- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01671566
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Gothenburg, Zweden, SE- 413 45
- Sahlgrenska University Hospital
-
Umeå, Zweden, 90185
- University Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Home based interval training
12 weeks 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.
|
Geen tussenkomst: Control group
No structured exercise training.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Peak VO2 (ml/kg/min)
Tijdsspanne: 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
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
Tijdsspanne: 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
Tijdsspanne: Once a week during homebased exercise regime
|
Complications to training
|
Once a week during homebased exercise regime
|
Quality of life
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).
Tijdsspanne: 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)
Tijdsspanne: 12 months after completion
|
Comparison within and between groups
|
12 months after completion
|
Endurance time
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Bengt Johansson, MD, Phd, Umeå University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GUCHUmU01
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Aangeboren hartafwijkingen
-
University Hospital TuebingenVoltooidHeart Assist-apparaatDuitsland
-
University of ChicagoVoltooidHartfalen | Heart Assist-apparaat | HyponatremischVerenigde Staten
-
Region SkaneAanmelden op uitnodigingHartfalen New York Heart Association (NYHA) Klasse II | Hartfalen New York Heart Association (NYHA) Klasse IIIZweden
-
Carmel Medical CenterOnbekendPneumoperitoneum | Heart Output StoornisIsraël
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... en andere medewerkersNog niet aan het wervenHartfalen, systolisch | Hartfalen met verminderde ejectiefractie | Hartfalen New York Heart Association Klasse IV | Hartfalen New York Heart Association Klasse IIIPolen
-
Triple-Gene, LLCIntrexon Corporation; Precigen, IncVoltooidHart-en vaatziekten | Hartfalen | Heart-Assist-apparaatVerenigde Staten
-
NYU Langone HealthIngetrokkenPacemaker defect | Implanteerbare defibrillator defect
-
University of Illinois at ChicagoNational Eye Institute (NEI); National Institutes of Health (NIH)WervingHoornvlies defect | Hoornvlies | Mesenchymale stromale cellen | Hoornvliesepitheel defectVerenigde Staten
-
AlloSourceNog niet aan het werven
-
Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanWerving
Klinische onderzoeken op Home based interval training
-
Cairo UniversityVoltooidArteriële stijfheidEgypte
-
University of Central LancashireUniversity of HullVoltooidHoge intensiteit interval trainingVerenigd Koninkrijk
-
McMaster UniversityVoltooid
-
Norwegian University of Science and TechnologyVoltooidLongziekte, chronisch obstructiefNoorwegen
-
Hospital de Clinicas de Porto AlegreVoltooidHartfalen | Diastolisch hartfalenBrazilië
-
Rigshospitalet, DenmarkWervingChronische obstructieve longziekteDenemarken
-
Scott G. ThomasTrainerRoad (see TrainerRoad.com)WervingBlijkbaar gezonde fietsprestaties voor volwassenenCanada
-
Hull University Teaching Hospitals NHS TrustUniversity of HullWervingPerifere arteriële ziekte | Claudicatio intermittensVerenigd Koninkrijk
-
Riphah International UniversityVoltooidCognitieve flexibiliteit bij vrouwelijke tienersPakistan
-
Maastricht UniversityVoltooidDiabetes mellitus, type 2 | Insuline-resistentieNederland