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

NCT ID: NCT03080662

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-22
• Study Completion Date: 2018-03-15

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.

Conditions

Inspiratory Muscle Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sham valve (Placebo)

Sham Inspiratory valve (without resistance)

Group Type: SHAM_COMPARATOR

ORYGEN DUAL Sham Valve

Intervention Type: DEVICE

Training of the inspiratory muscles during 5 weeks

Intervention

Inspiratory valve with increase resistance

Group Type: EXPERIMENTAL

ORYGEN DUAL Valve

Intervention Type: DEVICE

Training of the inspiratory muscles during 5 weeks

Interventions

ORYGEN DUAL Sham Valve

Training of the inspiratory muscles during 5 weeks

Intervention Type: DEVICE

ORYGEN DUAL Valve

Training of the inspiratory muscles during 5 weeks

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Diego Agustín Rodríguez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Del Mar

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Diego Agustin Rodriguez, PhD

Role: CONTACT

DARodriguez@parcdesalutmar.cat

0034932483548

Facility Contacts

Diego Agustin Rodriguez, PhD

Role: primary

DARodriguez@parcdesalutmar.cat

0034932483548

Other Identifiers

INAF

Identifier Type: -

Identifier Source: org_study_id