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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06200948
Enrollment
63
Registered
2024-01-11
Start date
2023-10-15
Completion date
2024-05-23
Last updated
2024-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Cancer, Lymphedema, Lymphedema, Lower Limb

Keywords

Aerobic training, Cycling ergometry, Gynecological cancer, Lymphedema

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.

Interventions

OTHERAerobic 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).

OTHERComplete 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).

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of Aerobic Trainingbaseline and at 3rd weeksAssesment of the effect of aerobic training on quality of life, functionality and volume difference in patients with gynecologic cancer-related lower extremity lymphedema

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026