NCT01395095

Brief Summary

The objective is to investigate whether in acute coronary syndrome patients the cardiac risk profile will improve with 2 new extended cardiac rehabilitation interventions and if these patients maintain healthier life style habits and a more active life style compared to patients randomized to standard cardiac rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
914

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 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

First Submitted

Initial submission to the registry

July 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

4.5 years

First QC Date

July 14, 2011

Last Update Submit

March 14, 2016

Conditions

Risk Reduction BehaviorLife Style

Keywords

cardiac rehabilitationrisk factorlifestyle

Outcome Measures

Primary Outcomes (1)

  • Reduction of the SCORE Risk Score

    Healthy lifestyle is quantified by the SCORE Risk Score (7). Apart from age, sex, the SCORE includes the modifiable risk factors total cholesterol, HDL cholesterol, systolic blood pressure and smoking status.

    6 months after the intervention

Secondary Outcomes (1)

  • improved physical fitness

    6 months after the intervention

Study Arms (3)

OPTICARE-A

EXPERIMENTAL

Starts 2 weeks after ending standard cardiac rehabilitation (CR) and is based on five phonebased coaching sessions at 6 weeks intervals up to 6 months. Each coaching session includes 5 stages: (1) Asking questions to establish patient's knowledge, attitude and beliefs about their risk factors; (2) Explanation and rationale; (3) Assertiveness training; (4) Goal setting; (5) Reassessment.

Other: rehabilitation+telephonic coaching

OPTICARE-B

ACTIVE COMPARATOR

Standard CR according to the guidelines consisting of (a) 2 times a week exercise program of 1.5 hours during 12 weeks, (b) upon request of the patient: participation in multifactorial lifestyle and risk factor sessions (medical information, dietary advises and emotional advises, information about risk factors, smoking cessation program and stress management sessions)

Other: OPTICARE-B

OPTICARE-C

EXPERIMENTAL

(a) standard CR consisting of 2 times a week exercise program of 1.5 hours during 12 weeks. (b) (mandatory) participation in multifactorial lifestyle and risk factor sessions: i.e. 4 sessions of 2 hours each (medical information, dietary advises, risk factors and emotional advises). If applicable, patients will participate in smoking cessation, dietary and stress management programs . (c) Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counselor during and after completion of rehabilitation. Activity monitors will be used to provide feedback. (d) Additional compulsory supervised multifactorial lifestyle and risk management training sessions of each 2 hours provided at 4, 6 and 12 months.

Other: OPTICARE-C

Interventions

rehabilitation+telephonic coachingOTHER

intervention starts 2 weeks after ending standard CR and is based on five phonebased coaching sessions at 6 weeks intervals up to 6 months. Each coaching session includes 5 stages: (1) Asking questions to establish patient's knowledge, attitude and beliefs about their risk factors; (2) Explanation and rationale; (3) Assertiveness training; (4) Goal setting; (5) Reassessment.

Also known as: cardiac rehabilitation
OPTICARE-A
OPTICARE-BOTHER

standard CR according to the guidelines consisting of (a) 2 times a week exercise program of 1.5 hours during 12 weeks, (b) upon request of the patient: participation in multifactorial lifestyle and risk factor sessions (medical information, dietary advises and emotional advises, information about risk factors, smoking cessation program and stress management sessions).

Also known as: cardiac rehabilitation
OPTICARE-B
OPTICARE-COTHER

(a) standard CR consisting of 2 times a week exercise program of 1.5 hours during 12 weeks. (b) (mandatory) participation in multifactorial lifestyle and risk factor sessions: i.e. 4 sessions of 2 hours each (medical information, dietary advises, risk factors and emotional advises). If applicable, patients will participate in smoking cessation, dietary and stress management programs . (c) Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counselor during and after completion of rehabilitation. Activity monitors will be used to provide feedback. (d) Additional compulsory supervised multifactorial lifestyle and risk management training sessions of each 2 hours provided at 4, 6 and 12 months.

Also known as: cardiac rehabilitation
OPTICARE-C

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an acute coronary syndrome treated with primary or elective PCI or coronary surgery (CABG), with a stable medical condition and providing written informed consent are eligible to participate.
  • Men and women who signed informed consent.
  • Patients are eligible to participate in the study if they are: able to regularly attend a supervised exercise programme and able to complete Dutch language questionnaires.

You may not qualify if:

  • Patients with heart failure
  • Impaired left ventricular function (LVEF\<40%)
  • Psychic or cognitive impairments
  • Severe arrhythmias
  • Heart valve disease
  • Congenital disease
  • Severe co-morbidities which limit the CR (e.g. severe COPD, severe diabetes or locomotive disorder) and patients with an ICD will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capri hartrevalidatie

Rotterdam, 3016 BC, Netherlands

Location

Related Publications (3)

  • den Uijl I, Ter Hoeve N, Sunamura M, Lenzen MJ, Braakhuis HEM, Stam HJ, Boersma E, van den Berg-Emons RJG. Physical Activity and Sedentary Behavior in Cardiac Rehabilitation: Does Body Mass Index Matter? Phys Ther. 2021 Sep 1;101(9):pzab142. doi: 10.1093/ptj/pzab142.

    PMID: 34089325DERIVED

  • de Bakker M, den Uijl I, Ter Hoeve N, van Domburg RT, Geleijnse ML, van den Berg-Emons RJ, Boersma E, Sunamura M. Association Between Exercise Capacity and Health-Related Quality of Life During and After Cardiac Rehabilitation in Acute Coronary Syndrome Patients: A Substudy of the OPTICARE Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Apr;101(4):650-657. doi: 10.1016/j.apmr.2019.11.017. Epub 2020 Jan 2.

    PMID: 31904342DERIVED

  • Sunamura M, Ter Hoeve N, van den Berg-Emons RJG, Geleijnse ML, Haverkamp M, Stam HJ, Boersma E, van Domburg RT. Randomised controlled trial of two advanced and extended cardiac rehabilitation programmes. Heart. 2018 Mar;104(5):430-437. doi: 10.1136/heartjnl-2017-311681. Epub 2017 Sep 27.

    PMID: 28954826DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ron T van Domburg, PhD

    ErasmusMC, Thoraxcenter

    PRINCIPAL INVESTIGATOR

  • Felix Zijlstra, MD, PhD

    ErasmusMC, Thoraxcenter

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 15, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations

NL(1)