Whole Muscle Exercise Training (WHOLEi+12) in Pulmonary Hypertension (WHOLEi+12)

July 18, 2016 updated by: Alejandro Lucia, Universidad Europea de Madrid

Exercise Training (WHOLEi+12) in Pulmonary Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: control
Experimental: exercise
exercise intervention during 8 weeks
Other: exercise
Exercise training for 8 weeks (aerobic exercise, resistance training and inspiratory muscle training thrice a week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle power (upper and lower-body)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk distance test
Time Frame: 8 weeks
8 weeks
maximal inspiratory pressure (PImax)
Time Frame: 8 weeks
8 weeks
Short Form 36-Item Health Survey questionnaire version 2 (SF-36)
Time Frame: 8 weeks
8 weeks
Physical activity levels objectively determined with accelerometry
Time Frame: 8 weeks
8 weeks
Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT)
Time Frame: 8 weeks
8 weeks
Other CEPT variables
Time Frame: 8 weeks
Gas-exchange variables at the anaerobic threshold
8 weeks
NT-ProBNP
Time Frame: 8 weeks
8 weeks
Performance in the 5-repetition sit-stand-test (5SST)
Time Frame: 8 weeks
8 weeks
Safety assessment
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEMadrid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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