Completed
The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication
What is being collected
Behavioral Data
+ behavioral Data
Collected from today forward - ProspectiveBehavioralNo DNA Sample
Who is being recruted
Behavior+6
+ Cardiovascular Diseases
+ Signs and Symptoms
From 50 to 80 Years
+12 Eligibility Criteria
How is the trial designed
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Observational
Study Start: April 2013
Summary
Principal SponsorNorwegian University of Science and Technology
Last updated: October 25, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication.
Principal SponsorNorwegian University of Science and Technology
Last updated: October 25, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 50 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesPeripheral Vascular DiseasesPeripheral Arterial DiseaseIntermittent ClaudicationMotor Activity
Criteria
5 inclusion criteria required to participate
A history of any type of uni- or bilateral exertion leg pain
A maximal claudication distance that is less than 300 meter
An ankle-brachial index between 0.4 and 0.9
Diagnosed with intermittent claudication secondary to vascular insufficiency
Show More Criteria
7 exclusion criteria prevent from participating
Active cancer, renal- or liver disease
Diabetes mellitus
Diagnosed with critical limb ischemia
Limited exercise tolerance
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department for circulation and medical imaging, NTNU
Trondheim, NorwayOpen Department for circulation and medical imaging, NTNU in Google MapsCompletedOne Study Center