The effects of bicycling exercise in people with lower limb lymphedema

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: A total of 30 persons with stable lower limb lymphedema, will be randomized to either an exercise group or a control group with an allocation ratio of 2:1. The random allocation sequence will be performed using a computer software program. The exercise group will perform high‐frequency moderate bicycling on their own, on a private bicycle either indoors or outdoors, or on an indoor bike provided by the research team or at a gym (if the participant has access to a gym). The exercise should be performed 3 to 5 times a week for 8 weeks with a mean intensity of 40‐59% of the Heart Rate Reserve (HRR). Each session should last 30 to 60 minutes, corresponding to a perceived exertion rate of 12‐14 on the Borg´s Rating of Perceived Exertion (RPE) Scale. A Polar heart rate monitor will be provided by us and used during all exercise sessions to monitor the heart rate. Before each exercise session there will be some warming‐up exercises consisting of bicycling at a self‐chosen speed for 5 minutes. After each session there will be a cool‐down period consisting of bicycling at a self‐chosen pace and stretching. At baseline, the participants in the exercise group will receive written information and verbal instructions about the exercise sessions, the Polar heart rate monitor, Borg´s RPE scale, the warming up, cooling down and stretching. A logbook will be used to register; i) the date for each exercise session; ii) the subjective sensation of heaviness and tightness in the lower limbs rated on a Visual Analog Scale, prior to each exercise session and after; iii) the total time for the exercise session in minutes; iv) average heart rate during the exercise session; v) any adverse events related to the performance of the exercise. The logbook will be checked by CJ ever CONDITION: Lower limb lymphedema ; Circulatory System ; Lymphoedema, not elsewhere classified PRIMARY OUTCOME: ; 1. Lower limb volume, measured as circumferential measurements every 4th cm along the limb at baseline and after 8 weeks. The formula of a truncated cone is used to calculate the total limb volume; 2. Local tissue water, measured at 14 different points on the calf and thigh by the MoistureMeterD at baseline and after 8 weeks; 3. Arm‐to‐leg impedance, calculated by measurements of the impedance to extracellular fluid by bioimpedance spectroscopy (BIS) at baseline and after 8 weeks; SECONDARY OUTCOME: ; 1. Cardiovascular fitness measured by a submaximal ergometer test at baseline and after 8 weeks; 2. Health‐related quality of life measured by the questionnaire Lymphedema Quality of Life Inventory (LyQLI) at baseline and after 8 weeks; 3. Impairments, activity limitations and participation restrictions related to the lower limb lymphedema, measured by the questionnaire Lymph‐ICF‐LL at baseline and after 8 weeks; 4. Perception of heaviness and tightness in the lymphedema limb/ limbs measured by the Visual Analogue Scale (VAS) at baseline and after 8 weeks; 5. Leisure time physical activity during the last 6 months measured by the Saltin‐Grimby Physical Activity Level Scale at baseline; INCLUSION CRITERIA: 1. 18 years or older 2. Uni‐or bilateral, primary or secondary lower limb lymphedema 3. Persistent lymphedema for at least 6 months 4. A volume variation of less than 5% for each limb during the last 6 months
Epistemonikos ID: 255ed3f88341609d10211a0d3959275bb8908b36
First added on: Feb 20, 2024