NCT02249260

Brief Summary

Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation. Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac rehabilitation program.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

4.4 years

First QC Date

August 26, 2014

Last Update Submit

September 22, 2014

Conditions

Keywords

Exercise, cardiac rehabilitation, quality of life

Outcome Measures

Primary Outcomes (1)

  • Change in peak oxygen uptake

    Change from baseline in peak oxygen uptake at 15 months

    baseline, 15 months

Secondary Outcomes (4)

  • Health related quality of life

    baseline, 12 weeks

  • Peak oxygen uptake

    baseline, 12 weeks

  • Time to exhaustion

    baseline, 15 months

  • Time to exhaustion

    baseline, 12 weeks

Other Outcomes (1)

  • Systolic and diastolic Blood Pressure

    baseline, 12 weeks

Study Arms (1)

Behavioral

EXPERIMENTAL

Group-based high intensity interval training and lifestyle counseling

Behavioral: High intensity interval training

Interventions

Group-based high-intensity aerobic interval training and lifestyle counseling

Also known as: The Norwegian Ullevaal model
Behavioral

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable coronary heart disease
  • valvular surgery
  • refered to high-intensity exercise training from a cardiologist

You may not qualify if:

  • acute myocardial infarction within four week
  • serious rhythm disturbances
  • unstable angina pectoris
  • known significant comorbidity
  • symptomatic peripheral vascular disease
  • obstructive pulmonary disease with forced expiratory vital capacity \< 60% of predicted
  • left ventricular ejection fraction \< 40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Sport Clinic (NIMI)

Oslo, Oslo County, 0805, Norway

RECRUITING

MeSH Terms

Conditions

Heart DiseasesMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Birgitta B Nilsson, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc

Study Record Dates

First Submitted

August 26, 2014

First Posted

September 25, 2014

Study Start

March 1, 2011

Primary Completion

August 1, 2015

Study Completion

December 1, 2020

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations