NCT03080662

Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)

Status unknown NA Last updated 15 March 2017

What this trial tests

NA trial testing ORYGEN DUAL Sham Valve in Inspiratory Muscle Training in 20 participants. Status unknown.

Timeline

22 January 2015

Primary endpoint
15 December 2017

15 March 2018

Quick facts

Lead sponsor	Parc de Salut Mar
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	22 January 2015
Primary completion	15 December 2017
Estimated completion	15 March 2018
Sites	1 location across Spain

Drugs / interventions tested

• ORYGEN DUAL Sham Valve
• ORYGEN DUAL Valve

Conditions studied

• Inspiratory Muscle Training — all drugs for Inspiratory Muscle Training →

Sponsor

Parc de Salut Mar — full company profile →

Who can join

Adults 45 to 80, any sex, with Inspiratory Muscle Training. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The impact of the reduction of daily physical activity (DPA) in patients with COPD (chronic obstructive pulmonary disease) is a highly studied area, due to its impact on the quality of life and the clinical evolution of the disease . This fact has multifactorial components: its function is naturally diminished with time, and its effects on the loss of physical condition (decondition). However, dynamic hyperinflation and respiratory muscular dysfunction, especially in patients with more symptomatology, have been identified as those that have the most relevant factors that impact on daily physical activity Due to the detrimental effects of the pulmonary hyperinflation, the diaphragm is flatter and shorter, being in a position of mechanical disadvantage. This contributes to a reduced effort capacity and increase in the dyspnea of patients during daily activities.

Resistance training improves their exercise capacity and reduces dyspnea, however it does not improve inspiratory muscle strength. It is for this reason, that specific training of the inspiratory muscles, offers special interest in patients with decreased inspiratory muscle strength and pulmonary hyperinflation.

Publications & conference data

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

1. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD).
   Burge AT, Cox NS, Abramson MJ, Holland AE. · · 2020 · cited 87× · PMID 32297320 · DOI 10.1002/14651858.cd012626.pub2
2. 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