerobic Exercise, Respiratory Muscle Training, Cardiopulmonary Function, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Behavioral: Aerobic Exercise* Performed daily 10,000-step walking (5 days/week) * Exercise adherence was assessed using the Exercise Adherence Questionnaire |
| Respiratory Muscle Training (RMT) Group | Experimental | Behavioral: Respiratory Muscle Training* 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 |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older adults aged 60-75 years; Regardless of sex; Individuals classified as either physically inactive or habitual exercisers;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExercisePerformed daily 10,000-step walking (5 days/week) | Behavioural | Aerobic Exercise Group |
| Respiratory Muscle TrainingPerformed 12-week progressive resistance training using the Lung Fitness® breathing trainer (initial/moderate/high resistance levels) | Behavioural | Respiratory Muscle Training (RMT) Group |
Primary outcome
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%).
1 secondary outcome
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]).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Results publication: PubMed 33864832Rodrigues 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Xue Li, Doctor study chair
Beijing Sports University
Xu Guo, Master principal investigator
Beijing Sports University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Respiratory Muscle Training in people with Respiratory Muscle Training and Aerobic Exercise, run by Beijing Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07042269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.