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

Parc de Salut Mar

Status: Unknown

Conditions: Inspiratory Muscle Training

Treatments: Device: ORYGEN DUAL Sham Valve; Device: ORYGEN DUAL Valve

Study type: Interventional

Funder types: Other

Identifiers

NCT03080662

INAF

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Sham valve (Placebo)

Sham Comparator group

Description:

Sham Inspiratory valve (without resistance)

Treatment:

Device: ORYGEN DUAL Sham Valve

Intervention

Experimental group

Description:

Inspiratory valve with increase resistance

Treatment:

Device: ORYGEN DUAL Valve