Back to resultsA Clinical Trial on the Effects of Home-based Five Plus Exercise Training
Primary Purpose
Intermittent Claudication
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Five plus exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring Mitochondria, muscle, Exercise, Blood Flow Velocity
Eligibility Criteria
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
Sites / Locations
- Department for circulation and medical imaging, NTNU
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual care
Five Plus
Arm Description
Exercise training
Outcomes
Primary Outcome Measures
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
mitochondrial function measured by respirometry
Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry
Secondary Outcome Measures
Arterial bloodflow measured by plethysmography
measured by plethysmography
Quality of life assessed by SF 36 and CLAU-S questionnaires
assessed by SF 36 and CLAU-S questionnaires
Peak oxygen uptake measured by cardio-pulmonal exercise testing
measured by cardio-pulmonal exercise testing
Full Information
NCT ID
NCT02310256
First Posted
November 10, 2014
Last Updated
March 28, 2018
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02310256
Brief Title
A Clinical Trial on the Effects of Home-based Five Plus Exercise Training
Official Title
A Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Mitochondria, muscle, Exercise, Blood Flow Velocity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Five Plus
Arm Type
Active Comparator
Arm Description
Exercise training
Intervention Type
Other
Intervention Name(s)
Five plus exercise training
Intervention Description
calf raise exercise
Primary Outcome Measure Information:
Title
absolute walking distance (meters) as measured by 6 minute walking test
Description
treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test
Time Frame
8 weeks
Title
mitochondrial function measured by respirometry
Description
Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Arterial bloodflow measured by plethysmography
Description
measured by plethysmography
Time Frame
8 weeks
Title
Quality of life assessed by SF 36 and CLAU-S questionnaires
Description
assessed by SF 36 and CLAU-S questionnaires
Time Frame
8 weeks
Title
Peak oxygen uptake measured by cardio-pulmonal exercise testing
Description
measured by cardio-pulmonal exercise testing
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øivind Rognmo, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department for circulation and medical imaging, NTNU
City
Trondheim
State/Province
Postboks 8905
ZIP/Postal Code
7491
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
28285932
Citation
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.
Results Reference
result
PubMed Identifier
28592294
Citation
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.
Results Reference
result
Learn more about this trial
A Clinical Trial on the Effects of Home-based Five Plus Exercise Training
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