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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Defects
• Intervention / Treatment: Behavioral: Home based interval 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, SE- 413 45
    • Sahlgrenska University Hospital
  • Umeå, Sweden, 90185
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak VO2 (ml/kg/min)	Comparison within and between groups	Before homebased interval exrecise regime and after completion (12 weeks)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Adverse events	Complications to training	Once a week during homebased exercise regime
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)
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)
Exercise self-efficacy	The Exercise Self-Efficacy Scale will be used. Comparison within and between groups	Before homebased interval exercise regime and after completion
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)
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
Peak VO2( ml/kg/min)	Comparison within and between groups	12 months after completion
Endurance time	at CPET incremental and constant work rate at 75% of peak work rate (Watt)	12 months after completion
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
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
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

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Bengt Johansson, MD, Phd, Umeå University

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (Estimate): August 23, 2012

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Rehabilitation; Quality of life; Behaviour; Congenital Heart defect; Exercise and Physical fitness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: GUCHUmU01