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Aerobic Interval Training in Cardiac Rehabilitation

Primary Purpose

Myocardial Infarction, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring rehabilitation outcome, cardiac patients, exercise intensity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • coronary artery disease
  • age over 18
  • referred to cardiac rehabilitation
  • exercise tolerance demonstrated

Exclusion Criteria:

  • severe arrhythmia
  • heart failure
  • drug abuse
  • pregnancy

Sites / Locations

  • St.Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Treadmill group

Exercise groups

home-based exercise

Arm Description

Interval exercise performed on treadmills, supervised

Supervised and organised in groups of ten

Interval training at home, free choice of modality

Outcomes

Primary Outcome Measures

VO2peak

Secondary Outcome Measures

quality of life

Full Information

First Posted
August 21, 2009
Last Updated
March 20, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00964067
Brief Title
Aerobic Interval Training in Cardiac Rehabilitation
Official Title
Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.
Detailed Description
Cardiac rehabilitation is usually first offered in hospitals, but there are several studies that show that home-based rehabilitation is equally efficient. How this comes out when exercise is organized as aerobic interval training is not known.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Disease
Keywords
rehabilitation outcome, cardiac patients, exercise intensity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill group
Arm Type
Active Comparator
Arm Description
Interval exercise performed on treadmills, supervised
Arm Title
Exercise groups
Arm Type
Active Comparator
Arm Description
Supervised and organised in groups of ten
Arm Title
home-based exercise
Arm Type
Active Comparator
Arm Description
Interval training at home, free choice of modality
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Interval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week.
Primary Outcome Measure Information:
Title
VO2peak
Time Frame
baseline, after 12 weeks and after 1 year
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
baseline, 12 weeks and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: coronary artery disease age over 18 referred to cardiac rehabilitation exercise tolerance demonstrated Exclusion Criteria: severe arrhythmia heart failure drug abuse pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asbjørn Støylen, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
St.Olavs University Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25689059
Citation
Aamot IL, Karlsen T, Dalen H, Stoylen A. Long-term Exercise Adherence After High-intensity Interval Training in Cardiac Rehabilitation: A Randomized Study. Physiother Res Int. 2016 Mar;21(1):54-64. doi: 10.1002/pri.1619. Epub 2015 Feb 16.
Results Reference
result
PubMed Identifier
23613224
Citation
Aamot IL, Forbord SH, Gustad K, Lockra V, Stensen A, Berg AT, Dalen H, Karlsen T, Stoylen A. Home-based versus hospital-based high-intensity interval training in cardiac rehabilitation: a randomized study. Eur J Prev Cardiol. 2014 Sep;21(9):1070-8. doi: 10.1177/2047487313488299. Epub 2013 Apr 23.
Results Reference
result

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Aerobic Interval Training in Cardiac Rehabilitation

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