Effect of Muscle Strengthening Training in Adults with Fontan Circulation
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedDecember 12, 2024
May 1, 2023
1.3 years
July 7, 2022
December 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in muscle oxygenation kinetics evaluated with near-infrared spectroscopy (NIRS).
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.
10 weeks
Secondary Outcomes (4)
Change of isometric muscle strength
10 weeks
Change of muscular endurance
10 weeks
Change of muscle mass
10 weeks
Change of aerobic exercise capacity
10 weeks
Study Arms (2)
Adults with Fontan circulation
ACTIVE COMPARATORIndividualised muscle strengthening exercise training protocol.
Healthy controls
ACTIVE COMPARATORIndividualised muscle strengthening exercise training protocol.
Interventions
Based on the results of muscle function tests at baseline an individualised exercise protocol will be designed.
Eligibility Criteria
You may qualify if:
- Age minimum 18 years
- Patients: Congenital heart disease (Fontan circulation, univentricle heart)
- Controls: no known congenital heart disease.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (1)
Umeå University Hospital
Umeå, Sweden
Related Publications (1)
Wikner A, Rinnstrom D, Johansson K, Bergman F, Ljungberg J, Johansson B, Sandberg C. Positive effects of strength training on dynamic muscle function in adults with Fontan circulation: a pilot study. Cardiol Young. 2025 Dec 22:1-8. doi: 10.1017/S1047951125110457. Online ahead of print.
PMID: 41424146DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 12, 2022
Study Start
August 15, 2022
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
December 12, 2024
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share