Digital High-Intensity Respiratory Muscle Training on COPD Patients

Official title

Impact of Digital High-Intensity Respiratory Muscle Training on Ventilatory Function and Functional Capacity in Patients With COPD

Overview

The goal of this Randomize control trail is to determine the effect of Digital High-Intensity Respiratory Muscle Training on ventilatory Function and Functional Capacity in Patients with COPD It will also learn about the safety and tolerability of this digital training program. The main questions it aims to answer are: Does digital high-intensity respiratory muscle training improve inspiratory and expiratory muscle strength (MIP and MEP)? ,Does it improve functional exercise capacity (6-minute walk distance) and lung function (FEV₁, FVC, FEV₁/FVC)?

Detailed description

This single-blinded randomized controlled trial is to determine effect of Digital High-intensity Respiratory Muscle Training delivered through the Sonmol electronic respiratory muscle trainer on ventilatory function and functional capacity in patients with chronic obstructive pulmonary diseases (COPD)

It articulates the clinical rationale by explaining how airflow limitation is caused by COPD and chest hyperinflation, or dysfunction of respiratory muscles, and describes why specific, intense exercise training of muscles of inspiration or expiration may correct or prevent these conditions.

This trial within current evidence supporting respiratory-muscle training and highlights the potential advantages of digital delivery-real-time feedback, adjustable resistance, gamification, and remote monitoring-to boost adherence and training specificity in a rehabilitation context.

The study compares digital high-intensity respiratory muscle training plus conventional pulmonary rehabilitation to conventional pulmonary rehabilitation alone to see if the digital training provides additional benefits.

Interventions

• Device Digital Sonmol Respiratory Muscle Trainer
  The patient will be asked to inhale deeply and forcefully for approximately two to three seconds and have a pause of slightly under a second. Then exhale out of the device and rest for 30 to 60 seconds and will be done for 2 sets of ten breaths, two times per day, for eight weeks The resistance will increase about 10 % to 15 % every week according to patient status in addition to a conventional respiratory rehabilitation program for 25 to 30 Minutes, with a total duration of 50 to 60 minutes for
• Other conventional respiratory rehabilitation
  The patients will receive conventional respiratory Rehabilitation in the form of Diaphragmatic breathing exercise for 5 to 10 minutes and Localized Breathing for lower, middle, and upper segments for 10 to 15 minutes, total session time 25 to 30 minutes for two to four sessions daily for 3 days/ week for 8 weeks

Primary outcome measures

• Ventilatory function measures (FVC, FEV1, and FEV1/FVC) [Time frame: twice, first before beginning treatment from day 1 of treatment second after complete treatment after 2 months ,Assessment will be for 5 minutes for ventilatory function]
• Functional capacity by 6MWT [Time frame: twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 6 minute]

Secondary outcome measures (2)

• Respiratory muscle strength (MIP and MEP). [Time frame: twice, first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 3 minute]
• Patient-reported outcomes by CAT score [Time frame: twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 4 minute]

Eligibility criteria

Inclusion criteria

• Clinical diagnosis of chronic obstructive pulmonary disease (COPD), moderate to severe (GOLD stage II-IV)
• FEV₁ > 80% of predicted.
• Age 50-65 years.
• Able to perform high-intensity respiratory muscle training (MIP and MEP ≥ device threshold).
• Clinically stable with no acute exacerbations.

Exclusion criteria

• Severe comorbidities (e.g., coronary heart disease, arterial aneurysm, severe hepatic or renal dysfunction, uncontrolled hypertension).
• Unstable medical conditions or other respiratory diseases that could cause or contribute to breathlessness (e.g., asthma, pneumonia, bronchiectasis, tuberculosis, interstitial lung disease).
• Mental illness, deafness, limb activity disorder, or any condition causing inability to cooperate with procedures.
• Cognitive impairment or psychiatric illness that affects cooperation.
• Participation in another clinical trial or intervention within the last 3 months.
• Current use of any other respiratory muscle training device or app.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Lin TK, Chen MY, Cheng HH, Chow J, Chen CM, Chou W. Effectiveness of abdominal sandbag training in enhancing diaphragm muscle function and exercise tolerance in patients with chronic respiratory failure. J Formos Med Assoc. 2024 Oct;123(10):1087-1092. doi: 10.1016/j.jfma.2024.01.021. Epub 2024 Feb 1. PMID 38302365
• • World Health Organization. (2024, November 6). Chronic obstructive pulmonary disease (COPD). Retrieved June 22, 2025, from https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)
• Jing Y, Ma Y, Zhang H, Wu Z, Li Y, Li H, Huang M, Lin L, Xu Y. Pulmonary rehabilitation integrated coached exercise training for patients with COPD: a study protocol for a randomized controlled trial. Trials. 2023 Jan 30;24(1):69. doi: 10.1186/s13063-022-07058-2. PMID 36717916
• Han B, Chen Z, Ruan B, Chen Y, Lv Y, Li C, Yu L. Effects of Inspiratory Muscle Training in People with Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Life (Basel). 2024 Nov 12;14(11):1470. doi: 10.3390/life14111470. PMID 39598268
• Furukawa Y, Miyamoto A, Asai K, Tsutsumi M, Hirai K, Ueda T, Toyokura E, Nishimura M, Sato K, Yamada K, Watanabe T, Kawaguchi T. Respiratory Muscle Strength as a Predictor of Exacerbations in Patients With Chronic Obstructive Pulmonary Disease. Respirology. 2025 May;30(5):408-416. doi: 10.1111/resp.70003. Epub 2025 Feb 26. PMID 40009650
• Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Martinez-Arnau FM. Resistance training of peripheral muscles benefits respiratory parameters in older women with sarcopenia: Randomized controlled trial. Arch Gerontol Geriatr. 2023 Jan;104:104799. doi: 10.1016/j.archger.2022.104799. Epub 2022 Aug 29. PMID 36070636
• Chen Q, Wu X, Huang Y, Chen L. Internet of Things-Based Home Respiratory Muscle Training for Patients with Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. Int J Chron Obstruct Pulmon Dis. 2024 May 22;19:1093-1103. doi: 10.2147/COPD.S454804. eCollection 2024. PMID 38800522
• Brito SAF, Scianni AA, Silveira BMF, Oliveira ERM, Mateus ME, Faria CDCM. Effects of high-intensity respiratory muscle training on respiratory muscle strength in individuals with Parkinson's disease: Protocol of a randomized clinical trial. PLoS One. 2023 Sep 8;18(9):e0291051. doi: 10.1371/journal.pone.0291051. eCollection 2023. PMID 37682839

Identifiers

NCT: NCT07346261 · P.T.REC/012/006187

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗