NCT04387318

Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease

Completed NA Last updated 31 May 2023

What this trial tests

NA trial testing Multimodal training in Chronic Obstructive Pulmonary Disease in 40 participants. Completed in 10 March 2023.

Timeline

1 October 2019

Primary endpoint
10 March 2023

10 March 2023

Quick facts

Lead sponsor	Universidade Federal de Santa Maria
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 October 2019
Primary completion	10 March 2023
Estimated completion	10 March 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Multimodal training
• IMT + Pulmonary Rehabilitation
• NMES + Pulmonary Rehabilitation
• Pulmonary Rehabilitation

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

Universidade Federal de Santa Maria — full company profile →

Who can join

Adults 55 to 80, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic obstructive pulmonary disease (COPD) is a significant current public health problem, characterized by the presence of limited airflow. However, COPD has important manifestations beyond the lungs, the so-called systemic effects. These included dysfunction of peripheral and respiratory muscles. The growing amount of evidence has shown that patients with COPD also present important deficits in postural balance and consequently, increased risk of falling. As an essential part of the management of COPD, pulmonary rehabilitation (PR) alleviates dyspnea and fatigue, improves exercise tolerance and health-related quality of life, and reduces hospital admissions and mortality for COPD patients. Exercise is the key component of PR, which is composed of exercise assessment and training therapy. Currently, two modalities of therapy have been suggested as complementary to pulmonary rehabilitation: inspiratory muscular training (IMT) and neuromuscular electrical stimulation (NMES). Based on the premise that peripheral and respiratory muscle dysfunction can negatively impact postural control of patients with COPD, and given the importance of balance as a modifiable risk factor for falls, it is important to investigate whether the use of these therapeutic modalities (IMT and/or NMES) is capable of improving the short-term effects of pulmonary rehabilitation and also promoting improved balance.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD).
   Ammous O, Feki W, Lotfi T, Khamis AM, et al · · 2023 · cited 72× · PMID 36606682 · DOI 10.1002/14651858.cd013778.pub2
2. Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial.
   Daros Dos Santos T, Pasqualoto AS, Cardoso DM, Da Cruz IBM, et al · · 2023 · cited 2× · PMID 37580800 · DOI 10.1186/s13063-023-07558-9
3. Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial
   de Albuquerque IM, Santos TDd, Pasqualoto AS, Cardoso DM, et al · · 2022 · DOI 10.21203/rs.3.rs-2097470/v1