Feasibility of an Exercise Intervention in Patients with Venous Ulcers

ISRCTN	ISRCTN10205425
DOI	https://doi.org/10.1186/ISRCTN10205425
Secondary identifying numbers	16665

Submission date: 08/05/2014
Registration date: 08/05/2014
Last edited: 26/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Miss Emma McIntosh
Scientific

The Centre for Sport and Exercise Science
Faculty of Health and Wellbeing
City Campus, Howard Street
Sheffield
S1 1WB
United Kingdom

Email	E.mcintosh@shu.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Screening
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Exploring the Feasibility of Implementing a Supervised Exercise Training and Compression Hosiery Intervention in Patients with Venous Ulceration
Study acronym	FISCU
Study objectives	Is a randomised controlled trial comparing supervised exercise training and compression therapy versus compression therapy only feasible in patients with venous ulceration?
Ethics approval(s)	NRES Committee Yorkshire & The Humber; ref. 14/YH/0091
Health condition(s) or problem(s) studied	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
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 study start date	19/05/2014
Completion date	18/05/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 80; UK Sample Size: 80
Key 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
Key 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
Date of first enrolment	21/07/2014
Date of final enrolment	21/05/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Sheffield Hallam University

Sheffield
S1 1WB
United Kingdom

University of Lincoln

Lincoln
LN6 7TS
United Kingdom

Sponsor information

Sheffield Health and Social Care NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Yiwei Harland
Fulwood House, Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
England
United Kingdom

"ROR"	https://ror.org/05cn4v910

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Publications will be protocol (under submission), physiological data (microcirculation) and overall study outcomes.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/10/2015		Yes	No
Results article	results	01/05/2018		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

26/11/2018: Publication reference added.