Lymphedema of LegNCT05666947
Effectiveness of Two Exercises in Preventing Lower-Limb Lymphedema After Gynecological Cancer Surgery
A study testing Home-based exercise in people with Lymphedema of Leg and Gynecologic Cancer, run by Yu-Yun Hsu.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Lymphedema of Leg, Gynecologic Cancer, Exercise
- What is being tested?
- Home-based exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women who planned to undergo gynecological cancer surgery with lymphadenectomy
- at least 20 years old
Who cannot join
- heart failure
- renal failure
- cardiovascular accident
- abscess or infection in legs
- psychological disorders
About this study
Official title: Effectiveness of Two Exercises in Preventing Lower-Limb Lymphedema After Gynecological Cancer Surgery: a Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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).
- Conditions
- Lymphedema of Leg, Gynecologic Cancer, Exercise
- Being tested
- Home-based exercise
- Keywords
- Elastic-band, Gynecological cancer, Lymphedema, Quality of life, Resistance exercise, Self-management
- Medical subject headings
- Motor Activity, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exerciseOther
Eight weeks of home-based exercise programs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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
The Lymph Self-management Scale, developed by the authors, was used to measure the participants' self-management of lymphedema in the past two weeks. The self-reported questionnaire contained 20 questions including self-examination for limb edema, wearing comfortable shoes, eating protein-rich foods, avoiding spicy or caffeinated foods, keeping regular exercise, avoiding long-time standing or sitting (> 1 hour), skin protect, and weight control. Each question was scored from 1 (never) to 5 (always). Scores range from 20 to 100, a higher score indicating better lymph self-management.
Measured: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
Exercise adherence
A dialog about exercise frequency weekly and total exercise time weekly was designed to measure the exercise adherence of the participants.
Measured: at T1 (10-11 weeks after surgery and within 1 week after intervention completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study startJan 2017
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Yun Hsu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu-Yun Hsu, National Cheng Kung University
- Investigators
- Yu-Yun Hsu, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666947
- Sponsor's protocol ID
- B-ER-105-444
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40821966
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Exercises in Preventing Lower-Limb Lymphedema After Gynecological Cancer Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05666947
- Acronym / sponsor ID
- B-ER-105-444
- Conditions
- Lymphedema of Leg, Gynecologic Cancer, Exercise
- Keywords
- Elastic-band, Gynecological cancer, Lymphedema, Quality of life, Resistance exercise, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yu-Yun HsuUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based resistance exercise | Experimental | Other: Home-based exerciseThe 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. |
| Non-resistance exercise | Placebo comparator | Other: Home-based exerciseThe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women who planned to undergo gynecological cancer surgery with lymphadenectomy
- at least 20 years old
Key exclusion criteria (5 listed)
- heart failure
- renal failure
- cardiovascular accident
- abscess or infection in legs
- psychological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exerciseEight weeks of home-based exercise programs | Other | Home-based resistance exercise, Non-resistance exercise |
Primary outcome
lymphoedema-related quality of life
Time frame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
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.
cancer quality of life
Time frame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
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).
limb circumference measurement
Time frame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
The bilateral circumferences of lower extremities were measured to assess the lymphedema status.
2 secondary outcomes
Lymph self-management
Time frame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).
Exercise adherence
Time frame: at T1 (10-11 weeks after surgery and within 1 week after intervention completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 40821966Hsu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Yun Hsu principal investigator
National Cheng Kung University
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise in people with Lymphedema of Leg and Gynecologic Cancer, run by Yu-Yun Hsu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lymphoedema-related quality of life (time frame: Three-time points, (1) baseline(T0), (2) change from baseline at 2 months(T1), (3) change from baseline at 5 months(T2).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05666947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.