Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:

Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822769
• Other study ID #: P00005391
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: January 23, 2018
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. To test this hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic capacity and other physiologic markers improved fitness, as well as assessment of quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Able and willing to participate in a 12-week cardiac rehabilitation program and repeated cardiopulmonary exercise testing

• pVO2=80% predicted (impaired aerobic capacity) on baseline exercise test

• congenital heart disease of at least moderate complexity

Exclusion Criteria:

• Cardiac intervention (cath/surg) within prior 6m

• Planned cardiac intervention (cath/surg) within 12m

• Formal cardiac rehabilitation within 24m

• Current/recent (delivery<90d prior) pregnancy, planned pregnancy within 12m

• Active heart failure, hospitalization or major change in clinical status over prior 30d

• Other recent or planned events expected to have a significant impact on exercise capacity

• Baseline oxygen saturation <92%

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Cardiopulmonary rehabilitation
See Arm Description
• Standard of care
See Arm Description

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in peak cardiac output and its components (SV/HR)		Baseline to 3 months (primary)
Other	Mechanism of change in peak VO2	Cardiac output will be assessed and O2 delivery/extraction will be estimated to define mechanisms of improvement in exercise capacity.	Baseline to 3 months (primary)
Other	Change in ventilatory efficiency		Baseline to 3 months (primary)
Other	Change in strength (dynamometry)		Baseline to 3 months (primary)
Other	Change in pulse wave velocity		Baseline to 3 months
Other	Change in circulating biomarkers		Baseline to 3 months (primary)
Other	Change in markers of pulse reflection		Baseline to 3 months
Other	Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation		Baseline to 3 months
Other	Change in physical activity	Survey and accelerometry	Baseline to 3 months
Other	Change in markers of ventricular function		Baseline to 3 months
Primary	Change in aerobic exercise capacity (peak VO2)		Baseline to 3 months (primary)
Secondary	Change in quality of life measurement		Baseline to 3 months (primary)