Interval Training in Adults With Congenital Heart Disease a Randomized Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Umeå University
Sponsor:
Information provided by (Responsible Party):
Bengt Johansson, Umeå University
ClinicalTrials.gov Identifier:
NCT01671566
First received: August 20, 2012
Last updated: May 2, 2013
Last verified: May 2013

August 20, 2012
May 2, 2013
September 2012
December 2013   (final data collection date for primary outcome measure)
  • Peak VO2 (ml/kg/min) [ Time Frame: Before homebased interval exrecise regime and after completion (12 weeks) ] [ Designated as safety issue: No ]
    Comparison within and between groups
  • Endurance time [ Time Frame: Before homebased interval exercise regimen and at completion (12 weeks) ] [ Designated as safety issue: No ]
    at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups.
Same as current
Complete list of historical versions of study NCT01671566 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    (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.
  • Adverse events [ Time Frame: Once a week during homebased exercise regime ] [ Designated as safety issue: Yes ]
    Complications to training
  • Quality of life [ Time Frame: Before homebased interval exercise regime and at completion (12 weeks) ] [ Designated as safety issue: No ]
    The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison between and within groups.
  • Physical activity level [ Time Frame: Before homebased interval exercise regime and after completion (12 weeks) ] [ Designated as safety issue: No ]
    The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
  • Exercise self-efficacy [ Time Frame: Before homebased interval exercise regime and after completion ] [ Designated as safety issue: No ]
    The Exercise Self-Efficacy Scale will be used. Comparison within and between groups
  • Anxiety and depression [ Time Frame: Before homebased interval exercise regime and after completion (12 weeks) ] [ Designated as safety issue: No ]
    The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison between and within groups.
  • Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt). [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    ( 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.
  • Peak VO2( ml/kg/min) [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    Comparison within and between groups
  • Endurance time [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    at CPET incremental and constant work rate at 75% of peak work rate (Watt)
  • Quality of life [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison within and between groups.
  • Physical Activity level [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
  • Anxiety and depression [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison within and between groups.
  • Response during CPET incremental and constant work rate test at 80% of peak VO2 [ Time Frame: Before homebased interval exercise regime and at completion (12 weeks) ] [ Designated as safety issue: No ]
    (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.
  • Adverse events [ Time Frame: Once a week during homebased exercise regime ] [ Designated as safety issue: Yes ]
    Complications to training
  • Quality of life [ Time Frame: Before homebased interval exercise regime and at completion (12 weeks) ] [ Designated as safety issue: No ]
    The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison between and within groups.
  • Physical activity level [ Time Frame: Before homebased interval exercise regime and after completion (12 weeks) ] [ Designated as safety issue: No ]
    The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
  • Exercise self-efficacy [ Time Frame: Before homebased interval exercise regime and after completion ] [ Designated as safety issue: No ]
    The Exercise Self-Efficacy Scale will be used. Comparison within and between groups
  • Anxiety and depression [ Time Frame: Before homebased interval exercise regime and after completion (12 weeks) ] [ Designated as safety issue: No ]
    The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidense of anxiety and depression. Comparison between and within groups.
  • Response during CPET incremental and constant work rate test at 80 % of peak VO2 [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    ( Peak VO2 and Iso time(l/min), VCO2, VE/VCO2, VE/VCO-slope, anaerobic threashold, Peak Heart Rate, Heart Rate recovery, Heart rate response, Peak work rate, Oxygen saturation, Blood pressure, symtoms) Comparison within and between groups.
  • Peak VO2( ml/kg/min) [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    Comparison within and between gruops
  • Endurance time [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    at CPET incremental and constant work rate at 80% of peak VO2
  • Quality of life [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison within and between groups.
  • Physical Activity level [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    The long self administered version of International Physical Activity Qustionaire (IPAQ) will be used to assass physical activity level. Comparison within and between groups.
  • Anxiety and depression [ Time Frame: 12 months after completion ] [ Designated as safety issue: No ]
    The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison within and between groups.
Not Provided
Not Provided
 
Interval Training in Adults With Congenital Heart Disease a Randomized Trial
Effect of Home Based Interval Training on Exercise Capacity and Quality of Life in Adults With Congenital Heart Disease - a Randomized Controlled Multicenter 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Congenital Heart Defects
Behavioral: 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.
  • Experimental: Home based interval training
    12 weeks home based interval training
    Intervention: Behavioral: Home based interval training
  • No Intervention: Control group
    No structured exercise training.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bengt Johansson, MD, PhD +46907852782 bengt.johansson@medicim.umu.se
Sweden
 
NCT01671566
GUCHUmU01
No
Bengt Johansson, Umeå University
Umeå University
Not Provided
Principal Investigator: Bengt Johansson, MD, Phd Umea University
Umeå University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP