Exercise as a Life-long Medicine in Patients With Coronar... | NCT02228603

Studies
Exercise as a Life-long Medicine in Patients With Coronary Artery Disease

NCT02228603

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Aug 30, 2019Actual

Enrollment

161Actual

Phase

Not Applicable

Conditions

Cardiovascular Diseases
Myocardial Infarction
Angina (Stable)

Interventions

high-intensity exercise training
web-based follow-up program
usual care

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014Actual

Primary Completion Date

Jun 1, 2019Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Aug 27, 2014

First Submission Date that Met QC Criteria

Aug 27, 2014

First Posted Date

Aug 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2019

Last Update Posted Date

Aug 30, 2019Actual

Name	Class
St. Olavs Hospital	OTHER
Helse Nord-Trøndelag HF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes.

The aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high-intensity exercise	Experimental	community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months	Behavioral: high-intensity exercise training
web-based follow-up	Active Comparator	web-based follow-up program: home-based group will be followed up by mail and telephone calls the first 8 weeks, then every third month for 12 months	Behavioral: web-based follow-up program
control	Other	control group will receive usual care: information about recommended physical activity and healthy lifestyle	Behavioral: usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high-intensity exercise training	Behavioral		high-intensity exercise
web-based follow-up program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in peak oxygen uptake	measured during exercise on treadmill (MetaMax Cortex/Innocor)	2 years

Secondary Outcomes

Measure	Description	Time Frame
physical activity	assessed by accelerometer SenseWear Armband Pro	2 years
quality of life	assessed by MacNew Health-related quality of life questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

myocardial infarction, stable angina, heart surgery
finished phase 2 cardiac rehabilitation
clinically stable
able to communicate in Norwegian
able to do a maximal treadmill test

Exclusion Criteria:

unstable angina
serious cardiac arrhythmia
serious heart valve insufficiency
heart failure
any contraindication for high intensity exercise training
participation in other exercise study
pregnancy
cognitive impairment
drug abuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asbjørn Støylen, prof	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Levanger Hospital		Levanger			Norway
St Olavs Hospital

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D009203	Myocardial Infarction
D060050	Angina, Stable

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D014652	Vascular Diseases
D007238	Infarction

Browse Leaves

Not provided

Browse Branches

Not provided