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

Exercise Training (WHOLEi+12) in Pulmonary Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02288442
Acronym
WHOLEi+12
Enrollment
40
Registered
2014-11-11
Start date
2015-01-31
Completion date
2016-06-30
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Therapy

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.

Interventions

OTHERexercise

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

Sponsors

Universidad Europea de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Muscle power (upper and lower-body)8 weeks

Secondary

MeasureTime frameDescription
maximal inspiratory pressure (PImax)8 weeks
Short Form 36-Item Health Survey questionnaire version 2 (SF-36)8 weeks
Physical activity levels objectively determined with accelerometry8 weeks
Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT)8 weeks
6 minute walk distance test8 weeks
NT-ProBNP8 weeks
Performance in the 5-repetition sit-stand-test (5SST)8 weeks
Safety assessment8 weeksEvaluation 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.
Other CEPT variables8 weeksGas-exchange variables at the anaerobic threshold

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026