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NCT Number: NCT01671566

Interval Training in Adults With Congenital Heart Disease a Randomized Trial

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.

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Key information

Conditions

Congenital Heart Defects Behavior Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University hospital, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home based interval training

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.

Primary outcomes

  1. Peak VO2 (ml/kg/min)

    Time frame: Before homebased interval exrecise regime and after completion (12 weeks)

    Comparison within and between groups

  2. Endurance time

    Time frame: Before homebased interval exercise regimen and at completion (12 weeks)

    at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups.

Secondary outcomes

  1. Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).

    Time frame: Before homebased interval exercise regime and at completion (12 weeks)

    (Peak VO2 (l/min) and Iso time, VCO2, VE/VCO2, VE/VCO2-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart Rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.

  2. Adverse events

    Time frame: Once a week during homebased exercise regime

    Complications to training

  3. Quality of life

    Time frame: Before homebased interval exercise regime and at completion (12 weeks)

    The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison between and within groups.

  4. Physical activity level

    Time frame: Before homebased interval exercise regime and after completion (12 weeks)

    The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.

  5. Exercise self-efficacy

    Time frame: Before homebased interval exercise regime and after completion

    The Exercise Self-Efficacy Scale will be used. Comparison within and between groups

  6. Anxiety and depression

    Time frame: Before homebased interval exercise regime and after completion (12 weeks)

    The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison between and within groups.

  7. Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt).

    Time frame: 12 months after completion

    ( Peak VO2 and Iso time(l/min), VCO2, VE/VCO2, VE/VCO-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.

  8. Peak VO2( ml/kg/min)

    Time frame: 12 months after completion

    Comparison within and between groups

  9. Endurance time

    Time frame: 12 months after completion

    at CPET incremental and constant work rate at 75% of peak work rate (Watt)

  10. Quality of life

    Time frame: 12 months after completion

    The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison within and between groups.

  11. Physical Activity level

    Time frame: 12 months after completion

    The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.

  12. Anxiety and depression

    Time frame: 12 months after completion

    The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison within and between groups.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 23, 2012
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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