Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Heart Defects, Congenital; Congenital Heart Disease
• Intervention / Treatment: Other: Cardiopulmonary rehabilitation; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiopulmonary rehabilitation; The subjects will attend 2 sessions each week for 12 weeks. Each session will be approximately 2 hours in duration, consisting of both exercise (aerobic and strength,~60 minutes) and education. In addition, subjects will be directed to participate in 3 weekly ~40 minute home exercise training sessions, personalized to their level of aerobic conditioning.	Other: Cardiopulmonary rehabilitation; See Arm Description
Other: Standard of care; Subjects randomized to standard of care will not be enrolled in a rehabilitation program, but may receive any other clinically indicated exercise training or other intervention (e.g., an exercise prescription).	Other: Standard of care; See Arm Description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in aerobic exercise capacity (peak VO2)	Baseline to 3 months (primary)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in quality of life measurement	Baseline to 3 months (primary)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak cardiac output and its components (SV/HR)		Baseline to 3 months (primary)
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)
Change in ventilatory efficiency		Baseline to 3 months (primary)
Change in strength (dynamometry)		Baseline to 3 months (primary)
Change in pulse wave velocity		Baseline to 3 months
Change in circulating biomarkers		Baseline to 3 months (primary)
Change in markers of pulse reflection		Baseline to 3 months
Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation		Baseline to 3 months
Change in physical activity	Survey and accelerometry	Baseline to 3 months
Change in markers of ventricular function		Baseline to 3 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Alexander Opotowsky, Boston Children's Hospital, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: March 28, 2013
• First Posted (Estimate): April 2, 2013

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: exercise; quality of life; congenital heart disease; cardiac rehabilitation; cardiopulmonary exercise testing; adult congenital heart disease; cardiopulmonary rehabilitation; peak vO2
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: P00005391