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Interval Training in Adults With Congenital Heart Disease a Randomized Trial

3. marts 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

26

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Home based interval training
12 weeks home based interval training
Adfærdsmæssigt: 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.
Ingen indgriben: Control group
No structured exercise training.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak VO2 (ml/kg/min)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
Tidsramme: 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
Tidsramme: Once a week during homebased exercise regime
Complications to training
Once a week during homebased exercise regime
Quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 12 months after completion
Comparison within and between groups
12 months after completion
Endurance time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Umeå University

Efterforskere

  • Ledende efterforsker: Bengt Johansson, MD, Phd, Umea University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2012

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. marts 2016

Datoer for studieregistrering

Først indsendt

20. august 2012

Først indsendt, der opfyldte QC-kriterier

20. august 2012

Først opslået (Skøn)

23. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GUCHUmU01

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