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Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes

18. juli 2019 oppdatert av: Jeffrey W Christle, Technical University of Munich

A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting

Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. The objective of this study is to translate regular exercise training into a community based setting. A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

From 2011, patients insured at "Techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program. Training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training. The last phase of 12 weeks, supervised training is only once/week. Patients are asked to perform exercise training 3-5 times weekly. At the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn. Training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks. Resistance training starts after 6 weeks and is performed within the supervised training. All patients were offered an individual nutritional counseling.

Studietype

Intervensjonell

Registrering (Forventet)

500

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyskland
      • Munich, Tyskland, 81675
        • Klinikum rechts der Isar/ Technische Universitaet Muenchen

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Exercise training
All patients were included in the exercise training group
Atferdsmessig: Exercise training

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in VO2peak in ml/kg/min
Tidsramme: 6 months
Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
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
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
6 months
Change in Watts at anaerobic threshold RCP
Tidsramme: 6 months
RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
6 months
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
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Technical University of Munich

Etterforskere

  • Studieleder: Martin Halle, Prof., Technical University Munic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2011

Primær fullføring (Forventet)

1. august 2019

Studiet fullført (Forventet)

1. januar 2020

Datoer for studieregistrering

Først innsendt

26. mai 2017

Først innsendt som oppfylte QC-kriteriene

2. juli 2017

Først lagt ut (Faktiske)

6. juli 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 5132/11

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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