Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)
Primary Purpose
Inspiratory Muscle Training
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ORYGEN DUAL Sham Valve
ORYGEN DUAL Valve
Sponsored by
About this trial
This is an interventional treatment trial for Inspiratory Muscle Training
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.
Sites / Locations
- Hospital Del MarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham valve (Placebo)
Intervention
Arm Description
Sham Inspiratory valve (without resistance)
Inspiratory valve with increase resistance
Outcomes
Primary Outcome Measures
improvement of daily physical activity
Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03080662
Brief Title
Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)
Official Title
Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2015 (Actual)
Primary Completion Date
December 15, 2017 (Anticipated)
Study Completion Date
March 15, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inspiratory Muscle Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham valve (Placebo)
Arm Type
Sham Comparator
Arm Description
Sham Inspiratory valve (without resistance)
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Inspiratory valve with increase resistance
Intervention Type
Device
Intervention Name(s)
ORYGEN DUAL Sham Valve
Intervention Description
Training of the inspiratory muscles during 5 weeks
Intervention Type
Device
Intervention Name(s)
ORYGEN DUAL Valve
Intervention Description
Training of the inspiratory muscles during 5 weeks
Primary Outcome Measure Information:
Title
improvement of daily physical activity
Description
Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer
Time Frame
Baseline and 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Agustin Rodriguez, PhD
Phone
0034932483548
Email
DARodriguez@parcdesalutmar.cat
Facility Information:
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Agustin Rodriguez, PhD
Phone
0034932483548
Email
DARodriguez@parcdesalutmar.cat
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)
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