1 Centre for Sport and Exercise Science, Sheffield Hallam University, U.K.
2York Trials Unit, Department of Health Sciences, University of York, U.K.
3Health Economics and Decision Science, ScHARR, University of Sheffield, U.K.
4School of Sport and Exercise Science, University of Lincoln, U.K.
5 Centre for Health and Social Care Research, Sheffield Hallam University, U.K.
1 Centre for Sport and Exercise Science, Sheffield Hallam University, U.K.
2York Trials Unit, Department of Health Sciences, University of York, U.K.
3Health Economics and Decision Science, ScHARR, University of Sheffield, U.K.
4School of Sport and Exercise Science, University of Lincoln, U.K.
5 Centre for Health and Social Care Research, Sheffield Hallam University, U.K.
EXPLORING THE FEASIBILITY OF IMPLEMENTING AN EXERCISE INTERVENTION INPATIENTS WITH VENOUS ULCERATION UNDER A NATIONAL HEALTHCARE SYSTEM – ASTUDY PROTOCOL
, Markos Klonizakis1, Garry A. Tew2, Jonathan Michaels3, Helen Crank1, Geoff Middleton4, AnilGumber5
Background
• Chronic venous insufficiency (CVI) affects 6.6-9.4%of the general population (increasing to 10-21% inadults >50 years), with 1-2% of these individualsdeveloping venous ulceration. Treatment of venousulcers places a huge financial burden on nationalhealthcare services.
• Compression hosiery is currently the most commontreatment for venous ulcers. However, ulcerationrecurrence rates are high and thus alternativetherapies need to be pursued.
•Supervised exercise training involving a combinationof aerobic and resistance exercises might be usefuladjunct to compression hosiery in the prevention andtreatment of venous ulcers, via favourable effects onlower-limb blood flow and vascular function.
•Hence we are proposing a feasibility study for adefinitive randomised controlled trial of a combinedexercise and compression hosiery intervention toimprove health outcomes in patients with newly-diagnosed venous ulcers.
Aims
Define the feasibility and characteristics of thepotential outcome measures and also assess the timetaken, burden and completeness of the various outcomemeasures in order to identify an appropriate subsetof measures to use in a definitive trial.
Evaluate qualitatively [e.g. direct patient experienceof the intervention] and quantitatively [e.g.compliance] our supervised exercise intervention andalso test patient acceptability of the exerciseprogramme.
Examine the strength of patient preferences foreither the intervention or control arms [qualitativedata].
Methods
•This is a randomised, controlled, assessor-blinded,two-center feasibility trial with two parallelgroups.
•Eighty patients with new venous ulcers are randomlyassigned to receive either a 12-week exerciseprogramme combined with compression stockings orusual care (compression only). Exercising participantswill undertake three sessions of supervised exerciseeach week (combining walking, cycling and leg-strength and flexibility exercises).
•Baseline measurements will include the collection ofdemographic data, health-related QoL information,clinical and exercise history, ulcer size and ABPImeasurements, lower-limb cutaneous microvascularfunction measurements and a physical fitnessassessment.
•Baseline measurements will be repeated at 3 and 12months post-randomisation. A postal questionnairefollow-up will also be conducted at 6 months post-randomisation.
•Outcome measures will include time to referenceulcer healed, proportion of patients healed,percentage and absolute change in ulcer size,proportion of time patients are ulcer-free, Health-related QoL, Lower-limb cutaneous microvascularfunction and physical fitness.
IONTOPHORESIS
NO
NO
EDHF
cGMP
ACh
Figure 1:- Microvascular Assessments (Drugs andMechanisms)
Smooth Muscle Cell
Endothelium
Acknowledgments
This poster summarises independent research funded bythe U.K. National Institute for Health Research (NIHR)under its Research for Patient Benefit Programme (GrantReference Number PB-PG-0213-30029). The views expressedare those of the authors and not necessarily those ofthe NHS, the NIHR or the Department of Health.
Figure 2:- Patient Study Journey for Eligible Participants
Criteria for Success
The feasibility study should proceed to a largerrandomised controlled trial if:
a] An appropriate primary outcome variable isdefined; b] At least 67% of randomised patients inthe exercise group are compliant with theintervention.
c] Loss to follow-up at 12 months is less than 20%;
d] Patient preferences result in the conclusion thata randomised controlled trial is a feasible design.
