Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003625

Trial Description

start of 1:1-Block title

Title

The effect of individually prescribed combined exercise training on physical capacity in cardiac rehabilitation patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

DOPPELHERZ

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Scientific Background: Based on well validated studies, high exercise capacity leads to longer life expectancy in cardaic patients. An especially good way to improve exercise capacity is participation in individuallized regular resistance and endurance exercise training.
Hypothesis: In secondary cardiac rehabilitation patients with limited physical exercise capacity (< 1.4 Watt/kg maximum at cycle-ergometric exercise testing), a individually prescribed exercise program focusing on strength and endurance exercise will lead to greater improvements in exercise capacity then current cardiac rehabilitation.
Participants: Cardiac patients in cardiac rehabilitation with low exercise capacity (< 1.4 Watt/kg body weight)
Goals: As well as cardiac rehabilitation training, we are offering a individuallized strength and endurance training program, and therefore hope to combine the advantages of both forms of training.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In secondary cardiac rehabilitation patients with limited physical exercise capacity (< 1.4 Watt/kg maximum at cycle-ergometric exercise testing), a individually prescribed exercise program focusing on strength and endurance exercise will lead to greater improvements in exercise capacity then current cardiac rehabilitation.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003625
  •   2012/03/19
  •   [---]*
  •   yes
  •   Approved
  •   2931/10, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I70 -  Atherosclerosis
  •   I10 -  Essential (primary) hypertension
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention: The intervention-group, to test the primary endpoint of the study, trains once a week in the conventional cardiac rehabilitation group, but also trains once a week in an individuallized moderate resistance and endurance training group in the institute's training room. The intervention- phase lasts six months. Immediately after the conclusion of the intervention phase, the participants are to continue conventional cardiac rehabilitation for a further six months, at which point a final examination will be performed.
  •   Control (conventional cardiac rehabilitation)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Change in exercise capacity after six months, measured as maximal watts achieved during exercise testing per kilogram of body weight (Watt/kgBW).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Cardiovascular risk-profile (6 and 12 months after beginning the intervention)
Quality of Life (QoL) (6 and 12 months after beginning the intervention )
Safety (SAE/AE) (6 and 12 months after beginning the intervention)
Physical Activity Level (PAL) (6 and 12 months after beginning the intervention)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/02/01
  •   70
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Participation in secondary outpatient cardiac rehabilitation
Written informed consent
Physian approval of supervised physical activity
Exercise capacity < 1.4 Watt/kgBW measured within 12 weeks before beginning participation in the study

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Maximum exercise capacity > 1.4 Watt/kg BW
Contraindication for regular supervised exercise
High-grade aortic valve stenosis
NYHA IV Heart Failure
Uncontrolled hypertension
Uncontrolled diabetes
Hospitalisation for cardiac symptoms within six weeks
Acute systemic disease/ fever
Chronic drug/ alcohol abuse
Inability/unwillingness to understand/participate in all aspects of the study
Rejection of participant by the study center

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Präventive und Rehabilitative Sportmedizin Klinikum rechts der Isar/ Technische Universität München (TUM)
    • Mr.  Prof Dr. med.   Martin   Halle 
    • Georg-Brauchle-Ring 56 (Campus C)
    • D-80992  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Präventive und Rehabilitative Sportmedizin Klinikum recht der Isar/Technische Universität München (TUM)
    • Mr.  Jeffrey Wilcox  Christle 
    • Georg-Brauchle-Ring 56 (Campus C)
    • 80992  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Präventive und Rehabilitative Sportmedizin Klinikum recht der Isar/Technische Universität München (TUM)
    • Mr.  Jeffrey Wilcox  Christle 
    • Georg-Brauchle-Ring 56 (Campus C)
    • 80992  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Landes-Arbeitsgemeinschaft für kardiologische Prävention und Rehabilitation in Bayern e.V. (Herz-LAG Bayern)
    • Höhenried 2
    • 82347  Bernried am Starnberger See
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.