NCT02288442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

November 5, 2014

Last Update Submit

July 18, 2016

Conditions

Exercise Therapy

Outcome Measures

Primary Outcomes (1)

  • Muscle power (upper and lower-body)

    8 weeks

Secondary Outcomes (9)

  • 6 minute walk distance test

    8 weeks

  • 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 accelerometry

    8 weeks

  • Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT)

    8 weeks

  • +4 more secondary outcomes

Study Arms (2)

control

NO INTERVENTION

exercise

EXPERIMENTAL

exercise intervention during 8 weeks

Other: exercise

Interventions

exerciseOTHER

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

exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed pulmonary hypertension, class II-III NYHA, no syncope in the last 3 months (stable clinical condition) or chronic thromboembolic pulmonary hypertension

You may not qualify if:

  • Not meeting the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 11, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

ES(1)