Effectiveness and acceptableness of an exercise regime using a portable device to improve leg lymphoedema

Not Applicable

Completed

• Conditions: ymphoedema; Circulatory System; Lymphoedema

• Registration Number: ISRCTN21615265
• Lead Sponsor: Cumbria Partnership NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-29
• Study Completion: 2023-03-31
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified