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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
  Purpose

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.


Condition Intervention
Congenital Heart Defects
Behavioral: Home based interval training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 66
Study Start Date: September 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home based interval training
12 weeks home based interval training
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.
No Intervention: Control group
No structured exercise training.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671566

Contacts
Contact: Bengt Johansson, MD, PhD +46907852782 bengt.johansson@medicim.umu.se

Locations
Sweden
Sahlgrenska University hospital Recruiting
Gothenburg, Sweden, SE- 413 45
Contact: Mikael Dellborg, MD, PhD         
University Hospital Recruiting
Umeå, Sweden, 90185
Contact: Bengt Johansson, MD    +46907852782    bengt.johansson@medicin.umu.se   
Contact: Camilla Sandberg, Doctoral student    +46907858441    camilla.sandberg@medicin.umu.se   
Principal Investigator: Bengt Johansson, MD, PhD         
Sub-Investigator: Camilla Sandberg Sandberg, Doctoral student         
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Bengt Johansson, MD, Phd Umea University
  More Information

No publications provided

Responsible Party: Bengt Johansson, MD,PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01671566     History of Changes
Other Study ID Numbers: GUCHUmU01
Study First Received: August 20, 2012
Last Updated: May 2, 2013
Health Authority: Sweden: Institutional Review Board

Keywords provided by Umeå University:
Congenital Heart defect
Exercise and Physical fitness
Rehabilitation
Quality of life
Behaviour

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 24, 2014