NCT00388128

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2006

Typical duration for phase_3

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

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 9, 2011

Status Verified

June 1, 2011

Enrollment Period

2.7 years

First QC Date

October 12, 2006

Last Update Submit

June 8, 2011

Conditions

Intermittent Claudication

Keywords

Intermittent ClaudicationPADCaffeineWalking capacityABIQoLGrowth factor

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    during test 1 and 3

  • Maximum walking distance

    during treadmill test

Secondary Outcomes (8)

  • Painfree Walking Distance

    treadmill test

  • Max muscle strength (MVC) of kneeextension

    At end of each test

  • Endurance of 50%MVC kneeextension

    At end of each test

  • Postural stability

    in all tests

  • Reaction speed

    in all tests

  • +3 more secondary outcomes

Study Arms (1)

A

PLACEBO COMPARATOR
Drug: Caffeine 6mg/kg

Interventions

Caffeine 6mg/kgDRUG

Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing

A

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herning Hospital, Surgical research dep.

Herning, Central Jutland, 7400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 20629111DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Caffeine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Anne-Mette H Momsen, MPH, Phys, ph.D stud

    Herning Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

September 1, 2006

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

June 9, 2011

Record last verified: 2011-06

Locations

DK(1)