Effect of Muscle Strengthening Training in Adults with Fontan Circulation

Umeå University

Status: Completed

Conditions: Univentricular Heart; Congenital Heart Disease

Treatments: Other: Individualised muscle strengthening exercise training protocol.

Study type: Interventional

Funder types: Other

Identifiers

NCT05454254

Muscle training Fontan

Details and patient eligibility

About

Aim: to evaluate the effect of muscle strengthening exercise training in adults with Fontan circulation compared to healthy controls.

Hypothesis: adults with Fontan circulation have a relatively lower effect of muscle strengthening exercise training compared to healthy controls.

Full description

10 adults with Fontan circulation will be recruited from the clinic specialised in adults with congenital heart disease at Norrlands Universitetssjukhus. In addition, 10 age- and sex matched controls will be recruited. The sample size is estimated according to a previous study with the same primary outcome. We estimate that 7 patients and 7 controls are needed in the study and plan to enrol 10 patients and 10 controls in case of any drop outs.

Muscle tests will be performed at baseline. Based on the results from the muscle tests, an individualised muscle training exercise protocol will be designed and the participants will be working out at a gym during 10 weeks. After 10 weeks the same tests will be performed to evaluate the effect of the muscle training exercise.

In addition to the muscle tests, muscle mass and aerobic exercise capacity will be evaluated with peripheral quantitative computed tomography and cardiopulmonary exercise test respectively. Physical activity will be mapped with a validated questionnaire (IPAQ) and an accelerometer attached to the participants thigh. Any impact on fatigue will be evaluated with a validated questionnaire (MFI-20). All tests and questionnaires will be performed at baseline and at follow-up.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age minimum 18 years
• Patients: Congenital heart disease (Fontan circulation, univentricle heart)
• Controls: no known congenital heart disease.

Exclusion criteria

• Muscle strenghtening exercise training at regular basis (2 times/week or more)
• Active disease or other condition that affect exercise training (e.g. rheumatoid arthritis)
• Cognitive or psychological affection
• Other conditions that affect independent decision-making competence

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Adults with Fontan circulation

Active Comparator group

Description:

Individualised muscle strengthening exercise training protocol.

Treatment:

Other: Individualised muscle strengthening exercise training protocol.

Healthy controls

Active Comparator group

Description:

Individualised muscle strengthening exercise training protocol.

Treatment:

Other: Individualised muscle strengthening exercise training protocol.