PEDAL trial
Research type
Research Study
Full title
Plantar Exercise, Daily, for Lymphoedema, a single-centre, controlled, prospective, randomized feasibility trial
IRAS ID
265968
Contact name
Stacey Fisher
Contact email
Sponsor organisation
North Cumbria Integrated Care NHS Foundation Trust (was Cumbria Partnership NHS FT; ODS still RNN)
ISRCTN Number
ISRCTN21615265
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Chronic lymphoedema is a long-term medical condition that results in swelling of the limbs or other body parts. The cause of fluid build-up in particularly the arms and/or legs is problems with the lymphatic system, which is a network of glands and vessels that helps fight infection and remove excess liquid in the body. Lymphoedema of the legs is common in people who: may have another chronic condition such as heart failure, COPD, or vascular disease; are inactive for long periods; are overweight or obese; or have had cancer treatment to eg the pelvis. There is some evidence to suggest that specific resistance exercise of the calf muscle – moving the front of the foot up and down by plantar flexion, similar to what a drummer does when using the foot pedal of a drum - may improve the calf muscle pump function and help reduce fluid build-up. It has been shown that at least in the short-term there is better blood flow and endurance if the calf muscle is exercised in this manner.
As yet there remains considerable uncertainty as to the effects of an exercise programme on leg lymphoedema symptom control. There is very limited research data available on the medium- to long-term effects of calf muscle exercising by lymphoedema patients on the volume of the legs. This study is a prospective, controlled, randomised, feasibility trial to determine if the use of a CE-approved plantar flexion pedal, developed by StepIt Ltd, will be of benefit to people with lymphoedema of the leg. This study initially aimed to assess the feasibility of conducting a full randomised clinical trial in the future. After analysis of results from data involving an initial 24 patients, one outcome measure will be change in leg volume at 6 and 12 weeks. Other outcome measures will include acceptability of use of the device, trial completion rates, and lymphoedema-related quality of life. Due to the swelling experienced by leg lymphoedema patients, physical activity may be hard to achieve for some patients. Initiating calf muscle exercises whilst sitting down may be a first step in increasing physical activity for this population and improving calf muscle pump function.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0413
Date of REC Opinion
12 Mar 2020
REC opinion
Further Information Favourable Opinion