Condition category
Circulatory System
Date applied
28/10/2019
Date assigned
30/10/2019
Last edited
30/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Venous leg ulcers (VLUs) affect almost 400,000 people over the age of 65 in the UK. These are triggered by inadequate blood flow through the veins, causing pain, mobility restrictions, devastation and social isolation. Each VLU costs about £2k/year to the NHS, while annual healthcare costs are about £400 million. Compression therapy (most commonly stockings or bandages) are used to treat VLUs: although healing rates are good, ulcers often return. Moreover, many remain open for up to 1 year, needing about 50 visits to heal. Consequently, supportive therapies to compression are needed to reduce healing times. Exercise may provide an answer. The researchers recently examined if it was possible to use a 12-week, community-based exercise programme, along with compression therapy, to treat VLUs. The programme was safe, participants enjoyed it and were attending their sessions. The programme also offered reduced healing times and savings to the NHS of up £875/ulcer. Nevertheless, the programme wasn’t accessible by people who are house-bound and could otherwise do the programme exercises. Therefore, the researchers need to design and explore the practicality of a home-based exercise programme, which would be offered to patients who cannot travel. This is worth trying, as findings indicate that 74% of house-bound people with VLUs would willingly try such a programme.

Who can participate?
Patients aged 18 and over with at least one VLU

What does the study involve?
In Phase 1, patients help design the home-based exercise programme. In Phase 2, patients are randomly allocated to one of the two study groups to receive home-based exercise and standard care, or standard care only, for 12 weeks with an extra 3 weeks to allow for missed sessions. Patients are assessed at 3 and 6 months to explore any changes that might take place in the lower leg physiology and quality of life. Finally, in Phase 3 the researchers talk to Phase 2 participants to hear about their study experience and refine the programme further.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Sheffield Hallam University (UK)

When is the study starting and how long is it expected to run for?
December 2018 to September 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Dr Markos Klonizakis
m.klonizakis@shu.ac.uk
2. Emma McIntosh
E.mcintosh@shu.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Markos Klonizakis

ORCID ID

http://orcid.org/0000-0002-8864-4403

Contact details

Department of Nursing and Midwifery
Faculty of Health and Wellbeing
Sheffield Hallam University
Sheffield
S10 2NA
United Kingdom
+44 (0)114 225 5697
m.klonizakis@shu.ac.uk

Type

Scientific

Additional contact

Ms Emma McIntosh

ORCID ID

Contact details

Sheffield Hallam University
A203
Collegiate Hall
Collegiate Crescent
Sheffield
S10 2BP
United Kingdom
-
E.mcintosh@shu.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 42699

Study information

Scientific title

Development and feasibility-testing of a home-based exercise training and compression hosiery intervention for people with venous ulceration

Acronym

FISCU II

Study hypothesis

Venous leg ulcers (VLUs) affect almost 400,000 people over the age of 65 in the U.K. These are triggered by inadequate blood flow through the veins, causing pain, mobility restrictions, devastation and social isolation. Each VLU costs about £2k/year to the NHS, while annual healthcare costs are about £400 million. Compression therapy (most commonly stockings or bandages) are used to treat VLUs: although healing rates are good, ulcers often return. Moreover, many remain open for up to 1 year, needing about 50 visits to heal. Consequently, supportive therapies to compression are needed to reduce healing times. Exercise may provide an answer. The researchers recently examined if it was possible to use a 12-week, community-based exercise programme, along with compression therapy, to treat VLUs. The programme was safe, participants enjoyed it and were attending their sessions. The programme also offered reduced healing times and savings to the NHS of up £875/ulcer. Nevertheless, the programme wasn’t accessible by people who are house-bound and could otherwise do the programme exercises. Therefore, the researchers need to design and explore the practicality of a home-based exercise programme, which would be offered to patients who cannot travel. This is worth trying, as findings indicate that 74% of house-bound people with VLUs would willingly try such a programme. In Phase 1, people with VLUs will help to design the home-based exercise programme. In Phase 2, the researchers will recruit people with VLUs in Sheffield, who although house-bound, can do some exercises (flexibility, stretching and chair-aerobics) and are mentally healthy. The researchers will have the intervention tested and explore any changes that might take place in the lower leg physiology and quality of life. Finally, in Phase 3 the researchers will talk to Phase 2 participants to hear about their study experience and refine the programme further.

The main research question for this study is: Can we develop and pilot test a home-based, exercise intervention for home-bound people with VLUs?
Phase 1: The primary aim of Phase 1 will be to develop, with the support of people with VLUs in specially-arranged focus groups and interviews, a home-based, exercise intervention, modelled on the exercises delivered on the successful FISCU community-based exercise programme. Specific objectives will include: a) the definition of the regularity/mode/type of support offered by the intervention facilitators to participants, b) the choice of exercises implemented in the home-based programme (based on exercises that are appropriate to meet the programme's targets), c) the adaptation of materials and resources provided to participants and d) the retention/adherence promotion strategy/monitoring followed during home-based delivery
Phase 2: The primary aims for Phase 2 are to estimate the rates of compliance and retention for a definitive trial. Specific objectives include: i) to assess the ease of data collection required for each potential primary outcome (including participant burden and impact of participant’s cognition, assessed via qualitative data). ii) to evaluate quantitatively (i.e. compliance) the proposed exercise intervention
Phase 3: The primary aims for Phase 3 will be to conduct post-intervention interviews with participants and using the obtained information to refine the design and delivery of the home-based programme. The specific objective for Phase 3 will be to evaluate qualitatively (i.e. direct patient experience of the interventions) and then carry out the intervention refinement task

Ethics approval

Approved 24/04/2019, London Surrey Research Ethics Committee (Tel: +44 (0)20 7104 8222; Email:
NRESCommittee.SECoast-Surrey@nhs.net), ref: 18/LO/1983

Study design

Randomised; Both; Design type: Treatment, Process of Care, Complex Intervention, Physical, Rehabilitation, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Venous leg ulcers

Intervention

Following baseline measurements, participants (n=40) will be randomised remotely to one of the two study groups (Group A: home-based exercise and standard care, n=20; Group B: standard care only, n=20) by the study statistician (to ensure allocation concealment), using a computer programme (nQuery Advisor 6.0, Statistical Solutions, Ireland) to generate stratified block randomisation with variable block-size. Stratification will be on the basis of ulcer size (e.g., ulcer size greater than 3 cm or between 1 and 3 cm in any direction).

Total duration of treatment: 12 weeks with an extra 3 weeks to allow for missed sessions
Follow-up for both groups: assessment at 3 months and 6 months after baseline

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Recruitment rates measured as rate of invited participants who are eligible and consenting and reported in Consolidated Standards of Reporting Trials (CONSORT) flowchart
2. Acceptability of procedures assessed by examining reasons for drop-out in discontinuing participants and comparing attrition between groups
3. Suitability of measurement procedures evaluated by completion rates and reasons for missing data
4. Attrition rates established as discontinuation of intervention and loss to follow-up measurement
5. The acceptability of the exercise programme assessed by using session compliance data and participant feedback via one-to-one, semi-structured interviews conducted after the 3-month follow-up visit
6. Exercise safety assessed by exploring reasons for drop-out from the intervention and the number and type of adverse events that occur in each group
7. Group contamination assessed by the number of people in the control group who take up exercise as a result of their study participation

Secondary outcome measures

1. Health-related quality of life assessed using EQ-5D-5L and VEINES-QOL at baseline and at 3 and 6 months
2. Physical fitness assessed using Senior Fitness Test at baseline and at 3 and 6 months

Overall trial start date

03/12/2018

Overall trial end date

01/09/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Are at least 18 years of age
2. Have at least one venous leg ulcer of primarily venous aetiology (determined by a clinician) with a maximum diameter ≥ 1 cm
3. Have an ankle brachial pressure index (ABPI) ≥ 0.8 (recorded within the previous 3 months)
4. Are able/willing to tolerate lower-limb compression

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 58; UK Sample Size: 58

Participant exclusion criteria

1. Are unsuitable/unable to exercise (determined by a clinician at screening or baseline)
2. Are unable/unwilling to tolerate lower-limb compression
3. Have insulin-controlled diabetes mellitus
4. Are pregnant
5. Have coexisting skin conditions, vasculitis, deep venous occlusion or malignant/atypical ulceration (if suitable otherwise, participants may be re-considered at a later stage)
6. Require major surgery within 3 months from eligibility assessment
7. Have a leg ulcer with a maximum diameter ≤1 cm
8. Have had an ulcer at the same site within the previous 3 months
9. Are unable or do not wish to consent to participation in the trial

Recruitment start date

01/09/2019

Recruitment end date

01/02/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Sports and Exercise Science (CSES)
Sheffield Hallam University Collegiate Campus Collegiate Crescent
Sheffield
S10 2BP
United Kingdom

Sponsor information

Organisation

Sheffield Health & Social Care NHS Foundation Trust

Sponsor details

c/o Dr Michelle Horspool
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom
+44 (0)114 226 3338
Michelle.Horspool@shsc.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-0418-20021

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers aim to publish their research in a high impact peer-reviewed journal. No addition files will be available for upload.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to these being used for consecutive grant applications following the end of the current one and lack of relevant ethical approval.

Intention to publish date

01/02/2024

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/10/2019: Trial's existence confirmed by the NIHR.