1 Centre for Sport and Exercise Science, Sheffield Hallam University, U. K. 2 York Trials Unit,...
1
1 Centre for Sport and Exercise Science, Sheffield Hallam University, U.K. 2 York Trials Unit, Department of Health Sciences, University of York, U.K. 3 Health Economics and Decision Science, ScHARR, University of Sheffield, U.K. 4 School 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 IN PATIENTS WITH VENOUS ULCERATION UNDER A NATIONAL HEALTHCARE SYSTEM – A STUDY PROTOCOL Markos Klonizakis 1 , Garry A. Tew 2 , Jonathan Michaels 3 , Helen Crank 1 , Geoff Middleton 4 , Anil Gumber 5 Background • Chronic venous insufficiency (CVI) affects 6.6-9.4% of the general population (increasing to 10-21% in adults >50 years), with 1-2% of these individuals developing venous ulceration. Treatment of venous ulcers places a huge financial burden on national healthcare services. • Compression hosiery is currently the most common treatment for venous ulcers. However, ulceration recurrence rates are high and thus alternative therapies need to be pursued. •Supervised exercise training involving a combination of aerobic and resistance exercises might be useful adjunct to compression hosiery in the prevention and treatment of venous ulcers, via favourable effects on lower-limb blood flow and vascular function. •Hence we are proposing a feasibility study for a definitive randomised controlled trial of a combined exercise and compression hosiery intervention to improve health outcomes in patients with newly-diagnosed venous ulcers. Aims Define the feasibility and characteristics of the potential outcome measures and also assess the time taken, burden and completeness of the various outcome measures in order to identify an appropriate subset of measures to use in a definitive trial. Evaluate qualitatively [e.g. direct patient experience of the intervention] and quantitatively [e.g. compliance] our supervised exercise intervention and also test patient acceptability of the exercise programme. Examine the strength of patient preferences for either the intervention or control arms [qualitative data]. Methods •This is a randomised, controlled, assessor- blinded, two-center feasibility trial with two parallel groups. •Eighty patients with new venous ulcers are randomly assigned to receive either a 12- week exercise programme combined with compression stockings or usual care (compression only). Exercising participants will undertake three sessions of supervised exercise each week (combining walking, cycling and leg-strength and flexibility exercises). •Baseline measurements will include the collection of demographic data, health- related QoL information, clinical and exercise history, ulcer size and ABPI measurements, lower-limb cutaneous microvascular function measurements and a physical fitness assessment. •Baseline measurements will be repeated at 3 and 12 months post-randomisation. A postal questionnaire follow-up will also be conducted at 6 months post-randomisation. •Outcome measures will include time to reference ulcer 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 microvascular function and physical fitness. IONTOPHORESIS NO NO EDHF cGMP ACh Figure 1:- Microvascular Assessments (Drugs and Mechanisms) Smooth Muscle Cell Endothel ium Acknowledgments This poster summarises independent research funded by the U.K. National Institute for Health Research (NIHR) under its Research for Patient Benefit Programme (Grant Reference Number PB-PG-0213-30029). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department Figure 2:- Patient Study Journey for Eligible Participants Criteria for Success The feasibility study should proceed to a larger randomised controlled trial if: a] An appropriate primary outcome variable is defined; b] At least 67% of randomised patients in the exercise group are compliant with the intervention. c] Loss to follow-up at 12 months is less than 20%; d] Patient preferences result in the conclusion that a randomised controlled trial is a feasible design. * Norm al health-care pathw ay continues ** Norm al health-care pathw ay iscom pleted w ith healing Patientshow s interestand agreesto take partin the study. Eligibility confirm ed. Baseline m easurem ents. Random isation . Patientis random ized at exercise group – 12 w eeksofexercise. Patientis random ized at norm al care group. 12 w eeksof intervention are com pleted. Baseline m easurem entsare repeated. Diaries are checked. Baseline m easurem entsare repeated at 1 yearafterstudy recruitm ent. Q oL questionnairesalso repeated at6 m onths overthe post. Diariesare checked. Study iscom pleted 1 yearafter recruitm ent. Diariesare returned to research team . Data analysisand final reportpreparation, approxim ately3 yearsafterstudy initiation. * * ** **
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Transcript of 1 Centre for Sport and Exercise Science, Sheffield Hallam University, U. K. 2 York Trials Unit,...
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 IN PATIENTS WITH VENOUS ULCERATION UNDER A
NATIONAL HEALTHCARE SYSTEM – A STUDY PROTOCOLMarkos Klonizakis1, Garry A. Tew2, Jonathan Michaels3, Helen Crank1, Geoff Middleton4, Anil Gumber5
Background
• Chronic venous insufficiency (CVI) affects 6.6-9.4% of the general population (increasing to 10-21% in adults >50 years), with 1-2% of these individuals developing venous ulceration. Treatment of venous ulcers places a huge financial burden on national healthcare services.
• Compression hosiery is currently the most common treatment for venous ulcers. However, ulceration recurrence rates are high and thus alternative therapies need to be pursued.
•Supervised exercise training involving a combination of aerobic and resistance exercises might be useful adjunct to compression hosiery in the prevention and treatment of venous ulcers, via favourable effects on lower-limb blood flow and vascular function.
•Hence we are proposing a feasibility study for a definitive randomised controlled trial of a combined exercise and compression hosiery intervention to improve health outcomes in patients with newly-diagnosed venous ulcers.
AimsDefine the feasibility and characteristics of the potential outcome measures and also assess the time taken, burden and completeness of the various outcome measures in order to identify an appropriate subset of measures to use in a definitive trial.
Evaluate qualitatively [e.g. direct patient experience of the intervention] and quantitatively [e.g. compliance] our supervised exercise intervention and also test patient acceptability of the exercise programme.
Examine the strength of patient preferences for either the intervention or control arms [qualitative data].
Methods
•This is a randomised, controlled, assessor-blinded, two-center feasibility trial with two parallel groups.
•Eighty patients with new venous ulcers are randomly assigned to receive either a 12-week exercise programme combined with compression stockings or usual care (compression only). Exercising participants will undertake three sessions of supervised exercise each week (combining walking, cycling and leg-strength and flexibility exercises).
•Baseline measurements will include the collection of demographic data, health-related QoL information, clinical and exercise history, ulcer size and ABPI measurements, lower-limb cutaneous microvascular function measurements and a physical fitness assessment.
•Baseline measurements will be repeated at 3 and 12 months post-randomisation. A postal questionnaire follow-up will also be conducted at 6 months post-randomisation.
•Outcome measures will include time to reference ulcer 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 microvascular function and physical fitness.
IONTOPHORESIS
NO
NOEDHF
cGMP
ACh
Figure 1:- Microvascular Assessments (Drugs and Mechanisms)
Smooth Muscle Cell
Endothelium
AcknowledgmentsThis poster summarises independent research funded by the U.K. National Institute for Health Research (NIHR) under its Research for Patient Benefit Programme (Grant Reference Number PB-PG-0213-30029). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
* Normal health-care pathway continues ** Normal health-care pathway is completed with healing
Patient shows interest and
agrees to take part in the
study.
Eligibility confirmed. Baseline measurements.Randomisation.
Patient is randomized at exercise group – 12 weeks of exercise.
Patient is randomized at normal care group.
12 weeks of intervention are completed. Baseline measurements are repeated. Diaries are checked.
Baseline measurements are repeated at 1 year after study recruitment. QoL questionnaires also repeated at 6 months over the post. Diaries are checked.
Study is completed 1 year after recruitment. Diaries are returned to research team. Data analysis and final report preparation, approximately 3 years after study initiation.
*
* **
**
Figure 2:- Patient Study Journey for Eligible Participants
Criteria for SuccessThe feasibility study should proceed to a larger randomised controlled trial if: a] An appropriate primary outcome variable is defined; b] At least 67% of randomised patients in the exercise group are compliant with the intervention.c] Loss to follow-up at 12 months is less than 20%;d] Patient preferences result in the conclusion that a randomised controlled trial is a feasible design.
