- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03208751
Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Munich, Tyskland, 81675
- Klinikum rechts der Isar/ Technische Universitaet Muenchen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Coronary artery disease and/or diabetes mellitus
- Heart failure
Exclusion Criteria:
- all conditions which are not compatible with exercise training:
- severe orthopedic disorders
- severe psychiatric disease
- severe valve insufficiency
- presence of myocardial ischemia (decision made by cardiologist)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Exercise training
All patients were included in the exercise training group
|
Exercise intervention was divided into 3 phases: Phase 1: 6 weeks of moderate continuous training (MCT) 20 to 40 minutes at intensity of 60% of VO2peak, 3 times/week Phase 2: 6 weeks of moderate intensity interval training (MIIT) 30-40 min, intensity 60 to 80% of VO2peak, twice weekly plus at least once weekly MCT home based training Phase 3 (after performing new exercise testing to adapt training intensities): 12 weeks of MIIT 40 min once/week, intensity 60-80/85% of VO2peak, plus at least twice weekly home based MCT. From phase 2, supervised sessions included resistance training of at least 3 muscle groups, 3x15 repetitions at moderate intensity (Borg 12-14). Nutritional counseling is offered up to 4 times in 6 months on an individual basis. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in VO2peak in ml/kg/min
Tidsramme: 6 months
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Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
|
6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in HbA1c for patients with diabetes
Tidsramme: 6 months
|
Glycated hemoglobin >5,7 corresponds to glucose intolerance, > 6,5 is diagnosed diabetes mellitus
|
6 months
|
Change in hsCRP
Tidsramme: 6 months
|
high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events
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6 months
|
Change in E/e'
Tidsramme: 6 months
|
E/e' is an echocardiographic marker for diastolic function, an E/e' < 8 is considered as normal
|
6 months
|
Change in quality of life measured by SF-36
Tidsramme: 6 months
|
The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured
|
6 months
|
Change in insulin IU
Tidsramme: 6 months
|
Insulin dosage is measured in IE (international units)
|
6 months
|
Change in HDL- and LDL- cholesterol as well as triglycerides
Tidsramme: 6 months
|
all measured in mg/dl
|
6 months
|
Change in Adiponectin
Tidsramme: 6 months
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Adiponectin is an adipokine which is released by fat tissue
|
6 months
|
Change in Watts at anaerobic threshold VAT
Tidsramme: 6 months
|
VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing
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6 months
|
Change in Watts at anaerobic threshold RCP
Tidsramme: 6 months
|
RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
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6 months
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Change in max. Watts
Tidsramme: 6 months
|
On bicycle ergometry, Watts are measured
|
6 months
|
Change in max. Watts/kg bodyweight
Tidsramme: 6 months
|
max.
Watts indexed b body weight
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6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Martin Halle, Prof., Technical University Munic
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5132/11
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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