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

January 22, 2015 updated by: 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).

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in maximal exercise capacity (watt/kgBW)
Time Frame: six months
six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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