None listed
Conditions
Brief summary
Congenital heart disease (CHD) is the most common congenital disorder in newborns, with an estimated 2400 Australian babies born with CHD each year. Despite improved survival due to advances in surgical techniques and medical care, premature morbidity and mortality are common. In this multi-centre randomised controlled trial, eligible participants with CHD will be allocated to either a 4-month face-to-face or telehealth moderate-to-vigorous physical activity and exercise training program or a usual care (control) group. Participants allocated in the intervention groups will also engage in an 8-month maintenance phase. Detailed assessment of exercise capacity, body composition, vascular function, physical activity levels, liver stiffness, cardiac function, quality of life, cognitive function, lung function, dietary and nutritional status, peripheral venous pressure, and musculoskeletal fitness will be performed. Testing and assessments will be performed at baseline, 4-months, and 12-months.
Interventions
Eligible participants will be randomised to either a supervised (or partially) physical activity and exercise program of moderate to vigorous intensity, followed by an 8-month maintenance period; or usual care (control) group. Throughout the intervention period, participants in the intervention groups will also receive education to promote a healthy lifestyle. In the intervention groups, a 5-10 minute warm-up and cool down will be performed before and after each session. Adherence will be monitored by recording session attendance. Sessions in the 4-month supervised (or partially supervised) phase will be delivered by exercise professionals (e.g., exercise physiologists, physiotherapists) in small groups. Adolescents and adults with biventricular congenital heart disease will be randomly allocated to a telehealth exercise training group or usual care group; Fontan participants may also be allocated to a traditional exercise training group. Children will be randomly allocated to a physical activity and exercise training group or usual care group. The exercise intervention in the traditional exercise group will involve supervised aerobic (e.g., cycling) and resistance exercise (e.g., leg press, chest press) training 3 times a week for 4 months. Sessions will be ~60-75 minutes and supervised by exercise professionals. Aerobic exercise will commence at 40%-50% of heart rate reserve (HRR) and progress to 70%-80% HRR, as tolerated. The resistance exercise component will involve 3 sets of 8-12 repetitions at 60% of one-repetition maximum (1RM) and progressed to 70% 1RM. The telehealth exercise training group will perform supervised resistance exercise 3 times a week for 4-months on Zoom. Each supervised resistance training session will be ~45-60 minutes in duration. Participants will perform 3 sets of 8-12 repetitions of various exercises using bodyweight or a Gymstick. Resistance exercise intensity and progression will be monitored by rating of perceived exertion on the OMNI scale. Participants in the telehealth exercise training group will also be asked to perform 20 minutes of aerobic exercise training (e.g., walking) independently 3 times a week for 4-months. Aerobic exercise intensity will be monitored by HRR and is consistent with the traditional exercise training group. Children allocated to the intervention group will participate in a 4-month supervised physical activity and exercise training program. Participants will attend a community or fitness facility once a week for ~90 minutes to perform an interval exercise circuit, practice foundational movement skills and engage in physically active games. The average target exercise intensity for the exercise circuit will be 40%-50% HRR initially and will progress to 70%-80% HRR, as tolerated. In addition, children will be provided with tasks to complete at home (e.g., calf raises) that supplements the physical activity program and promotes a healthy lifestyle. During the 8-month maintenance phase, adolescent and adult participants allocated in the exercise intervention groups will be encouraged to continue exercise training independently at least 2 times a week. Children will be encouraged to be physically active and join sports clubs. Follow-up phone calls will be conducted monthly to facilitate ongoing physical activity participation. Participants in the usual care group will continue with routine clinical care and attend testing visits at baseline, 4-months, and 12-months.
Sponsors
Study design
Eligibility
Inclusion criteria
-Aged 10 to 55 years -People with congenital heart disease of moderate or great complexity -At least 6 months post surgical repair -Medically stable and on stable therapy for at least 3 months
Exclusion criteria
-Physiological stage D -Planned intervention within 2 years -Mental or physical disability that prevents participation in exercise training -Current or actively planned pregnancy within one year -Uncontrolled (systemic) hypertension at rest of exercise -Clinically unstable or recent major change in therapy within 3 months -COVID-19 unvaccinated people despite being eligible according to ATAGI -People with unreliable internet connection -People currently participating in more than 30 minutes of sports or exercise training three times a week