- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01921036
The Effects of Combined Exercise Training on Exercise Capacity in Cardiac Rehabilitation (DOPPELHERZ)
Individuell Dosiertes Kraft-ausdauer-training in Ambulanten Herzgruppen - Einfluss Auf Koerperliche Belastbarkeit Von Herzpatienten.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Munich, Germany, 80992
- Klinikum rechts der Isar/ Technische Universitaet Muenchen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Jeffrey W Christle, M.A., Klinikum rechts der Isar
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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