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

NCT07042269 | Completed DMC

• 1 other identifier: 2021096H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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%).

  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

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

Other Outcomes (1)

• 6MWT

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

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

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

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

Behavioral: Respiratory Muscle Training

Interventions

Aerobic Exercise BEHAVIORAL

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

Aerobic Exercise Group

Respiratory Muscle Training BEHAVIORAL

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

Respiratory Muscle Training (RMT) Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Sport University: lead

Study Sites (1)

Beijing Sports University

Beijing, Beijing Municipality, 100084, China

Location

Related Publications (1)

• 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.

  PMID: 33864832 BACKGROUND

MeSH Terms

Interventions

Exercise; Breathing Exercises

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Mei Xue Li, Doctor

  Beijing Sports University

  STUDY CHAIR

• Xu Guo, Master

  Beijing Sports University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: June 29, 2025
• Study Start: June 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

CN (1)