TY - JOUR
T1 - A randomized clinical trial of hospital-based, comprehensive cardiac rehabilitation versus usual care for patients with congestive heart failure, ischemic heart disease or high risk of ischemic heart disease (the DANREHAB Trial) – design, intervention and population.
AU - Zwisler, Anne Dorthe
AU - Schou, Lone Helle
AU - Soja, Anne M.
AU - Brønnum-Hansen, Henrik
AU - Gluud, Christian
AU - Iversen, Lars
AU - Sigurd, Bjarne
AU - Madsen, Mette
AU - Fischer-Hansen, Jørgen
N1 - Funding Information: We thank the patients who participated and the CR staff members who adhered to the philosophy of comprehensive CR. We thank the following for financial support: Copenhagen Hospital Corporation Research Council, Danish Heart Foundation, Danish Pharmacy Foundation of 1991, Danish Research Council, Danish Centre for Evaluation and Health Technology Assessment, Danish Ministry of the Interior and Health, Development Fund of Copenhagen County, Villadsen Family Foundation, Eva and Henry Frænkel's Memorial Foundation, Builder LP Christensen's Foundation, Danish Animal Protection Foundation, Bristol Meyers Squibb, Merck Sharp and Dohme and AstraZeneca.
PY - 2005/11
Y1 - 2005/11
N2 - Background: Current guidelines broadly recommend comprehensive cardiac rehabilitation (CR), although evidence for this is still limited. It is not known whether evidence from before 1995 is still valid. Study Design: The DANish Cardiac ReHABilitation (DANREHAB) trial was designed as a centrally randomized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure, ischemic heart disease, or high risk for ischemic heart disease. A combined primary outcome measure included total mortality, myocardial infarction, or readmissions due to heart disease based on linkage to public registries. The CR was an individually tailored, multidisciplinary program (6 weeks of intensive CR and 12 months of follow-up) including patient education, exercise training, dietary counseling, smoking cessation, psychosocial support, risk factor management, and clinical assessment. Study Population: Of 5060 discharged patients, 1614 (32%) were eligible for the trial and 770 patients were randomized (47% of those eligible). Participants were younger (P < .001) and had less comorbidity than nonparticipants (P < .03). Conclusion: Our trial shows that a large-scale, centrally randomized clinical trial on comprehensive CR can be conducted among a broadly defined patient group, but reaching the stipulated number of 1800 patients was difficult. Although the study included relatively many women and older people, elderly patients and patients with high comorbidity were underrepresented, which may influence the external validity.
AB - Background: Current guidelines broadly recommend comprehensive cardiac rehabilitation (CR), although evidence for this is still limited. It is not known whether evidence from before 1995 is still valid. Study Design: The DANish Cardiac ReHABilitation (DANREHAB) trial was designed as a centrally randomized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure, ischemic heart disease, or high risk for ischemic heart disease. A combined primary outcome measure included total mortality, myocardial infarction, or readmissions due to heart disease based on linkage to public registries. The CR was an individually tailored, multidisciplinary program (6 weeks of intensive CR and 12 months of follow-up) including patient education, exercise training, dietary counseling, smoking cessation, psychosocial support, risk factor management, and clinical assessment. Study Population: Of 5060 discharged patients, 1614 (32%) were eligible for the trial and 770 patients were randomized (47% of those eligible). Participants were younger (P < .001) and had less comorbidity than nonparticipants (P < .03). Conclusion: Our trial shows that a large-scale, centrally randomized clinical trial on comprehensive CR can be conducted among a broadly defined patient group, but reaching the stipulated number of 1800 patients was difficult. Although the study included relatively many women and older people, elderly patients and patients with high comorbidity were underrepresented, which may influence the external validity.
UR - http://www.scopus.com/inward/record.url?scp=27744551053&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2005.06.010
DO - 10.1016/j.ahj.2005.06.010
M3 - Journal article
SN - 0002-8703
VL - 150
SP - 899.e7-899.e16
JO - American Heart Journal
JF - American Heart Journal
IS - 5
ER -