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

Not Applicable

Completed

• Conditions: Exercise Therapy
• Interventions: Other: exercise

• Registration Number: NCT02288442
• Lead Sponsor: Universidad Europea de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Study Start: 2015-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise	exercise	exercise intervention during 8 weeks

Primary Outcome Measures

Name	Time	Method
Muscle power (upper and lower-body)	8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain