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Influence of Exercise Therapy on Insulin Resistance in Patients With Heart Failure

8. december 2013 opdateret af: Bert Op't Eijnde, Hasselt University

The purpose of this study is to investigate the effects of a combined training programme on insulin resistance, exercise tolerance, muscle strength, body composition and cardiac function in chronic heart failure patients.

It is assumed that the above mentioned clinical parameters will improve due to physical exercise.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. Background and study aims During the last decades, the prevalence of (pre)diabetes but also of chronic heart failure (CHF) has increased dramatically. Somehow, both conditions are linked, but the mechanisms involved have not been completely clarified yet. It is clear that the presence of (pre)diabetes in CHF patients affects morbidity and mortality. Although feasibility, safety and beneficial effects of exercise training in CHF are generally acknowledged, its effects on insulin resistance are not well understood. Therefore, the presented study aims to investigate the effect of ET on insulin resistance and the possible link with cardiac function, exercise tolerance, muscle strength and body composition in CHF patients.

  2. What does the study involve?

    A randomized controlled study (n=30) will be performed over a period of 12 weeks. Following study inclusion, baseline measurements will be performed in 1 week. They include:

    • a maximal exercise test on a bicycle ergometer to assess exercise tolerance,
    • two oral glucose tolerance tests to assess fasting and post-exercise insulin resistance,
    • a venous blood sample to determine HbA1c, blood lipids, BNP,
    • a muscle strength measurement on a isokinetic dynamometer,
    • assessment of body composition via dual energy x-ray absorptiometry,
    • cardiac echography,
    • questionnaires to assess health-related quality of life,
    • a questionnaire (IPAQ) and a pedometer (3 days) to assess physical activity. Following baseline measurements, subjects will be randomized to a control group (CON, n=10) and an exercise intervention group (EX, n=20), matching for gender and reduced/preserved ejection fraction and glucose tolerance. Hereafter, CON will receive usual care and will be advised to maintain their normal lifestyle, EX subjects will be enrolled in a 12-week training program. Following 6 (MID) and 12 (POST) weeks of exercise training including progressive training load adaptations, baseline measurements will be repeated in all patients.

  3. What are the possible benefits and risks of participating?

    • Benefits: patients receive a free training program with personal and professional supervision. After completing the study, they receive a report with personal results and evaluation of training effects.
    • Risks: the usual risks of exercise tolerance testing and exercise training in a CHF population are limited because training sessions are held in the supervised conditions of the Jessa hospital and because training characteristics are according to guidelines of the European Society of Cardiology. Exposure to x-rays during body composition assessment is very low, almost negligible.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

29

Fase

  • Ikke anvendelig

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosis of chronic heart failure for at least 6 months
  • clinically stable (not hospitalized) for more than 3 months prior to the onset of the study
  • optimal medical therapy.

Exclusion Criteria:

  • any contra-indication for exercise therapy,
  • glucose lowering medical therapy,
  • active lifestyle with regular physical activity.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: training
12 weeks (2 x 6 weeks) of combined exercise training programme (supervised)
Andet: uddannelse
Andre navne:
  • 12 weeks of combined exercise training
Ingen indgriben: Control
Continued usual care, habitual lifestyle

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
insulin sensitivity (insulin profile)
Tidsramme: change from baseline to 12 weeks
glucose and insulin concentration measurements in blood during oral glucose tolerance test
change from baseline to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exercise tolerance
Tidsramme: change from baseline to 12 weeks
maximal cardiopulmonary exercise test on a bicycle ergometer
change from baseline to 12 weeks
HbA1c, blood lipids, BNP
Tidsramme: change from baseline to 12 weeks
change from baseline to 12 weeks
Muscle strength
Tidsramme: change from baseline to 12 weeks
maximal strength and strength endurance tested on a isokinetic dynamometer
change from baseline to 12 weeks
Body composition
Tidsramme: change from baseline to 12 weeks
dual energy x-ray absorptiometry
change from baseline to 12 weeks
cardiac function
Tidsramme: change from baseline to 12 weeks
echocardiography
change from baseline to 12 weeks
Health-related quality of life
Tidsramme: change from baseline to 12 weeks
MLHFQ and Eq5d
change from baseline to 12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Hasselt University

Samarbejdspartnere

Jessa Hospital

Efterforskere

  • Studiestol: An Stevens, dra., Hasselt 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. april 2011

Primær færdiggørelse (Faktiske)

1. juni 2011

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

27. november 2013

Først indsendt, der opfyldte QC-kriterier

27. november 2013

Først opslået (Skøn)

4. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11.11/cardio11.01

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