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

Gynecologic Cancer Clinical Trial

Official title:

Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema: A Randomized Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06200948
• Other study ID #: 10025140
• Status: Completed
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: May 23, 2024

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 23, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Lymphedema

Intervention

Other:
• Aerobic Exercise
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).
• Complete Decongestive Treatment
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).

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital	Ankara	Bilkent/Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Dionne A, Goulet S, Leone M, Comtois AS. Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study. J Altern Complement Med. 2018 Sep/Oct;24(9-10):1007-1009. doi: 10.1089/acm.2018.0041. — View Citation

Kendrova L, Mikulakova W, Urbanova K, Andrascikova S, Zultakova S, Takac P, Peresta Y. Comprehensive Decongestive Therapy as a Treatment for Secondary Lymphedema of the Lower Extremity and Quality of Life of Women After Gynecological Cancer Surgery. Med S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Aerobic Training	Assesment of the effect of aerobic training on quality of life, functionality and volume difference in patients with gynecologic cancer-related lower extremity lymphedema	baseline and at 3rd weeks

External Links

•   Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study
•   Comprehensive Decongestive Therapy as a Treatment for Secondary Lymphedema of the Lower Extremity and Quality of Life of Women After Gynecological Cancer Surgery