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Completed

NCT Number: NCT06200948

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

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

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Key information

Conditions

Lymphedema Gynecologic Cancer Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema, Lower Limb

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Bilkent/Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

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

Other

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).

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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