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

Not Applicable

• Conditions: Inspiratory Muscle Training
• Interventions: Device: ORYGEN DUAL Sham Valve; Device: ORYGEN DUAL Valve

• Registration Number: NCT03080662
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-22
• Status Verified: 2017-03
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-15
• Last Update Posted: 2017-03-15
• Primary Completion: 2017-12-15
• Study Completion: 2018-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• To be eligible for the respiratory rehabilitation programme participants must have stable COPD (at least 4 weeks), inspiratory muscle weakness (PImax <70%) and pulmonary hyperinflation (TLC > 120%). Patient that have signed inform consent.

Exclusion Criteria

• Hospitalization within the previous 14 days
• Current participation in rehabilitation program,
• Locomotor or neurological condition or disability limiting the ability to perform exercise,
• Lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham valve (Placebo)	ORYGEN DUAL Sham Valve	Sham Inspiratory valve (without resistance)
Intervention	ORYGEN DUAL Valve	Inspiratory valve with increase resistance

Primary Outcome Measures

Name	Time	Method
improvement of daily physical activity	Baseline and 5 weeks	Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer

Trial Locations

Locations (1)

Hospital Del Mar; 🇪🇸 Barcelona, Spain