NCT02228603

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

2 active sites

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

August 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

4.8 years

First QC Date

August 27, 2014

Last Update Submit

August 28, 2019

Conditions

Keywords

exercise therapyrehabilitation

Outcome Measures

Primary Outcomes (1)

  • change in peak oxygen uptake

    measured during exercise on treadmill (MetaMax Cortex/Innocor)

    2 years

Secondary Outcomes (3)

  • physical activity

    2 years

  • quality of life

    2 years

  • depression

    2 years

Study Arms (3)

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

high-intensity exercise
web-based follow-up
usual careBEHAVIORAL
control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Levanger Hospital

Levanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial InfarctionAngina, Stable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Asbjørn Støylen, prof

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 29, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations