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

NCT06200948 | Completed

• 1 other identifier: 10025140
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphedema; Lymphedema, Lower Limb; Gynecologic Cancer

Keywords

Aerobic training; Cycling ergometry; Gynecological cancer; Lymphedema

Outcome Measures

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

  baseline and at 3rd weeks

Study Arms (2)

non-cycling group

ACTIVE COMPARATOR

patients will receive only complete decongestive treatment

Other: Complete Decongestive Treatment

cycling group

ACTIVE COMPARATOR

patients will receive complete decongestive treatment + cycling ergometry treatment

Other: Aerobic Exercise; Other: Complete Decongestive Treatment

Interventions

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).

cycling group

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).

cycling group; non-cycling group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

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

Location

Related Publications (3)

• 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.

  PMID: 32555125 RESULT

• 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.

  PMID: 30247973 RESULT

• Kara O, Mete Civelek G, Sahbaz Pirincci C, Tarlabolen R, Dalyan M. Effects of aerobic cycling training in patients with gynaecologic cancer-related lower extremity lymphedema: A randomised comparative study. Support Care Cancer. 2025 Mar 19;33(4):302. doi: 10.1007/s00520-025-09354-4.

  PMID: 40108020 DERIVED

Related Links

• Comprehensive Decongestive Therapy as a Treatment for Secondary Lymphedema of the Lower Extremity and Quality of Life of Women After Gynecological Cancer Surgery
• Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study

MeSH Terms

Conditions

Lymphedema

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Onur Kara, M.D.

  Health Sciences University, Ankara Bilkent City Hospital

  PRINCIPAL INVESTIGATOR

• Gül Mete Civelek, M.D.

  Health Sciences University, Ankara Bilkent City Hospital

  STUDY DIRECTOR

• Meltem Dalyan, M.D.

  Health Sciences University, Ankara Bilkent City Hospital

  STUDY CHAIR

• Cansu Şahbaz Pirinççi, Pt. (PhD.)

  Health Sciences University, Gulhane Physiotherapy and Rehabilitation Faculty

  STUDY CHAIR

• Rabia Tarlabölen, Pt.

  Health Sciences University, Ankara Bilkent City Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 11, 2024
• Study Start: October 15, 2023
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)