Clinical trial NCT06200948: Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema
Official title: Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema: A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lymphedema, Lower Limb
Gynecologic Cancer
Keywords: Aerobic training
Cycling ergometry
Gynecological cancer
Lymphedema
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Aerobic Training
timeFrame: baseline and at 3rd weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
state: Bilkent/Çankaya
Study officials:
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: Onur Kara, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: Gül Mete Civelek, M.D.
role: STUDY_DIRECTOR
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: Meltem Dalyan, M.D.
role: STUDY_CHAIR
affiliation: Health Sciences University, Gulhane Physiotherapy and Rehabilitation Faculty
name: Cansu Şahbaz Pirinççi, Pt. (PhD.)
role: STUDY_CHAIR
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: Rabia Tarlabölen, Pt.
role: STUDY_CHAIR
References:
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 Sci Monit. 2020 Jun 17;26:e924071. doi: 10.12659/MSM.924071.
citation: 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.