Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial

Kirstine Laerum Sibilitz; Selina Kikkenborg Berg; Tina Birgitte Hansen; Signe Stelling Risom; Trine Bernholdt Rasmussen; Christian Hassager; Lars Køber; Daniel Steinbrüchel; Christian Gluud; Per Winkel; Lau Caspar Thygesen; Jane Lindschou Hansen; Jean Paul Schmid; Viviane Conraads; Barbara Christina Brocki; Ann-Dorthe Zwisler

doi:10.1186/1745-6215-14-104

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeart_VR): study protocol for a randomised clinical trial

Kirstine Laerum Sibilitz, Selina Kikkenborg Berg, Tina Birgitte Hansen, Signe Stelling Risom, Trine Bernholdt Rasmussen, Christian Hassager, Lars Køber, Daniel Steinbrüchel, Christian Gluud, Per Winkel, Lau Caspar Thygesen, Jane Lindschou Hansen, Jean Paul Schmid, Viviane Conraads, Barbara Christina Brocki, Ann-Dorthe Zwisler

17 Citations (Scopus)

Abstract

Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). ClinicalTrials.gov (http://NCT01558765).

Original language	English
Article number	104
Journal	Trials
Volume	14
Pages (from-to)	1-14
Number of pages	14
ISSN	1745-6215
DOIs	https://doi.org/10.1186/1745-6215-14-104
Publication status	Published - 2013

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Sibilitz, K. L., Berg, S. K., Hansen, T. B., Risom, S. S., Rasmussen, T. B., Hassager, C., Køber, L., Steinbrüchel, D., Gluud, C., Winkel, P., Thygesen, L. C., Hansen, J. L., Schmid, J. P., Conraads, V., Brocki, B. C., & Zwisler, A-D. (2013). Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeart_VR): study protocol for a randomised clinical trial. Trials, 14, 1-14. [104]. https://doi.org/10.1186/1745-6215-14-104

Sibilitz, KL, Berg, SK, Hansen, TB, Risom, SS, Rasmussen, TB, Hassager, C , Køber, L, Steinbrüchel, D, Gluud, C, Winkel, P, Thygesen, LC, Hansen, JL, Schmid, JP, Conraads, V, Brocki, BC & Zwisler, A-D 2013, 'Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeart_VR): study protocol for a randomised clinical trial', Trials, vol. 14, 104, pp. 1-14. https://doi.org/10.1186/1745-6215-14-104

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title = "Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial",

abstract = "Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). ClinicalTrials.gov (http://NCT01558765).",

author = "Sibilitz, {Kirstine Laerum} and Berg, {Selina Kikkenborg} and Hansen, {Tina Birgitte} and Risom, {Signe Stelling} and Rasmussen, {Trine Bernholdt} and Christian Hassager and Lars K{\o}ber and Daniel Steinbr{\"u}chel and Christian Gluud and Per Winkel and Thygesen, {Lau Caspar} and Hansen, {Jane Lindschou} and Schmid, {Jean Paul} and Viviane Conraads and Brocki, {Barbara Christina} and Ann-Dorthe Zwisler",

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T2 - study protocol for a randomised clinical trial

AU - Sibilitz, Kirstine Laerum

AU - Berg, Selina Kikkenborg

AU - Hansen, Tina Birgitte

AU - Risom, Signe Stelling

AU - Rasmussen, Trine Bernholdt

AU - Hassager, Christian

AU - Køber, Lars

AU - Steinbrüchel, Daniel

AU - Gluud, Christian

AU - Winkel, Per

AU - Thygesen, Lau Caspar

AU - Hansen, Jane Lindschou

AU - Schmid, Jean Paul

AU - Conraads, Viviane

AU - Brocki, Barbara Christina

AU - Zwisler, Ann-Dorthe

PY - 2013

Y1 - 2013

N2 - Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). ClinicalTrials.gov (http://NCT01558765).

AB - Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). ClinicalTrials.gov (http://NCT01558765).

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