Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function

NCT02004756 | Terminated Phase 1

• 1 other identifier: 1000016650
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children. Secondary Objectives:

1. 1.To determine if impairments do exist, are they related to exercise capacity.
2. 2.To determine if a 12-week exercise training intervention improves cardiac and/or musculoskeletal metabolism.

Conditions

Congenital Heart Disease

Keywords

pediatric; fontan; congenital heart disease; cardiac and musculoskeletal funion; cardiac and/or musculoskeletal metabolism; exercise training intervention

Outcome Measures

Primary Outcomes (1)

• Cardiac and skeletal function and metabolism

  Blood oxygen level dependent functional magnetic resonance imaging (BOLD fMRI), and 31P-MRS will allow for the precise measurement of cardiac and musculoskeletal function, circulatory perfusion and vascular reactivity, and aerobic and anaerobic metabolism, respectively. Cardiac function will be examined via MRI and exercise echocardiography.

  1 day

Study Arms (2)

Fontan Patients

EXPERIMENTAL

Fontan patients who are monitored at the Hospital for Sick Children (SickKids) will undergo an exercise program

Other: Exercise Program

Healthy Controls

NO INTERVENTION

Healthy age-matched adolescents

Interventions

Exercise Program OTHER

The Fontan cohort will subsequently complete a 12-week moderate intensity exercise intervention whereby individualized activity-based home interventions will be prescribed (i.e., sample activities: walking, jogging, swimming, cycling, soccer). More specifically, individualized weekly exercise programs for participants will be provided incorporating two specific exercise components.

Fontan Patients

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Fontan Patients:
• Patients who have had the Fontan cardiac procedure
• years of age
• Written Informed Consent
• Healthy Controls:
• years of age
• Written Informed Consent

You may not qualify if:

• Fontan Patients:
• Contraindication to exercise
• Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
• Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
• Patients with a known allergy to gadolinium.
• Patients with a history of allergic disposition or have anaphylactic reactions
• Moderate-to-severe renal impairment (defined as having a GFR/ eGFR \< 60 mL/min)
• Have Sickle Cell anemia
• Known pregnancy, or breast feeding
• Patient is uncooperative during a MRI without sedation or anesthesia
• Healthy Controls:
• Contraindication to exercise
• Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
• Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy)
• Patient is uncooperative during a MRI without sedation or anesthesia

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brian McCrindle, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

CA (1)