The Initial Effect of Training on Mitochondrial Function... | NCT01842412

Studies
The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication

NCT01842412

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Oct 25, 2016Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Intermittent Claudication

Interventions

exercise

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Mar 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Apr 25, 2013

First Submission Date that Met QC Criteria

Apr 26, 2013

First Posted Date

Apr 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 25, 2016Estimated

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
claudication			Behavioral: exercise
healthy			Behavioral: exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise	Behavioral	one bout of exercise training	claudication healthy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mitochondrial function	respirometry	One day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A history of any type of uni- or bilateral exertion leg pain.
A maximal claudication distance that is less than 300 meter
Diagnosed with intermittent claudication secondary to vascular insufficiency
An ankle-brachial index between 0.4 and 0.9.
Lives in Trondheim

Exclusion Criteria:

Diagnosed with critical limb ischemia
ankle-brachial index > 0.90 or < 0.4
Limited exercise tolerance
Warfarin or heparin usage
Diabetes mellitus
Underwent a vascular intervention in the last 3 months
Active cancer, renal- or liver disease.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Outpatient clinic, vascular surgery, Trondheim, Norway

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Øyvind Ellingsen, prof	Norwegisn University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for circulation and medical imaging, NTNU		Trondheim	Postboks 8905	7491	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27760222	Result	van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJ. Mitochondrial Respiration after One Session of Calf Raise Exercise in Patients with Peripheral Vascular Disease and Healthy Older Adults. PLoS One. 2016 Oct 19;11(10):e0165038. doi: 10.1371/journal.pone.0165038. eCollection 2016.

ID	Term
D007383	Intermittent Claudication
D009043	Motor Activity

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena