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

A

Ankara City Hospital

Status

Completed

Conditions

Lymphedema, Lower Limb
Gynecologic Cancer
Lymphedema

Treatments

Other: Aerobic Exercise
Other: Complete Decongestive Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06200948
10025140

Details and patient eligibility

About

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

Full 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.

Enrollment

63 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

non-cycling group
Active Comparator group
Description:
patients will receive only complete decongestive treatment
Treatment:
Other: Complete Decongestive Treatment
cycling group
Active Comparator group
Description:
patients will receive complete decongestive treatment + cycling ergometry treatment
Treatment:
Other: Complete Decongestive Treatment
Other: Aerobic Exercise

Trial contacts and locations

1

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Central trial contact

Onur Kara, M.D.

Data sourced from clinicaltrials.gov

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