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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02228603
Other study ID # 2014/92
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date June 1, 2019

Study information

Verified date August 2019
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
high-intensity exercise training

web-based follow-up program

usual care


Locations

Country Name City State
Norway Levanger Hospital Levanger
Norway St Olavs Hospital Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Levanger Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in peak oxygen uptake measured during exercise on treadmill (MetaMax Cortex/Innocor) 2 years
Secondary physical activity assessed by accelerometer SenseWear Armband Pro 2 years
Secondary quality of life assessed by MacNew Health-related quality of life questionnaire 2 years
Secondary depression assessed by Hospital anxiety and depression scale (HAD) 2 years
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