Plain English Summary
Background and study aims
Chronic venous insufficiency (CVI) is a medical condition where the veins cannot pump enough blood back to the heart, and usually affects the legs. Some patients develop leg ulcers, which can cause pain, social isolation, inability to move, and reduced quality of life. Treatment of venous ulcers places a huge financial burden on the National Health Service. Compression stockings are often used to treat venous ulcers. While they work very well, ulcers frequently come back. Some patients can also benefit from venous surgery, but ulcers frequently come back and many patients are reluctant to undergo surgery. Different therapies are therefore needed. Supervised exercise training might be useful in addition to compression therapy in the prevention and treatment of venous ulcers. Exercise is a low-cost, low-risk, and effective strategy for improving physical and mental health. However, little is currently known about the practicality and usefulness of supervised exercise training used in combination with compression in patients with venous ulcers. We have designed a study to find out the possible benefits of supervised exercise training and compression stockings in patients with venous ulceration, to see if a larger study would be possible.
Who can participate?
Eighty patients with new venous ulcers can take part in this study.
What does the study involve?
Patients will be randomly assigned to either receive usual care (i.e., wear compression stockings), or to take part in a 12-week exercise programme and wear compression stockings. Exercising participants will undertake three sessions of supervised exercise each week (a combination of walking, cycling and leg strength and flexibility exercises). Patients will be followed-up until 1 year after completing the study.
What are the possible benefits and risks of participating?
Possible benefits to be explored include improved healing rate and time, reduced complications and higher quality of life. This is a low risk study, as all participants will be screened before the exercise programme and the programme includes a fully-supervised, moderate-intensity exercise.
Where is the study run from?
The study is run from Sheffield Hallam University in association with the Sheffield Health and Social Care NHS Foundation Trust (UK). Additional recruitment is undertaken by University of Lincoln in association with Lincolnshire Community Health Services NHS Trust (UK).
When is the study starting and how long is it expected to run for?
May 2014 to May 2017.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Markos Klonizakis
m.klonizakis@shu.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Emma McIntosh
ORCID ID
Contact details
The Centre for Sport and Exercise Science
Faculty of Health and Wellbeing
City Campus
Howard Street
Sheffield
S1 1WB
United Kingdom
-
E.mcintosh@shu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16665
Study information
Scientific title
Exploring the Feasibility of Implementing a Supervised Exercise Training and Compression Hosiery Intervention in Patients with Venous Ulceration
Acronym
FISCU
Study hypothesis
Is a randomised controlled trial comparing supervised exercise training and compression therapy versus compression therapy only feasible in patients with venous ulceration?
Ethics approval
NRES Committee Yorkshire & The Humber; ref. 14/YH/0091
Study design
Randomised; Interventional; Design type: Screening
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases
Intervention
Patients are randomised to two groups:
1. Usual care : Compression stockings
2. Excercise programme: Low-to-medium term intensity exercise. Thirty six sessions over a period of 3 months.; Follow Up Length: 12 month(s); Study Entry : Registration and One or More Randomisations
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The main outcomes of the study are the ones that are going to define if this feasibility study should proceed to a larger randomised controlled trial. These will be:
1. The definition of an appropriate primary outcome variable
2. Compliance of participation of patients randomized to the exercise group
3. Loss to follow-up
4. Patience preferences in regards to the randomization group
These will be defined at the trial end (12 months).
Secondary outcome measures
1. Time to reference ulcer healed (clinical report - time of healing)
2. Proportion of patients healed (clinical report - assessed at 3, 6 and 12 months post-randomisation)
3. Percentage and absolute change in ulcer size (clinical measurement - measured at baseline, 3, 6 and 12 months post-randomisation)
4. Proportion of time patients are ulcer free (clinical report)
5. Recurrence data will be collected at 3, 6 and 12 months post-randomisation)
6. Health-related quality of life (assessed at baseline, 3, 6 and 12 months post-randomisation using the EQ-5D-5L and VEINES-QOL)
7. Lower-limb cutaneous microvascular function
8. Microvascular assessments using Laser Doppler Fluximetry and Iontophoresis at baseline, 3 months, 12 months post-randomisation
9. Physical fitness Senior Fitness Test (physical assessment, at baseline, 3 months and 12 months post-randomisation)
Overall trial start date
19/05/2014
Overall trial end date
18/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient has at least one new venous leg ulcer with a maximum diameter =1 cm
2. Patient has an ankle brachial pressure index (ABPI) =0.8 (taken within last 3 months)
3. Patient is able and willing to tolerate high compression
4. Patient is aged =18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 80; UK Sample Size: 80
Participant exclusion criteria
1. Patient is unsuitable or unable to exercise (nurse/doctor judgement)
2. Patients who are not tolerant of high-level lower-limb compression delivered by compression stockings or multilevel bandaging
3. Patients with insulin-controlled diabetes mellitus
4. Pregnant women
5. Patients with coexisting skin conditions, vasculitis, deep venous occlusion or malignant/atypical ulceration
6. Patients who require major surgery
7. Patients with leg ulcers with a maximum diameter of <1 cm
8. Patients who have had an ulcer at the same site within the previous 3 months (updated 30/07/2015: was previously 6 months)
9. Patients are unable or do not wish to consent to participation in the trial
Recruitment start date
21/07/2014
Recruitment end date
21/05/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Hallam University
Sheffield
S1 1WB
United Kingdom
Trial participating centre
University of Lincoln
Lincoln
LN6 7TS
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Publications will be protocol (under submission), physiological data (microcirculation) and overall study outcomes.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26445318