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Completed

NCT Number: NCT02288442

Whole Muscle 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.

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Key information

Conditions

Exercise Therapy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital 12 de Octubre

Madrid, 28041, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Exercise training for 8 weeks (aerobic exercise, resistance training and inspiratory muscle training thrice a week)

Primary outcomes

  1. Muscle power (upper and lower-body)

    Time frame: 8 weeks

Secondary outcomes

  1. 6 minute walk distance test

    Time frame: 8 weeks

  2. maximal inspiratory pressure (PImax)

    Time frame: 8 weeks

  3. Short Form 36-Item Health Survey questionnaire version 2 (SF-36)

    Time frame: 8 weeks

  4. Physical activity levels objectively determined with accelerometry

    Time frame: 8 weeks

  5. Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT)

    Time frame: 8 weeks

  6. Other CEPT variables

    Time frame: 8 weeks

    Gas-exchange variables at the anaerobic threshold

  7. NT-ProBNP

    Time frame: 8 weeks

  8. Performance in the 5-repetition sit-stand-test (5SST)

    Time frame: 8 weeks

  9. 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.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Exercise Training (WHOLEi+12) in Pulmonary Hypertension

Acronym: WHOLEi+12

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2014
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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