Whole Muscle Exercise Training (WHOLEi+12) in Pulmonary H... | NCT02288442

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

NCT02288442

Sponsor

Universidad Europea de Madrid

Status

Completed

Last Update Posted

Jul 19, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Exercise Therapy

Interventions

exercise

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Nov 5, 2014

First Submission Date that Met QC Criteria

Nov 6, 2014

First Posted Date

Nov 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2016

Last Update Posted Date

Jul 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	No Intervention
exercise	Experimental	exercise intervention during 8 weeks	Other: exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise	Other	Exercise training for 8 weeks (aerobic exercise, resistance training and inspiratory muscle training thrice a week)	exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle power (upper and lower-body)		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
6 minute walk distance test		8 weeks
maximal inspiratory pressure (PImax)		8 weeks
Short Form 36-Item Health Survey questionnaire version 2 (SF-36)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital 12 de Octubre		Madrid	Madrid	28041	Spain

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided