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

Not Applicable

Completed

• Conditions: Gynecologic Cancer; Lymphedema, Lower Limb; Lymphedema
• Interventions: Other: Aerobic Exercise; Other: Complete Decongestive Treatment

• Registration Number: NCT06200948
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-10-15
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-29
• Study First Posted: 2024-01-11
• Status Verified: 2024-05
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cycling group	Complete Decongestive Treatment	patients will receive complete decongestive treatment + cycling ergometry treatment
non-cycling group	Complete Decongestive Treatment	patients will receive only complete decongestive treatment
cycling group	Aerobic Exercise	patients will receive complete decongestive treatment + cycling ergometry treatment

Primary Outcome Measures

Name	Time	Method
Effect of Aerobic Training	baseline and at 3rd weeks	Assesment of the effect of aerobic training on quality of life, functionality and volume difference in patients with gynecologic cancer-related lower extremity lymphedema

Trial Locations

Locations (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital; 🇹🇷 Ankara, Bilkent/Çankaya, Turkey