Caffeine and Intermittent Claudication
Primary Purpose
Intermittent Claudication
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Caffeine 6mg/kg
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring Intermittent Claudication, PAD, Caffeine, Walking capacity, ABI, QoL, Growth factor
Eligibility Criteria
Inclusion Criteria:
- men and women > 40 years
- history of IC of the lower extremities, Fontaine II
- ankle-brachial index (ABI)> 0.9 (subjects who are referred for a revasularizarition procedure)
Exclusion Criteria:
- dementia
- diabetes
- illness or reason to be unable to participate, f.ex. general weakness, amputation or arthritis
- acute illness, f.ex. inflammation, unstable angina
- other reasons which contraindicate participation/treadmill exercise
- intake of Trental and/or Teofyllamin
- weight > 100kg
Sites / Locations
- Herning Hospital, Surgical research dep.
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Quality of life
Maximum walking distance
Secondary Outcome Measures
Painfree Walking Distance
Max muscle strength (MVC) of kneeextension
Endurance of 50%MVC kneeextension
Postural stability
Reaction speed
Cognitive function
Walking Impairment Questionnaire
vascular endothelian growth factors VGF. FGF
Full Information
NCT ID
NCT00388128
First Posted
October 12, 2006
Last Updated
June 8, 2011
Sponsor
University of Aarhus
Collaborators
Herning Hospital, Central Jutland Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00388128
Brief Title
Caffeine and Intermittent Claudication
Official Title
Effects of Caffeine in Patients With Intermittent Claudication.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Herning Hospital, Central Jutland Regional Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the change in Walking capacity after an intake of caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Half of all will be revascularised, follow up will be after 3 months. It is hypothesized that caffeine (6mg/kg) can be a cheap, safe drug before walking exercise. Primary endpoint is maximum walking distance (MWD), treadmill-testing,(constant load, 0%,2m/h). Secondary endpoints are pain free walking distance (PWD), maximum muscle strength, endurance, reaction speed, balance, cognitive function, health related quality of life (SF-36).
Detailed Description
PAD has a prevalence of 15-20 % in an elderly (>50) western population. PAD can not be seen in isolation but represents the peripheral manifestation of a generalized artherosclerosis. The co-morbidity with coronary or cerebralartherosclerosis depends on the degree of severity of PAD, the relative risk of a death (predominantly cardiac) is increased by a factor 4. From af medical and a socio-economic point of view there is the need to control the PAD complication rate and related treatment costs as effectively as possible.
The aim of any treatment of intermittent claudication is a clinically relevant improvement in the patient´s mobility and quality of life.
There is agreement, that physical training does improve the collateralisation of vascular lesions, the rheologic properties of blood and lead to a shift from glycolytic to oxidative muscle fibers in the working musculature which increases the capillary density. The effect of physical training is also to modify the patients risk factor profile, even moderate training increase the insulin receptor sensitivity and the fibrinolytic activity and decrease the dLDL/HDL ratio and the diastolic blood pressure in hypertensive patients - and thereby decrease the overall cardiac mortality.
This is a Phase 3, 12-week, double-blind, randomized, placebo-controlled cross-over and a follow-up study with 80 patients with intermittent claudication, half of which will be revascularized.
The objectives of this study are to evaluate the efficacy of caffeine (6mg/kg)and the revascularisation procedure. The primary end-point will be maximal walking distance (MWD) in both groups of patients. Other efficacy measures will include claudication onset time (PWD), changes in Ankle Brachial Index (ABI), Quality of Life (QoL), cognitive function, plasma response of Vascular Endothelian Growth Factor (VEGF, FGF). Safety variables will include routine hematology parameters and adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Intermittent Claudication, PAD, Caffeine, Walking capacity, ABI, QoL, Growth factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Caffeine 6mg/kg
Intervention Description
Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
during test 1 and 3
Title
Maximum walking distance
Time Frame
during treadmill test
Secondary Outcome Measure Information:
Title
Painfree Walking Distance
Time Frame
treadmill test
Title
Max muscle strength (MVC) of kneeextension
Time Frame
At end of each test
Title
Endurance of 50%MVC kneeextension
Time Frame
At end of each test
Title
Postural stability
Time Frame
in all tests
Title
Reaction speed
Time Frame
in all tests
Title
Cognitive function
Time Frame
in all tests
Title
Walking Impairment Questionnaire
Time Frame
in first and third test
Title
vascular endothelian growth factors VGF. FGF
Time Frame
before and after 1. and 2. test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
men and women > 40 years
history of IC of the lower extremities, Fontaine II
ankle-brachial index (ABI)> 0.9 (subjects who are referred for a revasularizarition procedure)
Exclusion Criteria:
dementia
diabetes
illness or reason to be unable to participate, f.ex. general weakness, amputation or arthritis
acute illness, f.ex. inflammation, unstable angina
other reasons which contraindicate participation/treadmill exercise
intake of Trental and/or Teofyllamin
weight > 100kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Mette H Momsen, MPH, Phys, ph.D stud
Organizational Affiliation
Herning Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herning Hospital, Surgical research dep.
City
Herning
State/Province
Region Central-Jutland
ZIP/Postal Code
7400
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20629111
Citation
Momsen AH, Jensen MB, Norager CB, Madsen MR, Vestersgaard-Andersen T, Lindholt JS. Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication. Br J Surg. 2010 Oct;97(10):1503-10. doi: 10.1002/bjs.7149.
Results Reference
derived
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Caffeine and Intermittent Claudication
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