Interval Training in Adults With Congenital Heart Disease a Randomized Trial

NCT ID: NCT01671566

Last Updated: 2016-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-03-31

Brief Summary

Adults with congenital heart disease have various degrees of impaired exercise capacity compared to healthy controls. Impaired exercise capacity makes everyday activities more difficult and demanding. There are few studies on effect of exercise training in adults with congenital heart disease. The hypothesis of this study is that structured home based exercise training will improve exercise capacity and health status in the studied population.

Detailed Description

The number adults with congenital heart disease is increasing. Thanks to advances in the medical and surgical fields the number of adults with complex congenital heart disease is now higher than the children with corresponding heart disease. Though the long term prognosis is still unknown and continuously changing as new therapeutic options are introduced.

Persons with congenital heart disease have different degrees of impaired exercise capacity compared to healthy controls. Some studies indicate that this population is not sufficiently active to achieve the recommendations for physical activity in preventing acquired heart disease. Physical inactivity is an important risk factor for developing acquired heart disease and other life style diseases as obesity and diabetes. In a population where one or more previous cardiac surgeries are common, the prevention of life style diseases is especially important. Exercise training in heart failure and coronary artery disease is well studied and there are clinical guidelines. Regarding exercise training in adults with congenital heart disease, however,the information is sparse and further studies are needed.

Based on defined inclusion and exclusion criteria adults with complex congenital heart disease will be recruited in the Northern Health Care Region in Sweden and in Gothenburg. Before and after the twelve week intervention period the investigators will collect information about cardiopulmonary exercise capacity, health related quality of life, exercise self-efficacy, anxiety and depression. The patients will be randomized to twelve weeks of home based interval training or to a control group. The randomization ratio will be 2:1 (intervention:control). The control group will be instructed to continue with their habitual physical activities. The home based interval training program will be individualized based on the results of the exercise tests.

The aim of this study is to examine the effect of home based interval training on maximal and submaximal exercise capacity, quality of life, exercise self-efficacy, anxiety and depression.

Conditions

Congenital Heart Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Home based interval training

12 weeks home based interval training

Group Type: EXPERIMENTAL

Home based interval training

Intervention Type: BEHAVIORAL

The participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity.

Control group

No structured exercise training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home based interval training

The participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Complex congenital heart disease (e.g.; Tetralogy of Fallot, Transpositions of the great arteries, Ebstein, Eisenmenger, Pulmonary atresia or Tricuspid atresia)
• Clinically stable without significant change the last 3 months
• Adult (>18 years)
• Informed consent

Exclusion Criteria

• Signs of arrhythmia on exercise ECG or relevant clinical arrhythmia
• Mental retardation or psychiatric illness affecting the ability of independent decisions
• Other comorbidity affecting physical activity
• Other circumstances making participation unsuitable
• Present strategy of regularly executing physical exercise > 2 times/week in purpose to increase cardiovascular capacity.
• VO2 peak > 30 ml/kg/min
• No access to internet

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Bengt Johansson

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bengt Johansson, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Umea University

Locations

Sahlgrenska University hospital

Gothenburg, Gothenburg, Sweden

University Hospital

Umeå, Umeå, Sweden

Countries

Sweden

Other Identifiers

GUCHUmU01

Identifier Type: -

Identifier Source: org_study_id