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

Exercise Therapy Clinical Trial

— WHOLEi+12  

Official title:

Exercise Training (WHOLEi+12) in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288442
• Other study ID #: UEMadrid
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: July 18, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Dirección General de Farmacia y Productos Sanitarios de la Comunidad Autónoma de Madrid, Spain:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise Therapy
• Hypertension
• Hypertension, Pulmonary

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital 12 de Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle power (upper and lower-body)		8 weeks	No
Secondary	6 minute walk distance test		8 weeks	No
Secondary	maximal inspiratory pressure (PImax)		8 weeks	No
Secondary	Short Form 36-Item Health Survey questionnaire version 2 (SF-36)		8 weeks	No
Secondary	Physical activity levels objectively determined with accelerometry		8 weeks	No
Secondary	Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT)		8 weeks	No
Secondary	Other CEPT variables	Gas-exchange variables at the anaerobic threshold	8 weeks	No
Secondary	NT-ProBNP		8 weeks	No
Secondary	Performance in the 5-repetition sit-stand-test (5SST)		8 weeks	No
Secondary	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.	8 weeks	Yes