LymphedemaNCT06200948
Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema
A study testing Aerobic Exercise and Complete Decongestive Treatment in people with Lymphedema and Lymphedema, Lower Limb, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lymphedema, Lymphedema, Lower Limb, Gynecologic Cancer
- What is being tested?
- Aerobic Exercise and Complete Decongestive Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 23 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Bilkent/Çankaya, 06800
About this study
Official title: Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema: A Randomized Comparative Study
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
Read the 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.
- Conditions
- Lymphedema, Lymphedema, Lower Limb, Gynecologic Cancer
- Being tested
- Aerobic Exercise, Complete Decongestive Treatment
- Keywords
- Aerobic training, Cycling ergometry, Gynecological cancer, Lymphedema
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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 TreatmentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| non-cycling group | Active comparator | patients will receive only complete decongestive treatment Receives: Other: Complete Decongestive Treatment |
| cycling group | Active comparator | patients will receive complete decongestive treatment + cycling ergometry treatment Receives: Other: Aerobic Exercise; Other: Complete Decongestive Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and at 3rd weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Oct 2023
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Kara, Ankara City Hospital Bilkent
- Investigators
- Onur Kara, M.D., Principal investigator, Health Sciences University, Ankara Bilkent City HospitalGül Mete Civelek, M.D., Study director, Health Sciences University, Ankara Bilkent City HospitalMeltem Dalyan, M.D., Study chair, Health Sciences University, Ankara Bilkent City HospitalCansu Şahbaz Pirinççi, Pt. (PhD.), Study chair, Health Sciences University, Gulhane Physiotherapy and Rehabilitation FacultyRabia Tarlabölen, Pt., Study chair, Health Sciences University, Ankara Bilkent City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200948
- Sponsor's protocol ID
- 10025140
- Status last verified
- May 2024
- First submitted
- 8 Dec 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32555125Dionne 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.
PubMed 30247973Kara 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.
PubMed 40108020
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06200948
- Acronym / sponsor ID
- 10025140
- Conditions
- Lymphedema, Lymphedema, Lower Limb, Gynecologic Cancer
- Keywords
- Aerobic training, Cycling ergometry, Gynecological cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| non-cycling group | Active comparator | Other: Complete Decongestive Treatmentpatients will receive only complete decongestive treatment |
| cycling group | Active comparator | Other: Aerobic Exercise, Other: Complete Decongestive Treatmentpatients will receive complete decongestive treatment + cycling ergometry treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Cardiac failure
- Uncontrolled hypertension
- Having kidney failure
- Having a systemic infection
- Local infection such as erysipelas and cellulitis in the lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseWhile 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). | Other | cycling group |
| Complete Decongestive TreatmentWhile 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). | Other | cycling group, non-cycling group |
Primary outcome
Effect of Aerobic Training
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Results publication: PubMed 32555125Kendrova 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.
- Results publication: PubMed 30247973Dionne 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.
- Derived from this study: PubMed 40108020Kara 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.
- Comprehensive Decongestive Therapy as a Treatment for Secondary Lymphedema of the Lower Extremity and Quality of Life of Women After Gynecological Cancer SurgeryLink provided by the sponsor.
- Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur Kara, M.D. principal investigator
Health Sciences University, Ankara Bilkent City Hospital
Gül Mete Civelek, M.D. study director
Health Sciences University, Ankara Bilkent City Hospital
Meltem Dalyan, M.D. study chair
Health Sciences University, Ankara Bilkent City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Complete Decongestive Treatment in people with Lymphedema and Lymphedema, Lower Limb, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Aerobic Training (time frame: baseline and at 3rd weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200948, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.