NCT02310256

Brief Summary

The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

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, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

November 10, 2014

Last Update Submit

March 28, 2018

Conditions

Intermittent Claudication

Keywords

Mitochondria, muscleExerciseBlood Flow Velocity

Outcome Measures

Primary Outcomes (2)

  • absolute walking distance (meters) as measured by 6 minute walking test

    treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test

    8 weeks

  • mitochondrial function measured by respirometry

    Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry

    8 weeks

Secondary Outcomes (3)

  • Arterial bloodflow measured by plethysmography

    8 weeks

  • Quality of life assessed by SF 36 and CLAU-S questionnaires

    8 weeks

  • Peak oxygen uptake measured by cardio-pulmonal exercise testing

    8 weeks

Study Arms (2)

Usual care

NO INTERVENTION

Five Plus

ACTIVE COMPARATOR

Exercise training

Other: Five plus exercise training

Interventions

Five plus exercise trainingOTHER

calf raise exercise

Five Plus

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with intermittent claudication secondary to vascular insufficiency
  • An ankle-brachial index between 0.4 and 0.9.

You may not qualify if:

  • Diagnosed with critical limb ischemia
  • Ankle-brachial index (ABI) \> 0.90 or \< 0.4
  • Limited exercise tolerance
  • Warfarin or heparin usage
  • Underwent a vascular intervention in the last 6 months
  • Active cancer, renal- or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for circulation and medical imaging, NTNU

Trondheim, Postboks 8905, 7491, Norway

Location

Related Publications (2)

  • Van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson E. Calf raise exercise increases walking performance in patients with intermittent claudication. J Vasc Surg. 2017 May;65(5):1473-1482. doi: 10.1016/j.jvs.2016.12.106. Epub 2017 Mar 9.

    PMID: 28285932RESULT

  • van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJR. Exercise in claudicants increase or decrease walking ability and the response relates to mitochondrial function. J Transl Med. 2017 Jun 7;15(1):130. doi: 10.1186/s12967-017-1232-6.

    PMID: 28592294RESULT

MeSH Terms

Conditions

Intermittent ClaudicationMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Øivind Rognmo, phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2014

First Posted

December 8, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

NO(1)