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

NCT04056416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-11-30

No results posted yet for this study

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

Interventions

DEVICE

MedBIKE

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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Nee Khoo, MD · University of Alberta

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2020-03-19
Completion
2022-11-09

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056416 on ClinicalTrials.gov