NCT01463800

Brief Summary

Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing provides a reliable tool both for assessing exercise capacity of CHD patients and for risk stratification and is becoming part of the routine clinical assessment of these patients. Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise training has been widely studied in chronic heart failure, its efficacy in adults with CHD remain unknown. The investigators hypothesize that structured exercise training will improve exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study is to evaluate the impact of structured exercise training on exercise intolerance in patients with complex CHD.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
terminated

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

Study Start

First participant enrolled

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

5 years

First QC Date

October 28, 2011

Last Update Submit

September 28, 2017

Conditions

Heart Defects, Congenital

Keywords

Heart Defects, congenital

Outcome Measures

Primary Outcomes (1)

  • peak VO2

    Comparison between both groups

    12 weeks

Secondary Outcomes (13)

  • 6 minute walk test

    12 weeks

  • VE/VCO2

    12 weeks

  • heart rate response

    12 weeks

  • QoL

    12 weeks

  • BNP

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Structured Exercise training

ACTIVE COMPARATOR

12 weeks ambulatory low level exercise training

Behavioral: Structured exercise training

Control group

NO INTERVENTION

No structured exercise training

Interventions

Structured exercise trainingBEHAVIORAL

12 weeks low level ambulatory structured exercise training

Structured Exercise training

Eligibility Criteria

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

You may qualify if:

  • Patients with complex CHD including cyanotic heart disease, subaortic right ventricle physiology, single ventricle physiology, Ebstein anomaly with ≥ moderate tricuspid regurgitation and patients with Tetralogy of Fallot (including those with pulmonary atresia of Fallot type or double-outlet right ventricle of Fallot type) and either residual free pulmonary regurgitation or left- or right ventricular systolic dysfunction (demonstrated by echocardiography or cardiac MRI).
  • Peak VO2 \< 85% of predicted (standardized for age, gender, weight and height) obtained by cardiopulmonary exercise testing
  • Sedentary lifestyle (\< 30 minutes of regular exercise per week)

You may not qualify if:

  • Patients with dyspnea New York Heart Association (NYHA) class IV.
  • Severe left ventricular outflow tract obstruction.
  • Unstable angina or recent myocardial infarction (\<12 months).
  • Uncontrolled ventricular arrhythmia.
  • Recent intervention (\<12 months)
  • Life expectancy \<12 months
  • No consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Virgen Macarena University Hospital

Seville, Spain

Location

University Hospital Basel

Basel, 4052, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Daniel Tobler, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 2, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2016

Study Completion

January 1, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

CH(3)ES(1)