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Interval Training in Adults With Congenital Heart Disease a Randomized Trial

3. března 2016 aktualizováno: Bengt Johansson, Umeå University

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

26

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Home based interval training
12 weeks home based interval training
Behaviorální: 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.
Žádný zásah: Control group
No structured exercise training.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Peak VO2 (ml/kg/min)
Časové okno: Before homebased interval exrecise regime and after completion (12 weeks)
Comparison within and between groups
Before homebased interval exrecise regime and after completion (12 weeks)
Endurance time
Časové okno: 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.
Before homebased interval exercise regimen and at completion (12 weeks)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
Časové okno: 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.
Before homebased interval exercise regime and at completion (12 weeks)
Adverse events
Časové okno: Once a week during homebased exercise regime
Complications to training
Once a week during homebased exercise regime
Quality of life
Časové okno: 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.
Before homebased interval exercise regime and at completion (12 weeks)
Physical activity level
Časové okno: 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.
Before homebased interval exercise regime and after completion (12 weeks)
Exercise self-efficacy
Časové okno: Before homebased interval exercise regime and after completion
The Exercise Self-Efficacy Scale will be used. Comparison within and between groups
Before homebased interval exercise regime and after completion
Anxiety and depression
Časové okno: 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.
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).
Časové okno: 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.
12 months after completion
Peak VO2( ml/kg/min)
Časové okno: 12 months after completion
Comparison within and between groups
12 months after completion
Endurance time
Časové okno: 12 months after completion
at CPET incremental and constant work rate at 75% of peak work rate (Watt)
12 months after completion
Quality of life
Časové okno: 12 months after completion
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
Časové okno: 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 months after completion
Anxiety and depression
Časové okno: 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.
12 months after completion

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Umeå University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Bengt Johansson, MD, Phd, Umeå University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2012

Primární dokončení (Aktuální)

1. března 2016

Dokončení studie (Aktuální)

1. března 2016

Termíny zápisu do studia

První předloženo

20. srpna 2012

První předloženo, které splnilo kritéria kontroly kvality

20. srpna 2012

První zveřejněno (Odhad)

23. srpna 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

4. března 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. března 2016

Naposledy ověřeno

1. března 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GUCHUmU01

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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