Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200948
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2023-12-08
Brief Title:
Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema A Randomized Comparative Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CDTcycling ergometry treatment for 3 weeksCycling 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
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 CDTcycling ergometry treatment for 3 weeksCycling 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None