A Clinical Trial on the Effects of Home-based Five Plus Exercise Training

NCT ID: NCT02310256

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Five Plus

Exercise training

Group Type ACTIVE_COMPARATOR

Five plus exercise training

Intervention Type OTHER

calf raise exercise

Interventions

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Five plus exercise training

calf raise exercise

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Øivind Rognmo, phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Department for circulation and medical imaging, NTNU

Trondheim, Postboks 8905, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 28285932 (View on PubMed)

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.

Reference Type RESULT
PMID: 28592294 (View on PubMed)

Other Identifiers

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2011/2533/REK midt

Identifier Type: -

Identifier Source: org_study_id

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