Congenital Heart Defects Clinical 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
Verified date | March 2016 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University hospital | Gothenburg | |
Sweden | University Hospital | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak VO2 (ml/kg/min) | Comparison within and between groups | Before homebased interval exrecise regime and after completion (12 weeks) | No |
Primary | Endurance time | at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups. | Before homebased interval exercise regimen and at completion (12 weeks) | No |
Secondary | Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt). | (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. | Before homebased interval exercise regime and at completion (12 weeks) | No |
Secondary | Adverse events | Complications to training | Once a week during homebased exercise regime | Yes |
Secondary | Quality of life | The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison between and within groups. | Before homebased interval exercise regime and at completion (12 weeks) | No |
Secondary | Physical activity level | The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups. | Before homebased interval exercise regime and after completion (12 weeks) | No |
Secondary | Exercise self-efficacy | The Exercise Self-Efficacy Scale will be used. Comparison within and between groups | Before homebased interval exercise regime and after completion | No |
Secondary | Anxiety and depression | The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison between and within groups. | Before homebased interval exercise regime and after completion (12 weeks) | No |
Secondary | Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt). | ( 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. | 12 months after completion | No |
Secondary | Peak VO2( ml/kg/min) | Comparison within and between groups | 12 months after completion | No |
Secondary | Endurance time | at CPET incremental and constant work rate at 75% of peak work rate (Watt) | 12 months after completion | No |
Secondary | Quality of life | The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison within and between groups. | 12 months after completion | No |
Secondary | Physical Activity level | 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 months after completion | No |
Secondary | Anxiety and depression | The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison within and between groups. | 12 months after completion | No |
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