Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema

Ankara City Hospital

Status: Completed

Conditions: Lymphedema, Lower Limb; Gynecologic Cancer; Lymphedema

Treatments: Other: Aerobic Exercise; Other: Complete Decongestive Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06200948

10025140

Details and patient eligibility

About

Comparison of complete decongestive treatment and complete decongestive treatment + cycling ergometry treatment in patients with gynecologic cancer-related lower extremity lymphedema in terms of quality of life, lower extremity functionality and lower extremity volume measurement

Full description

After being informed about study and potential risks, all patients giving written informed consent will undergo screening period determine eligibility for study entry. The patients who met the eligibility recruitments will get into the assessment.

The study will include 63 participants (31 controls and 32 interventions). Simple randomization will be preferred in this study. The coin toss method will be used for simple randomization.

Researcher will record demographic and clinical data of the patients and will evaluate the patients' pre-treatment volumes by circumference measurement method. Researcher will evaluate quality of life by lymphedema quality of life questionnaire (LYMQOL) and lower extremity functionality by lower extremity functional scale (LEFS). While the patients in non-cycling group will get only complete decongestive treatment (CDT) for 3 weeks, the patients in cycling group will get CDT+cycling ergometry treatment for 3 weeks.Cycling ergometry treatment will be performed with Voit AT-200 Black Collection horizontal bike for 20 minutes. Exercise intensity will be adjusted to %40-59 of heart rate reserve (HRR). At the end of treatment; Researcher will evaluate volume, functionality and quality of life of the patients again and will compare the two groups in terms of volume measurement, functionality and quality of life.

Enrollment: 63 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being cognitively competent
• Chemotherapy radiotherapy etc. treatment has been completed and there is no oncological risk
• Signing written informed consent to participate in the study

Exclusion criteria

• Cardiac failure
• Uncontrolled hypertension
• Having kidney failure
• Having a systemic infection
• Local infection such as erysipelas and cellulitis in the lower extremities
• Venous insufficiency (DVT etc.)
• Presence of any neuromuscular disease affecting the lower extremities
• Having lipolymphedema
• Fracture in the lower extremity
• Having active metastasis
• Having a language problem
• Being pregnant
• Being unable to continue treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

63 participants in 2 patient groups

non-cycling group

Active Comparator group

Description:

patients will receive only complete decongestive treatment

Treatment:

Other: Complete Decongestive Treatment

cycling group

Active Comparator group

Description:

patients will receive complete decongestive treatment + cycling ergometry treatment

Treatment:

Other: Complete Decongestive Treatment

Other: Aerobic Exercise