Effect of Muscle Strengthening Training in Adults with Fontan Circulation Compared to Healthy Controls
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Umeå University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in muscle oxygenation kinetics evaluated with near-infrared spectroscopy (NIRS).
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Adults with Fontan circulation
Individualised muscle strengthening exercise training protocol.
Intervention: Individualised muscle strengthening exercise training protocol. (Other)
Healthy controls
Individualised muscle strengthening exercise training protocol.
Intervention: Individualised muscle strengthening exercise training protocol. (Other)
Outcomes
Primary Outcomes
Change in muscle oxygenation kinetics evaluated with near-infrared spectroscopy (NIRS).
Time Frame: 10 weeks
Muscle oxygenation kinetics will be evaluated with near-infrared spectroscopy (NIRS) (PortaLite mini, Artinis medical system BV, Netherlands). With light in the near infrared spectra it is possible to measure oxygenated and deoxygenated haemoglobin within the muscle. the muscle oxygenation kinetics till be evaluated pre, during and post exercise of muscle endurance in shoulder flexion and heel raise.
Secondary Outcomes
- Change of muscle mass(10 weeks)
- Change of muscular endurance(10 weeks)
- Change of isometric muscle strength(10 weeks)
- Change of aerobic exercise capacity(10 weeks)