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CompletedNCT06200948Updated May 24, 2024

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

An interventional study of Aerobic Exercise and Complete Decongestive Treatment in Lymphedema, Lymphedema, Lower Limb and Gynecologic Cancer, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-24.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Lymphedema
  • Lymphedema, Lower Limb
  • Gynecologic Cancer

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Keywords

  • Aerobic training
  • Cycling ergometry
  • Gynecological cancer
  • Lymphedema
03

In context

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's enrollment of 63 is above the median of 50 across 403 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Active comparator
    non-cycling group

    patients will receive only complete decongestive treatment

    Other: Complete Decongestive Treatment

  • Active comparator
    cycling group

    patients will receive complete decongestive treatment + cycling ergometry treatment

    Other: Aerobic Exercise · Other: Complete Decongestive Treatment

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).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline and at 3rd weeks

07

Study locations

1 site
  • Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
    Ankara, Bilkent/Çankaya 06800, Turkey
08

References and documents

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 32555125 ↗
  • Dionne 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 30247973 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06200948
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Onur Kara (Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor), Ankara City Hospital Bilkent) — Principal investigator
First posted
Jan 11, 2024
Start date
Oct 15, 2023
Primary completion
May 23, 2024
Completion
May 23, 2024
Last update
May 24, 2024

Study contacts

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
Cansu Şahbaz Pirinççi, Pt. (PhD.)
study chair · Health Sciences University, Gulhane Physiotherapy and Rehabilitation Faculty
Rabia Tarlabölen, Pt.
study chair · Health Sciences University, Ankara Bilkent City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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