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

Inspiratory Muscle Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03080662
• Other study ID #: INAF
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2017
• Last updated: March 14, 2017
• Start date: January 22, 2015
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2017
• Source: Parc de Salut Mar
• Contact: Diego Agustin Rodriguez, PhD
• Phone: 0034932483548
• Email: DARodriguez[@]parcdesalutmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 15, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inspiratory Muscle Training
• Respiratory Aspiration

Intervention

Device:
• ORYGEN DUAL Sham Valve
Training of the inspiratory muscles during 5 weeks
• ORYGEN DUAL Valve
Training of the inspiratory muscles during 5 weeks

Locations

Country	Name	City	State
Spain	Hospital Del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of daily physical activity	Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer	Baseline and 5 weeks