Effectiveness of Two Exercises in Preventing Lower-Limb Lymphedema After Gynecological Cancer Surgery

NCT05666947 | Completed DMC

• 1 other identifier: B-ER-105-444
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Lower-limb lymphedema is one of the complications after gynecological cancer surgery. Patients with lymphedema are more likely to limit their daily life activities and become inactive, leading to negative influences on quality of life. Although studies on resistance exercise primarily focus on the upper limb, there scarce evidence of the application of this exercise to the lower limb has been reported. Objective: This study will aim to compare the effect of resistance and non-resistance exercises in the prevention of lower-limb lymphedema, increasing self-management, and improving the quality of life of the patients following gynecological cancer surgery. Design: A single-blinded randomized controlled trial. Settings and participants: Sixty patients with gynecological cancer will recruit from a gynecological ward and will be randomly assigned to the elastic-band resistance exercise group (experimental group, n = 30) or conventional non-resistance exercise group (control group, n = 30). Methods: Both groups will receive one-to-one training about upper and lower limb exercises within 1 week after surgery. Each exercise will consist of a 5-minute warm-up session, a 20-minute main session, and a relaxing session. Patients in the experimental group will use an elastic band and change the elastic band from low to medium resistance. Patients in the experimental and control groups will receive guidelines from a booklet and video about elastic-band resistance and conventional non-resistance exercise, respectively. All patients will be evaluated at three-time points: T0-within 1 week after surgery and before the intervention, T1-10-11 weeks after surgery and within 1 week after intervention, T2-3 months after intervention using Lymph-ICF-LL scale, EORTC QLQ-C30 questionnaire, limb circumference measurements, and lymph self-management questionnaire. The Chi-square test, Fisher's exact test, the Mann-Whitney U-test, and the Generalized Estimating Equations will be used for the statistical analysis of the data. Anticipated Outcomes: Findings from this study could provide a reference for home-based resistance exercise guidelines and be integrated into the care of activities for women following gynecological surgery with lower-limb lymphoedema.

Conditions

Lymphedema of Leg; Gynecologic Cancer; Exercise

Keywords

Elastic-band; Gynecological cancer; Lymphedema; Quality of life; Resistance exercise; Self-management

Outcome Measures

Primary Outcomes (3)

• lymphoedema-related quality of life

  Chinese version of the Lymph-ICF-LL(Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema) was used to evaluate the quality of life related to lower-limb lymphedema. This scale includes 28 questions over five domains: physical function (6 questions), mental function (6 questions), general tasks/household (3 questions), mobility (7 questions), and life/ social life (6 questions). The participants were required to rate their answers on an 11-point scale (from 0 = no problem to 10 = very serious). The total score and scores on each domain of the Lymph-ICF-LL were computed as follows: (sum of scores on questions/ total number of answered questions) x 10. Thus, the scores ranged from 0 to 100 with a higher score indicating lower quality of life related to lower limb lymphedema.

  Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).

• cancer quality of life

  The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3 was used to measure the quality of life related to cancer. The questionnaire contained 30 questions, including five functional items (physical, role, emotional, cognitive, and social functioning), nine symptom items, and the single item of global health status. Except for the global health status, each question was rated from 1 (not at all) to 4 (very much). In addition, the global health status was rated from 1 (very poor) to 7 (excellent).

  Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).

• limb circumference measurement

  The bilateral circumferences of lower extremities were measured to assess the lymphedema status.

  Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).

Secondary Outcomes (2)

• Lymph self-management

  Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).

• Exercise adherence

  at T1 (10-11 weeks after surgery and within 1 week after intervention completion)

Study Arms (2)

Home-based resistance exercise

EXPERIMENTAL

The experimental group participated in a home-based exercise program for eight weeks, namely elastic-band resistance exercise. Participants were forwarded to the next exercise session every two weeks and completed the exercise program within eight weeks. The program included upper and lower limb exercises. The home-based exercise program contained four sessions, namely: warm-up, start-up, vigorous, and reinforcement sessions. Participants received guidelines from a booklet and video about elastic-band resistance.

Other: Home-based exercise

Non-resistance exercise

PLACEBO COMPARATOR

The control group participated in an exercise program for eight weeks, namely conventional non-resistance exercise, which contained four sessions: warm-up, start-up, vigorous, and reinforcement. Participants were forwarded to the next exercise session every two weeks and completed the exercise program within eight weeks. Participants in the control group received guidelines from a booklet and video about the conventional non-resistance exercise.

Other: Home-based exercise

Interventions

Home-based exercise OTHER

Eight weeks of home-based exercise programs

Home-based resistance exercise; Non-resistance exercise

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women who planned to undergo gynecological cancer surgery with lymphadenectomy
• at least 20 years old

You may not qualify if:

• heart failure
• renal failure
• cardiovascular accident
• abscess or infection in legs
• psychological disorders

Sponsors & Collaborators

• Yu-Yun Hsu: lead

Related Publications (1)

• Hsu YY, Lin CF, Liang PC, Nguyen TTB, Hsu KF. Effects of resistance exercise on reducing the risk of lower-limb lymphedema after gynecological cancer surgery. Asia Pac J Oncol Nurs. 2025 Jul 14;12:100756. doi: 10.1016/j.apjon.2025.100756. eCollection 2025 Dec.

  PMID: 40821966 DERIVED

MeSH Terms

Conditions

Motor Activity; Lymphedema

Condition Hierarchy (Ancestors)

Behavior; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Yu-Yun Hsu

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 28, 2022
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 20, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share