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Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol.

Pedersen LR, Olsen RH, Frederiksen M, Astrup A, Chabanova E, Hasbak P, Holst JJ, Kjær A, Newman JW, Walzem R, Wisløff U, Sajadieh A, Haugaard SB, Prescott E - BMC Cardiovasc Disord (2013)

Bottom Line: Secondary endpoints include cardiovascular, metabolic, inflammatory and anthropometric measures.The study will compare the short and long-term effects of a protocol consisting of AIT alone or a rapid weight loss followed by AIT.We wish to contribute to the creation of effective secondary prevention and sustainable rehabilitation strategies in the large population of overweight and obese patients diagnosed with CAD.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark. lrpedersen@gmail.com.

ABSTRACT

Background: Coronary artery disease (CAD) is accountable for more than 7 million deaths each year according to the World Health Organization (WHO). In a European population 80% of patients diagnosed with CAD are overweight and 31% are obese. Physical inactivity and overweight are major risk factors in CAD, thus central strategies in secondary prevention are increased physical activity and weight loss.

Methods/design: In a randomized controlled trial 70 participants with stable CAD, age 45-75, body mass index 28-40 kg/m2 and no diabetes are randomized (1:1) to 12 weeks of intensive exercise or weight loss both succeeded by a 40-week follow-up. The exercise protocol consist of supervised aerobic interval training (AIT) at 85-90% of VO2peak 3 times weekly for 12 weeks followed by supervised AIT twice weekly for 40 weeks. In the weight loss arm dieticians instruct the participants in a low energy diet (800-1000 kcal/day) for 12 weeks, followed by 40 weeks of weight maintenance combined with supervised AIT twice weekly. The primary endpoint of the study is change in coronary flow reserve after the first 12 weeks' intervention. Secondary endpoints include cardiovascular, metabolic, inflammatory and anthropometric measures.

Discussion: The study will compare the short and long-term effects of a protocol consisting of AIT alone or a rapid weight loss followed by AIT. Additionally, it will provide new insight in mechanisms behind the benefits of exercise and weight loss. We wish to contribute to the creation of effective secondary prevention and sustainable rehabilitation strategies in the large population of overweight and obese patients diagnosed with CAD.

Trial registration: ClinicalTrials.gov: NCT01724567.

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Related in: MedlinePlus

Study design and inclusion.
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Figure 1: Study design and inclusion.

Mentions: Participants were included in the study from September 2011 to April 2013. The study is on-going and the last participants will be evaluated in April 2014. We included 70 patients (Figure 1) with stable CAD; age 45–75 years, BMI 28–40 kg/m2 not diagnosed with diabetes. Further inclusion and exclusion criteria are listed in Table 1. The participants were found through the coronary rehabilitation unit at Bispebjerg University Hospital and a registry of coronary angiography, which comprises all angiographies performed in the Danish Capital Region. If the medical record did not reveal any exclusion criteria, a letter of invitation was sent with written information about the trial. People interested in participation were invited to a screening visit, conducted by a medical doctor connected to the study, where they received information about the study orally. To screen for certain exclusion criteria echocardiography and cardiopulmonary exercise test (CPET) including ECG were performed. Furthermore, blood samples were taken to screen for diabetes, kidney- and liver disease. If eligible and still interested the participant signed informed consent.


Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol.

Pedersen LR, Olsen RH, Frederiksen M, Astrup A, Chabanova E, Hasbak P, Holst JJ, Kjær A, Newman JW, Walzem R, Wisløff U, Sajadieh A, Haugaard SB, Prescott E - BMC Cardiovasc Disord (2013)

Study design and inclusion.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4225526&req=5

Figure 1: Study design and inclusion.
Mentions: Participants were included in the study from September 2011 to April 2013. The study is on-going and the last participants will be evaluated in April 2014. We included 70 patients (Figure 1) with stable CAD; age 45–75 years, BMI 28–40 kg/m2 not diagnosed with diabetes. Further inclusion and exclusion criteria are listed in Table 1. The participants were found through the coronary rehabilitation unit at Bispebjerg University Hospital and a registry of coronary angiography, which comprises all angiographies performed in the Danish Capital Region. If the medical record did not reveal any exclusion criteria, a letter of invitation was sent with written information about the trial. People interested in participation were invited to a screening visit, conducted by a medical doctor connected to the study, where they received information about the study orally. To screen for certain exclusion criteria echocardiography and cardiopulmonary exercise test (CPET) including ECG were performed. Furthermore, blood samples were taken to screen for diabetes, kidney- and liver disease. If eligible and still interested the participant signed informed consent.

Bottom Line: Secondary endpoints include cardiovascular, metabolic, inflammatory and anthropometric measures.The study will compare the short and long-term effects of a protocol consisting of AIT alone or a rapid weight loss followed by AIT.We wish to contribute to the creation of effective secondary prevention and sustainable rehabilitation strategies in the large population of overweight and obese patients diagnosed with CAD.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark. lrpedersen@gmail.com.

ABSTRACT

Background: Coronary artery disease (CAD) is accountable for more than 7 million deaths each year according to the World Health Organization (WHO). In a European population 80% of patients diagnosed with CAD are overweight and 31% are obese. Physical inactivity and overweight are major risk factors in CAD, thus central strategies in secondary prevention are increased physical activity and weight loss.

Methods/design: In a randomized controlled trial 70 participants with stable CAD, age 45-75, body mass index 28-40 kg/m2 and no diabetes are randomized (1:1) to 12 weeks of intensive exercise or weight loss both succeeded by a 40-week follow-up. The exercise protocol consist of supervised aerobic interval training (AIT) at 85-90% of VO2peak 3 times weekly for 12 weeks followed by supervised AIT twice weekly for 40 weeks. In the weight loss arm dieticians instruct the participants in a low energy diet (800-1000 kcal/day) for 12 weeks, followed by 40 weeks of weight maintenance combined with supervised AIT twice weekly. The primary endpoint of the study is change in coronary flow reserve after the first 12 weeks' intervention. Secondary endpoints include cardiovascular, metabolic, inflammatory and anthropometric measures.

Discussion: The study will compare the short and long-term effects of a protocol consisting of AIT alone or a rapid weight loss followed by AIT. Additionally, it will provide new insight in mechanisms behind the benefits of exercise and weight loss. We wish to contribute to the creation of effective secondary prevention and sustainable rehabilitation strategies in the large population of overweight and obese patients diagnosed with CAD.

Trial registration: ClinicalTrials.gov: NCT01724567.

Show MeSH
Related in: MedlinePlus