NCT01724567

Brief Summary

The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

2.6 years

First QC Date

October 26, 2012

Last Update Submit

August 3, 2014

Conditions

Ischemic Heart DiseaseObesity

Keywords

Interval TrainingWeight LossSecondary PreventionRehabilitationCardiovascular Risk Factors

Outcome Measures

Primary Outcomes (1)

  • Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period

    Assessed by a non-invasive echocardiographic Doppler measurement

    0, 12 and 52 weeks

Secondary Outcomes (13)

  • Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period

    0, 12 and 52 weeks

  • Change in endothelial function following the diet or training intervention and a maintenance period

    0, 12 and 52 weeks

  • Change in systolic and diastolic function following the diet or training intervention and a maintenance period

    0, 12 and 52 weeks

  • Change in body composition following the diet or training intervention and a maintenance period

    0, 12 and 52 weeks

  • Change in myocardial blood flow following the diet or training intervention and a maintenance period

    0, 12 and 52 weeks

  • +8 more secondary outcomes

Study Arms (2)

Weight Loss

EXPERIMENTAL

12 weeks of Low Calorie Diet to obtain a 10 - 15 % weight loss. Followed by 40 weeks on a weight maintenance diet and interval training 2 times a week.

Other: Weight Loss

Interval Training

EXPERIMENTAL

12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week.

Other: Interval Training

Interventions

Interval TrainingOTHER

Interval training (IT) on an exercise bike 3 times a week, for the first 12 weeks, followed by 40 weeks of IT 2 times a week on exercise bike. Each training session consists of active intervals with a total duration of 16 minutes (durations intervals between 1 and 4 minutes) at 90% of maximal heart rate. Active intervals are separated by active pauses at 60% of maximal heart rate.

Interval Training
Weight LossOTHER

Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.

Weight Loss

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable Ischemic Heart Disease
  • BMI 28 - 40 kg/m2

You may not qualify if:

  • Known Diabetes Mellitus
  • Repeated Fasting plasma glucose ≥ 7 mmol/L or Hba1c \> 7 %
  • Severe or moderate valve disease
  • Main stem stenosis
  • Severe heart failure, Ejection Fraction \< 35 %
  • Physical or mental disability which are expected to prevent completion of intervention
  • Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 \< 50 % of expected) or asthma
  • Active cancer
  • Severe kidney (GFR \< 40 ml/hour) or severe liver disease
  • Severe ischemia or arrhythmias during exercise test
  • \. or 3. degree atrio-ventricular (AV) block, not protected by pacemaker
  • Not able to comprehend written and oral informed consent
  • Hormone treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (6)

  • Pedersen LR, Olsen RH, Frederiksen M, Astrup A, Chabanova E, Hasbak P, Holst JJ, Kjaer A, Newman JW, Walzem R, Wisloff U, Sajadieh A, Haugaard SB, Prescott E. Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol. BMC Cardiovasc Disord. 2013 Nov 19;13:106. doi: 10.1186/1471-2261-13-106.

    PMID: 24252596BACKGROUND

  • Pedersen LR, Olsen RH, Jurs A, Astrup A, Chabanova E, Simonsen L, Wisloff U, Haugaard SB, Prescott E. A randomised trial comparing weight loss with aerobic exercise in overweight individuals with coronary artery disease: The CUT-IT trial. Eur J Prev Cardiol. 2015 Aug;22(8):1009-17. doi: 10.1177/2047487314545280. Epub 2014 Jul 31.

    PMID: 25082954BACKGROUND

  • Pedersen LR, Olsen RH, Anholm C, Astrup A, Eugen-Olsen J, Fenger M, Simonsen L, Walzem RL, Haugaard SB, Prescott E. Effects of 1 year of exercise training versus combined exercise training and weight loss on body composition, low-grade inflammation and lipids in overweight patients with coronary artery disease: a randomized trial. Cardiovasc Diabetol. 2019 Oct 1;18(1):127. doi: 10.1186/s12933-019-0934-x.

    PMID: 31575375DERIVED

  • Pedersen LR, Olsen RH, Anholm C, Walzem RL, Fenger M, Eugen-Olsen J, Haugaard SB, Prescott E. Weight loss is superior to exercise in improving the atherogenic lipid profile in a sedentary, overweight population with stable coronary artery disease: A randomized trial. Atherosclerosis. 2016 Mar;246:221-8. doi: 10.1016/j.atherosclerosis.2016.01.001. Epub 2016 Jan 13.

    PMID: 26803431DERIVED

  • Pedersen LR, Olsen RH, Jurs A, Anholm C, Fenger M, Haugaard SB, Prescott E. A randomized trial comparing the effect of weight loss and exercise training on insulin sensitivity and glucose metabolism in coronary artery disease. Metabolism. 2015 Oct;64(10):1298-307. doi: 10.1016/j.metabol.2015.07.007. Epub 2015 Jul 17.

    PMID: 26296452DERIVED

  • Olsen RH, Pedersen LR, Jurs A, Snoer M, Haugaard SB, Prescott E. A randomised trial comparing the effect of exercise training and weight loss on microvascular function in coronary artery disease. Int J Cardiol. 2015 Apr 15;185:229-35. doi: 10.1016/j.ijcard.2015.03.118. Epub 2015 Mar 11.

    PMID: 25802037DERIVED

MeSH Terms

Conditions

Myocardial IschemiaObesityWeight Loss

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eva Prescott, MD, DMsc

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, MDsc

Study Record Dates

First Submitted

October 26, 2012

First Posted

November 12, 2012

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

DK(1)