Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain, 08003
- Recruiting
- Hospital del Mar
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Contact:
- Diego Agustin Rodriguez, PhD
- Phone Number: 0034932483548
- Email: DARodriguez@parcdesalutmar.cat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham valve (Placebo)
Sham Inspiratory valve (without resistance)
|
Training of the inspiratory muscles during 5 weeks
|
|
Experimental: Intervention
Inspiratory valve with increase resistance
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Training of the inspiratory muscles during 5 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
improvement of daily physical activity
Time Frame: Baseline and 5 weeks
|
Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer
|
Baseline and 5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INAF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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