Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema
NCT ID: NCT06200948
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2023-10-15
2024-05-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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non-cycling group
patients will receive only complete decongestive treatment
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).
cycling group
patients will receive complete decongestive treatment + cycling ergometry treatment
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Chemotherapy radiotherapy etc. treatment has been completed and there is no oncological risk
* Signing written informed consent to participate in the study
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Onur Kara
Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)
Principal Investigators
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Onur Kara, M.D.
Role: PRINCIPAL_INVESTIGATOR
Health Sciences University, Ankara Bilkent City Hospital
Gül Mete Civelek, M.D.
Role: STUDY_DIRECTOR
Health Sciences University, Ankara Bilkent City Hospital
Meltem Dalyan, M.D.
Role: STUDY_CHAIR
Health Sciences University, Ankara Bilkent City Hospital
Cansu Şahbaz Pirinççi, Pt. (PhD.)
Role: STUDY_CHAIR
Health Sciences University, Gulhane Physiotherapy and Rehabilitation Faculty
Rabia Tarlabölen, Pt.
Role: STUDY_CHAIR
Health Sciences University, Ankara Bilkent City Hospital
Locations
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Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Bilkent/Çankaya, Turkey (Türkiye)
Countries
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References
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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.
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.
Kara O, Mete Civelek G, Sahbaz Pirincci C, Tarlabolen R, Dalyan M. Effects of aerobic cycling training in patients with gynaecologic cancer-related lower extremity lymphedema: A randomised comparative study. Support Care Cancer. 2025 Mar 19;33(4):302. doi: 10.1007/s00520-025-09354-4.
Related Links
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Comprehensive Decongestive Therapy as a Treatment for Secondary Lymphedema of the Lower Extremity and Quality of Life of Women After Gynecological Cancer Surgery
Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study
Other Identifiers
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10025140
Identifier Type: -
Identifier Source: org_study_id
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