Back to resultsWhole Muscle Exercise Training (WHOLEi+12) in Pulmonary Hypertension (WHOLEi+12)
Primary Purpose
Exercise Therapy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosed pulmonary hypertension, class II-III NYHA, no syncope in the last 3 months (stable clinical condition) or chronic thromboembolic pulmonary hypertension
Exclusion Criteria:
- Not meeting the above
Sites / Locations
- Hospital 12 de Octubre
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
exercise
Arm Description
exercise intervention during 8 weeks
Outcomes
Primary Outcome Measures
Muscle power (upper and lower-body)
Secondary Outcome Measures
6 minute walk distance test
maximal inspiratory pressure (PImax)
Short Form 36-Item Health Survey questionnaire version 2 (SF-36)
Physical activity levels objectively determined with accelerometry
Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT)
Other CEPT variables
Gas-exchange variables at the anaerobic threshold
NT-ProBNP
Performance in the 5-repetition sit-stand-test (5SST)
Safety assessment
Evaluation of adverse episodes, ie. syncopal/pre-syncopal episodes, severe dyspnea, arrhythmias, asthma, signs of poor peripheral perfusion or central nervous symptoms (ataxia, tremors). These episodes were be reported directly by the study researchers (in the exercise group) and by a telephone interview every 2 weeks in all participants.
Full Information
NCT ID
NCT02288442
First Posted
November 5, 2014
Last Updated
July 18, 2016
Sponsor
Universidad Europea de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02288442
Brief Title
Whole Muscle Exercise Training (WHOLEi+12) in Pulmonary Hypertension
Acronym
WHOLEi+12
Official Title
Exercise Training (WHOLEi+12) in Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this RCT is to study the effects of whole muscle training (inspiratory muscle training + aerobic training + muscle resistance training) on muscle power, VO2peak and gas-exchange variables obtained during cardiopulmonary exercise testing, QoL, functional capacity (eg, 6-min walking distance), and maximal inspiratory pressure in patients with pulmonary artery hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Title
exercise
Arm Type
Experimental
Arm Description
exercise intervention during 8 weeks
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Exercise training for 8 weeks (aerobic exercise, resistance training and inspiratory muscle training thrice a week)
Primary Outcome Measure Information:
Title
Muscle power (upper and lower-body)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
6 minute walk distance test
Time Frame
8 weeks
Title
maximal inspiratory pressure (PImax)
Time Frame
8 weeks
Title
Short Form 36-Item Health Survey questionnaire version 2 (SF-36)
Time Frame
8 weeks
Title
Physical activity levels objectively determined with accelerometry
Time Frame
8 weeks
Title
Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT)
Time Frame
8 weeks
Title
Other CEPT variables
Description
Gas-exchange variables at the anaerobic threshold
Time Frame
8 weeks
Title
NT-ProBNP
Time Frame
8 weeks
Title
Performance in the 5-repetition sit-stand-test (5SST)
Time Frame
8 weeks
Title
Safety assessment
Description
Evaluation of adverse episodes, ie. syncopal/pre-syncopal episodes, severe dyspnea, arrhythmias, asthma, signs of poor peripheral perfusion or central nervous symptoms (ataxia, tremors). These episodes were be reported directly by the study researchers (in the exercise group) and by a telephone interview every 2 weeks in all participants.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed pulmonary hypertension, class II-III NYHA, no syncope in the last 3 months (stable clinical condition) or chronic thromboembolic pulmonary hypertension
Exclusion Criteria:
Not meeting the above
Facility Information:
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
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Whole Muscle Exercise Training (WHOLEi+12) in Pulmonary Hypertension
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