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

22. Januar 2015 aktualisiert von: 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).

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Aktiver 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change from baseline in maximal exercise capacity (watt/kgBW)
Zeitfenster: six months
six months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in maximal exercise capacity (watt/kgBW)
Zeitfenster: 12 months
12 months
Change from baseline in anthropometric measures
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: six and 12 months
six and 12 months
Change in clinical symptoms (NYHA-stage, CCS-stage, number, type and dose of medications))
Zeitfenster: six and 12 months
six and 12 months
Change in physical activity level (based on 7-day accelerometry)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 6 and 12 months
24-hour blood pressure will be measured using a holter BP monitor
6 and 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2011

Primärer Abschluss (Tatsächlich)

1. Januar 2015

Studienabschluss (Tatsächlich)

1. Januar 2015

Studienanmeldedaten

Zuerst eingereicht

5. Juli 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. August 2013

Zuerst gepostet (Schätzen)

13. August 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. Januar 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Januar 2015

Zuletzt verifiziert

1. Januar 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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