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The effects of bicycling exercise in people with lower limb lymphedema

The feasibility and effects of high-frequency moderate-intensity bicycling exercise in people with lower limb lymphedema: a randomized controlled pilot trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10242104
Enrollment
30
Registered
2023-02-09
Start date
2018-11-21
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower limb lymphedema Circulatory System Lymphoedema, not elsewhere classified

Interventions

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 perfo
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 every 2 weeks during

Sponsors

Lund University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 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

Exclusion criteria

Exclusion criteria: 1. Recurrence of cancer disease 2. Language limitations or dementia 3. Presence of concurrent diseases or medication affecting the limb volume or inability to perform bicycling exercise

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026