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Effect of Muscle Strengthening Training in Adults with Fontan Circulation

NCT ID: NCT05454254

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-11-30

Brief Summary

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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

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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

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Congenital Heart Disease Univentricular Heart

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adults with Fontan circulation

Individualised muscle strengthening exercise training protocol.

Group Type ACTIVE_COMPARATOR

Individualised muscle strengthening exercise training protocol.

Intervention Type OTHER

Based on the results of muscle function tests at baseline an individualised exercise protocol will be designed.

Healthy controls

Individualised muscle strengthening exercise training protocol.

Group Type ACTIVE_COMPARATOR

Individualised muscle strengthening exercise training protocol.

Intervention Type OTHER

Based on the results of muscle function tests at baseline an individualised exercise protocol will be designed.

Interventions

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Individualised muscle strengthening exercise training protocol.

Based on the results of muscle function tests at baseline an individualised exercise protocol will be designed.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Umeå University Hospital

Umeå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Muscle training Fontan

Identifier Type: -

Identifier Source: org_study_id