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

NCT ID: NCT02288442

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Exercise Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

Group Type NO_INTERVENTION

No interventions assigned to this group

exercise

exercise intervention during 8 weeks

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

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

Interventions

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exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Lucia

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital 12 de Octubre

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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UEMadrid

Identifier Type: -

Identifier Source: org_study_id

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