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The Effects of Combined Exercise Training on Exercise Capacity in Cardiac Rehabilitation (DOPPELHERZ)

22. januar 2015 opdateret af: Technical University of Munich

Individuell Dosiertes Kraft-ausdauer-training in Ambulanten Herzgruppen - Einfluss Auf Koerperliche Belastbarkeit Von Herzpatienten.

Seventy patients in cardiac rehabilitation with maximal exercise capacity less than 1.4 watt per kilogram bodyweight will be randomized 1:1 into either an intervention training (IN) group or usual care (UC). The IN patients will perform supervised endurance and resistance exercise for approximately 90 minutes once a week and traditional cardiac rehabilitation (TCR) once a week; the UC patients will perform TCR twice a week. The intervention is planned for six months with a follow-up of a further six months. The primary investigation is differences between IN and UC with regard to changes in exercise capacity (max watt/kgBW).

Studieoversigt

Detaljeret beskrivelse

The DOPPELHERZ (The influence of individualized resistance-endurance exercise training on maximal power output in outpatient cardiac rehabilitation) randomized controlled trial was performed at the Department of Prevention and Sports Medicine, Klinikum rechts der Isar in Munich, Germany. 70 patients eligible for and/or participating in cardiac rehabilitation were randomized to six months in an individualized combined exercise group (ICE) or group- based cardiac rehabilitation (GCR), considered usual care in this patient population.

All patients gave written informed consent, the study protocol was approved by the local university hospital ethics committee, all procedures were conducted according to the Declaration of Helsinki.

Participants: All patients were American Heart Association Class "C" (moderate to high risk) based on the presence of cardiac disease and maximal power output of <5 METs (corresponding to <1.4 W/kg body weight), who met eligibility criteria for CR at the time of recruitment. Patients with decompensated or highly symptomatic (NYHA IV) heart failure, acute illness or injury, cardiac hospitalizations within six weeks of inclusion, drug abuse, unstable blood pressure or arrhythmias, high grade valve stenosis or instable diabetes mellitus were excluded.

Primary endpoint: The primary endpoint was change in maximal relative power output (W/kg) measured by CPX after six months.

Exercise training program In both the intervention and usual care arms of the study, exercise training was prescribed twice weekly over a period of six months, and all exercise sessions were led by certified exercise instructors and monitored by physicians.

Group-based cardiac rehabilitation (GCR): The GCR group performed regular exercise in a state-sanctioned cardiac rehabilitation group. This form of GCR is considered Phase III aftercare and has been described elsewhere9. Briefly, GCR patients received moderate-intensity heart rate targets from exercise cardiologists based on CPX results. The group-based program is offered for 90 minutes twice a week and is a combination of gymnastics (including endurance and resistance components), coordination and flexibility exercises, and includes educational components targeting diet and nutrition, stress and relaxation, methods for coping with CVD and behavioral and lifestyle change. The GCR sessions were conducted at a local university gymnasium and were performed in groups of up to 15 participants, as recommended by the German Federal Association for Rehabilitation.

Individualized combined exercise (ICE): The ICE group participated in once-weekly individualized combined resistance-endurance exercise training for 60 minutes and once-weekly traditional group-based cardiac rehabilitation as described above. The ICE intervention included 30 minutes of endurance exercise at 60-70% VO2peak and RPE 11-14 and five resistance exercises (chest press, leg press, lat pull-downs, shoulder press and seated cable row) following the recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation (DGPR) and targeting the large muscle groups at an RPE<16. For the first three months, patients performed two sets of 12-25 repetitions at 30-50% 1RM; after three months patients were retested and thereafter performed two sets of 8-15 repetitions at 40-60% 1RM. The ICE sessions were located at the university sports medicine rehabilitation center and performed in groups of not more than four patients. They were instructed at a maximum 2:1 participant to therapist ratio.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

      • Munich, Tyskland, 80992
        • Klinikum rechts der Isar/ Technische Universitaet Muenchen

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:

  • participation in cardiac rehabilitation
  • written consent
  • < 1.4 watt/kgBW exercise capacity not more than 12 weeks before study begin

Exclusion Criteria:

  • >= 1.4 watt/kgBW
  • contraindications to exercise participation
  • hospitalized for CVD within six weeks of inclusion
  • acute illness/injury (e.g. fever)
  • chronic drug abuse
  • inability to understand study instructions
  • unwillingness to participate

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: combined exercise
90 minutes combined endurance and resistance exercise once a week plus 90 minutes traditional cardiac rehabilitation once a week over six months
Moderate endurance and resistance exercise once a week over six months
Aktiv komparator: traditional cardiac rehabilitation
The group-based program is offered for 90 minutes twice a week and is a combination of gymnastics, coordination and flexibility exercises, and includes educational components targeting diet and nutrition, stress and relaxation, methods for coping with CVD and behavioral and lifestyle change.
mutifactoral cardiac rehabilitation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in maximal exercise capacity (watt/kgBW)
Tidsramme: six months
six months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in maximal exercise capacity (watt/kgBW)
Tidsramme: 12 months
12 months
Change from baseline in anthropometric measures
Tidsramme: six and 12 months
Change from baseline in waist to hip circumference ratio, body mass index, percent body fat and weight.
six and 12 months
Change from baseline in Health Relates Quality of Life (HRQoL as measured by questionnaires)
Tidsramme: six and 12 months
Questionnaires used: Short From 36 (SF-36), Global Mood Scale (GMS), MacNew Heart Disease Quality of Life Instrument (MacNew)
six and 12 months
Number of patients with adverse events (AE; documented)
Tidsramme: six and 12 months
six and 12 months
Change in clinical symptoms (NYHA-stage, CCS-stage, number, type and dose of medications))
Tidsramme: six and 12 months
six and 12 months
Change in physical activity level (based on 7-day accelerometry)
Tidsramme: six and 12 months
Patients will wear accelerometers for 7 days at baseline, 6 months and 12 months, and the change in physical activity level will be calculated
six and 12 months
Change from baseline in upper and lower body muscular strength (1RM; kg)
Tidsramme: six and 12 months
Upper and lower body muscular strength will be measured using a chest press and a leg extension device, respectively.
six and 12 months
Change from baseline in anthropometric measures
Tidsramme: six and 12 months
Change from baseline in waist to hip circumference ratio, body mass index (BMI), percent body fat (%) and weight (kg).
six and 12 months
Change from baseline in blood pressure (Systolic and Dystolic;mmHg)
Tidsramme: 6 and 12 months
24-hour blood pressure will be measured using a holter BP monitor
6 and 12 months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Jeffrey W Christle, M.A., Klinikum rechts der Isar

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. februar 2011

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

5. juli 2013

Først indsendt, der opfyldte QC-kriterier

8. august 2013

Først opslået (Skøn)

13. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. januar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. januar 2015

Sidst verificeret

1. januar 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2931/10
  • DRKS00003625 (Registry Identifier: German Clinical Trials Register)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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