Congenital Heart DiseaseNCT05454254
Effect of Muscle Strengthening Training in Adults with Fontan Circulation
A study testing Individualised muscle strengthening exercise training protocol. in people with Congenital Heart Disease and Univentricular Heart, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Univentricular Heart
- What is being tested?
- Individualised muscle strengthening exercise training protocol.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age minimum 18 years
- Patients: Congenital heart disease (Fontan circulation, univentricle heart)
- Controls: no known congenital heart disease.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Muscle Strengthening Training in Adults with Fontan Circulation Compared to Healthy Controls
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.
Read the 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.
- Conditions
- Congenital Heart Disease, Univentricular Heart
- Being tested
- Individualised muscle strengthening exercise training protocol.
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised muscle strengthening exercise training protocol.Other
Based on the results of muscle function tests at baseline an individualised exercise protocol will be designed.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Fontan circulation | Active comparator | Individualised muscle strengthening exercise training protocol. Receives: Other: Individualised muscle strengthening exercise training protocol. |
| Healthy controls | Active comparator | Individualised muscle strengthening exercise training protocol. Receives: Other: Individualised muscle strengthening exercise training protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (4)
Change of isometric muscle strength
Isometric muscle strength in elbow flexion and knee extension will be assessed with a load cell amplifier (VZ101BH 500kg, Anyload Weigh \& Measure Inc.,NJ, US). Maximal muscle contraction will be performed during five seconds. The test is repeated three times with a one-minute rest in between. Isometric grip strength will be assessed with a handheld dynamometer (JAMAR, Lafayette, IN, USA). The handle is pressed during three seconds and the test is repeated three times, with a one-minute rest in between. The tests are performed at baseline and at follow up after 10 weeks muscle training exercise protocol.
Measured: 10 weeks
Change of muscular endurance
Muscle endurance in shoulder flexion will be assessed with a dumbbell (women 2 kg, men 3 kg) and performed in pace with a metronome, 20 contractions per minute (40 beats per minute). Muscle endurance in the calf muscles will be assessed with heel raise with 10 degrees dorsal flexion in the ankle. The test is performed in pace with a metronome with 30 contractions per minute (60 beats per minute). To evaluate muscle endurance in elbow flexion and knee extension, the test person lifts a weight representing 80% of repetition maximum measured at isometric strength. During all tests, the test person performs as many contractions as possible.
Measured: 10 weeks
Change of muscle mass
Evaluation of muscle mass and muscle density is performed with peripheral quantitative computed tomography (PQCT) which analyse cross section of under arms and lower legs with a low radiation dose (0.01 mSV).
Measured: 10 weeks
Change of aerobic exercise capacity
Cardiopulmonary exercise tests (CPET) are performed according to standardised protocols with incremental increase of workload. During CPET oxygen and carbon dioxide is measured continuously in the inhaled and exhaled air. Peak watt and peak oxygen uptake capacity (peak VO2) is noted. CPET is used to evaluate the effect of muscle strengthening exercise on the aerobic capacity.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start15 Aug 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454254
- Sponsor's protocol ID
- Muscle training Fontan
- Status last verified
- May 2023
- First submitted
- 7 Jul 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wikner A, Bergman F, Rinnstrom D, Johansson K, Ljungberg J, Johansson B, Sandberg C. Effects of strength training on isometric muscle strength and muscle cross-sectional area in adults with a Fontan circulation: a pilot study. Int J Cardiol Congenit Heart Dis. 2026 Sep 27;26:100716. doi: 10.1016/j.ijcchd.2026.100716. eCollection 2026 Dec.
PubMed 42960030Wikner 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.
PubMed 41424146
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Strengthening Training in Adults with Fontan Circulation Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT05454254
- Acronym / sponsor ID
- Muscle training Fontan
- Conditions
- Congenital Heart Disease, Univentricular Heart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with Fontan circulation | Active comparator | Other: Individualised muscle strengthening exercise training protocol.Individualised muscle strengthening exercise training protocol. |
| Healthy controls | Active comparator | Other: Individualised muscle strengthening exercise training protocol.Individualised muscle strengthening exercise training protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age minimum 18 years
- Patients: Congenital heart disease (Fontan circulation, univentricle heart)
- Controls: no known congenital heart disease.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualised muscle strengthening exercise training protocol.Based on the results of muscle function tests at baseline an individualised exercise protocol will be designed. | Other | Adults with Fontan circulation, Healthy controls |
Primary outcome
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.
4 secondary outcomes
Change of isometric muscle strength
Time frame: 10 weeks
Change of muscular endurance
Time frame: 10 weeks
Change of muscle mass
Time frame: 10 weeks
Change of aerobic exercise capacity
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 42960030Wikner A, Bergman F, Rinnstrom D, Johansson K, Ljungberg J, Johansson B, Sandberg C. Effects of strength training on isometric muscle strength and muscle cross-sectional area in adults with a Fontan circulation: a pilot study. Int J Cardiol Congenit Heart Dis. 2026 Sep 27;26:100716. doi: 10.1016/j.ijcchd.2026.100716. eCollection 2026 Dec.
- Derived from this study: PubMed 41424146Wikner 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.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised muscle strengthening exercise training protocol. in people with Congenital Heart Disease and Univentricular Heart, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle oxygenation kinetics evaluated with near-infrared spectroscopy (NIRS). (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.