The Effects of Combined Exercise Training on Exercise Capacity in Cardiac Rehabilitation (DOPPELHERZ)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01921036|
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: traditional cardiac rehabilitation Procedure: combined exercise||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Individuell Dosiertes Kraft-ausdauer-training in Ambulanten Herzgruppen - Einfluss Auf Koerperliche Belastbarkeit Von Herzpatienten.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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
Procedure: combined exercise
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.
Procedure: traditional cardiac rehabilitation
mutifactoral cardiac rehabilitation
- Change from baseline in maximal exercise capacity (watt/kgBW) [ Time Frame: six months ]
- Change from baseline in maximal exercise capacity (watt/kgBW) [ Time Frame: 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.
- 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)
- Number of patients with adverse events (AE; documented) [ Time Frame: six and 12 months ]
- Change in clinical symptoms (NYHA-stage, CCS-stage, number, type and dose of medications)) [ Time Frame: 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
- 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.
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921036
|Klinikum rechts der Isar/ Technische Universitaet Muenchen|
|Munich, Germany, 80992|
|Principal Investigator:||Jeffrey W Christle, M.A.||Klinikum rechts der Isar|