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CompletedNCT02288442WHOLEi+12Updated Jul 19, 2016

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

An interventional study of exercise in Exercise Therapy, sponsored by Universidad Europea de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-19.

Sponsored by Universidad Europea de Madrid · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Exercise Therapy
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 40 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Universidad Europea de Madrid is the lead sponsor of 94 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Not meeting the above
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    control
  • Experimental
    exercise

    exercise intervention during 8 weeks

    Other: exercise

Interventions

  • Otherexercise

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

06

What researchers measure

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

    Gas-exchange variables at the anaerobic threshold

    Time frame: 8 weeks

  7. NT-ProBNP

    Time frame: 8 weeks

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

    Time frame: 8 weeks

  9. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Hospital 12 de Octubre
    Madrid, 28041, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02288442
Lead sponsor
Universidad Europea de Madrid
Responsible party
Alejandro Lucia (Prof, Universidad Europea de Madrid) — Principal investigator
First posted
Nov 11, 2014
Start date
Jan 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jul 19, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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