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

NCT03080662 | Unknown

• 1 other identifier: INAF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• improvement of daily physical activity

  Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer

  Baseline and 5 weeks

Study Arms (2)

Sham valve (Placebo)

SHAM COMPARATOR

Sham Inspiratory valve (without resistance)

Device: ORYGEN DUAL Sham Valve

Intervention

EXPERIMENTAL

Inspiratory valve with increase resistance

Device: ORYGEN DUAL Valve

Interventions

ORYGEN DUAL Sham Valve DEVICE

Training of the inspiratory muscles during 5 weeks

Sham valve (Placebo)

ORYGEN DUAL Valve DEVICE

Training of the inspiratory muscles during 5 weeks

Intervention

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital Del Mar

Barcelona, Barcelona, 08003, Spain

RECRUITING

Central Study Contacts

Diego Agustin Rodriguez, PhD

CONTACT

0034932483548; DARodriguez@parcdesalutmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 15, 2017
• Study Start: January 22, 2015
• Primary Completion: December 15, 2017
• Study Completion: March 15, 2018
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)