NCT01474408

Brief Summary

The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

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

November 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

November 4, 2011

Last Update Submit

February 13, 2017

Conditions

Myocardial Infarction

Keywords

Coronary artery bypassExercise therapyRevascularization (PCI)

Outcome Measures

Primary Outcomes (1)

  • Venous Compliance change

    Measured by echocardiography

    48 hours

Study Arms (3)

interval training

EXPERIMENTAL

4 x 4 minutes exercise at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate

Behavioral: interval training day 1Behavioral: Moderate exercise day 2Behavioral: Control day 3

moderate exercise

ACTIVE COMPARATOR

moderate continuous exercise at 70 % of peak heart rate on venous function.

Behavioral: interval training day 1Behavioral: Moderate exercise day 2Behavioral: Control day 3

control

OTHER

routine measurements, no exercise

Behavioral: interval training day 1Behavioral: Moderate exercise day 2Behavioral: Control day 3

Interventions

interval training day 1BEHAVIORAL
Also known as: aerobic interval training
controlinterval trainingmoderate exercise
Moderate exercise day 2BEHAVIORAL
controlinterval trainingmoderate exercise
Control day 3BEHAVIORAL
controlinterval trainingmoderate exercise

Eligibility Criteria

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

You may qualify if:

  • myocardial infraction (MI)
  • revascularization (PCI)
  • coronary artery bypass graft surgery (CABG)

You may not qualify if:

  • unstable angina pectoris
  • uncontrolled hypertension
  • orthopedic and/or neurological limitations
  • participation in other studies
  • MI (closer than 4 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutt for Sirkulasjon og Bildetechnikk, NTNU

Trondheim, Norway

Location

Related Publications (1)

  • Leinan IM, Aamot IL, Stoylen A, Karlsen T, Wisloff U. Upper arm venous compliance and fitness in stable coronary artery disease patients and healthy controls. Clin Physiol Funct Imaging. 2017 Sep;37(5):498-506. doi: 10.1111/cpf.12324. Epub 2015 Dec 15.

    PMID: 26667796RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ulrik Wisløff, prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 18, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

NO(1)