Clinical trial NCT01671566: Interval Training in Adults With Congenital Heart Disease a Randomized Trial
Official title: Effect of Home Based Interval Training on Exercise Capacity and Quality of Life in Adults With Congenital Heart Disease - a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defects
Keywords: Congenital Heart defect
Exercise and Physical fitness
Rehabilitation
Quality of life
Behaviour
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Peak VO2 (ml/kg/min)
timeFrame: Before homebased interval exrecise regime and after completion (12 weeks)
measure: Endurance time
timeFrame: Before homebased interval exercise regimen and at completion (12 weeks)
Secondary outcomes:
measure: Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
timeFrame: Before homebased interval exercise regime and at completion (12 weeks)
measure: Adverse events
timeFrame: Once a week during homebased exercise regime
measure: Quality of life
timeFrame: Before homebased interval exercise regime and at completion (12 weeks)
measure: Physical activity level
timeFrame: Before homebased interval exercise regime and after completion (12 weeks)
measure: Exercise self-efficacy
timeFrame: Before homebased interval exercise regime and after completion
measure: Anxiety and depression
timeFrame: Before homebased interval exercise regime and after completion (12 weeks)
measure: Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt).
timeFrame: 12 months after completion
measure: Peak VO2( ml/kg/min)
timeFrame: 12 months after completion
measure: Endurance time
timeFrame: 12 months after completion
measure: Quality of life
timeFrame: 12 months after completion
measure: Physical Activity level
timeFrame: 12 months after completion
measure: Anxiety and depression
timeFrame: 12 months after completion
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University hospital
city: Umeå
country: Sweden
facility: University Hospital
Study officials:
affiliation: Umea University
name: Bengt Johansson, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: