Clinical trial NCT05666947: Effectiveness of Two Exercises in Preventing Lower-Limb Lymphedema After Gynecological Cancer Surgery
Official title: Effectiveness of Two Exercises in Preventing Lower-Limb Lymphedema After Gynecological Cancer Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Leg
Gynecologic Cancer
Exercise
Keywords: Elastic-band
Gynecological cancer
Lymphedema
Quality of life
Resistance exercise
Self-management
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 1. Participants and setting Participants were recruited from a gynecological ward of a medical center in southern Taiwan. The following criteria were used to determine who was eligible to participate in this study: (1) women who planned to undergo gynecological cancer surgery with lymphadenectomy, and (2) at least 20 years old. Exclusion criteria for the participants were: (1) heart failure; (2) renal failure; (3) cardiovascular accident; (4) abscess or infection in legs; or (5) psychological disorders.
2. Sample size G-power software version 3.1.9 was applied to estimate the sample size. The sample size was determined based on a previous study. Given an α-level of 0.05, an effect size of 0.37, a power of 0.80, and considering a 15% possibility of participants' dropping out, the minimum required sample size was estimated as 30 participants in each group.
3. Randomization and Blinding Eligible participants were randomly assigned into either an experimental group or a control group using a randomized block design with a ratio of 2:2. A research staff who was not involved in data collection generated in advance the random allocation sequence with 15 blocks. Each block contributed to the allocation of 2 participants in the experimental group (anti-resistance exercise) and 2 participants in the intervention group. Sequential numbers which assigned to two groups were generated and placed in sealed opaque envelopes.
4. Data analysis Data were managed and analyzed using SPSS. Descriptive statistics were applied to summarize the characteristics of the participants and study outcomes. Chi-square tests (or Fisher's exact test) and Mann-Whitney U-test were applied for the group comparisons in demographic data and outcome variables and at baseline. The Generalized Estimating Equations (GEE) were used to assess for any differential changes in the outcome variables by testing the time effect, group effect, and group\*time effect with p \< 0.05 as a level of significance.
5. Ethical considerations Before data collection, the hospital's Institutional Review Board of the primary investigator reviewed and approved this study (IRB No. B-ER-105-444).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: lymphoedema-related quality of life
timeFrame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
measure: cancer quality of life
timeFrame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
measure: limb circumference measurement
timeFrame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
Secondary outcomes:
measure: Lymph self-management
timeFrame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
measure: Exercise adherence
timeFrame: at T1 (10-11 weeks after surgery and within 1 week after intervention completion)
Other outcomes:
Locations:
Study officials:
affiliation: National Cheng Kung University
name: Yu-Yun Hsu
role: PRINCIPAL_INVESTIGATOR
References: