Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike)

NCT04056416 | Completed DMC

• 1 other identifier: Pro00057730
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Single ventricular (SV) heart was a uniformly fatal condition before the advances in surgical treatment in 1980. In the present era, 5-year survival rate with SV is 75%, with some centers, including the Stollery Children's Hospital reporting higher survival. Although mortality remains a major concern, the research focus has shifted to management of late complications as well as improving patient physical and mental health related quality of life issues. Children with SV have reduced exercise tolerance and this is progressive through adulthood. Recent advances in remote health assessment and telehealth systems have allowed the development of medically supervised home graduated physical training for adult cardiac patient rehabilitation. To our knowledge, the application of these technologies has not been applied to SV patients. The long term goal is to use this technology to improve patient exercise capacity and to positively influence parental and patient perceptions of the patient's physical ability.

Conditions

Congenital Heart Defect; Hypoplastic Left Heart Syndrome; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Exercise capacity assessed as the change in max VO2 pre- vs. post- completion of the HIIT exercise program. Hypothesis- we will observe an increased in VO2 max of 15%.

  Pre- VO2 max performed 1 week before 24 HIIT exercise sessions and within 1 week after last session

Secondary Outcomes (2)

• Qualitative interviews to determine the perception of exercise in CHD patient

  Pre-interview conducted within 2 weeks of beginning 24 HIIT exercise sessions and post interview conducted within 2 weeks after last session

• Number of participants with exercise program specific adverse events

  Data on acute events are recorded only during the study regiment (24 HIIT sessions); 8 weeks total

Study Arms (1)

HIIT Exercise Program

EXPERIMENTAL

Exercise on a MedBIKE 3 times a week for 8 weeks with pre- and post-CPET testing, questionnaires and qualitative interviews.

Device: MedBIKE

Interventions

MedBIKE DEVICE

A MedBIKE will be installed into a participants home and connected to clinicians via telehealth for monitoring during exercise sessions. Sessions will be based on standardized guidelines for aerobic exercise. Heart rate, ECG, oxygen saturation and rating of perceived exertion will be monitored throughout the session.

HIIT Exercise Program

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• single ventricle patients with Fontan circulation

You may not qualify if:

• Cardiac arrhythmias
• Persistent low resting oxygen saturation of \< 85%
• Severe ventricular dysfunction on most recent clinical echocardiogram
• Patients with reports of chest pain on exertion
• Restricted exercise by cardiologist

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Hypoplastic Left Heart Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Nee Khoo, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: August 14, 2019
• Study Start: March 25, 2019
• Primary Completion: March 19, 2020
• Study Completion: November 9, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

CA (1)