Lymphoedema Circulatory System Lymphoedema
Conditions
Interventions
Participants will be randomised to either the control group (standard care) or the intervention group (standard care plus use of a StepIt pedal) for 12 weeks. Those in the intervention group will be i
Sponsors
Cumbria Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over the age of 18 2. Diagnosis of chronic leg lymphoedema (chronicity > 3 months). This includes primary or secondary lymphoedema 3. Lymhpoedema can be present in one leg or both legs 4. Newly presenting to lymphoedema service or existing patients 5. Same type of compression therapy for at least two months 6. Presence of leg ulcer is not an exclusion criterion 7. Command of English, verbal and in writing 8. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity 2. Currently receiving, or within six months of receiving, chemotherapy or radiotherapy for cancer 3. Surgery on lower limb within last three months 4. Surgery within last month 5. BMI > 40 6. Active infection in one or both of the legs treated with systematic antibiotics (or within one week of finishing antibiotics) 7. Inability to comply with the StepIt pedal exercise, e.g. due to fixed ankle or other pathology that impedes using the StepIt pedal. This will be established during the screening/consent process by trialling the StepIt pedal and the movement involved in clinic 8. Commenced, or change in dosage of, diuretic medication in last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participants’ experience of and compliance to StepIt exercise regime measured using a bespoke questionnaire at 12 weeks Assessed at the end of the study: 2. Recruitment and attrition rates, willingness of patients to be randomised, response rates to questionnaires, and degrees of missing data 3. Testing of eligibility criteria and ability/willingness of clinical staff to partake in recruitment of participants 4. Ability of site and clinicians to recruit and randomise patients, irrespective of care setting 5. To assess any training requirements 6. Adequacy of duration of follow-up (e.g. in relation to lymphoedema management and outcomes) 7. Fitness for purpose of data collection methods including across and between care settings 8. Number of and character of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcome measures 1. Leg volume (measured using Kunhke’s technique), at week 0, 6, 12 1.1. Measured only between 9.30am to 3.30pm 1.2. Where possible the same rater is used for each participant; name of rater will be recorded. 2. Ankle circumference measurement, using lateral malleolus as reference point at week 0, 6, 12 3. Clinician’s oedema severity score at week 0, 6, 12 4. Ankle range of motion in degrees measured using goniometer at week 0, 6, 12 5. Pain score is measured using the visual analogue score (VAS) at week 0, 6, 12 6. Quality of life is measured using two tools -- EQ-5D-5L and LYMQOL-L Questionnaire -- at week 0, 6, 12 7. Participant opinion on trial participation, at week 12 (StepIt users only) measured using a bespoke questionnaire Assessed at the end of the study: 8. Patient withdrawal rates due to change in management (e.g. need for surgery, hospital admission, infection, or other) calculated at the end of the study recruitment window 9. Leg infection rates, primarily cellulitis, calculated using a survey of patient notes at the end of the study | — |
Countries
England, United Kingdom
Outcome results
None listed