Interdialytic Weight GainMLDNCT06156371
The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue
A study testing lymphatic drainage massage and classic massage in people with Interdialytic Weight Gain and Fatigue, run by Mersin University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of lymphatic drainage massage on interdialytic weight gain and fatigue in patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interdialytic Weight Gain, Fatigue
- What is being tested?
- lymphatic drainage massage and classic massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 Nov 2023to 23 Nov 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hemodialysis at Private Ata Dialysis Center, Private Diamer Dialysis Center, Mersin Nephrology Private Dialysis Center and Private Mersin Dialysis Center between 30.11.2023-30.06.2024 coming for treatment,
- Receiving hemodialysis treatment 3 times a week for at least 6 months,
- The average interdialytic weight gain in the last 3 sessions exceeds 4% of the dry weight,
- Volunteer to participate in the research and
- Individuals who can speak and understand Turkish will be included in the research.
Who cannot join
- Using insulin,
- Diagnosed with malignant tumor,
- Having deep vein thrombosis and heart failure diagnosed by a physician,
- Those with missing limbs or infected, open wounds in the application areas,
- Pregnant and
- Individuals who are in another complementary treatment program will not be included in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Turkey, Mersin University
Mersin
Mersin Nephrology Private Dialysis Center, Private Ata Dialysis Center, Private Diamer Dialysis Center and Private Mersin Dialysis Center'
Yenişehir
About this study
Official title: The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue in Patients Undergoing Hemodialysis
The aim of this study is to evaluate the effect of lymphatic drainage massage on interdialytic weight gain and fatigue in patients undergoing hemodialysis.
Read the detailed description
Since there is no similar study in the literature, a preliminary application was made to determine the sample size. According to the inclusion criteria, after reaching a total of 36 people, namely Intervention I = 12, Intervention II = 12 and control group = 12, a power analysis was performed, and the minimum sample size to be taken with 5% type 1 error and 80% power was determined as 60 people. Considering that there might be a 25% loss in the sample, it was decided to include 25 people in the Intervention I group, 25 in the Intervention II group and 25 in the control group, making a total of 75 people, namely Intervention I = 25, Intervention II = 25, Control = 25.36 people. A patient in Intervention 1 (n=25) group will receive a lymphatic drainage massage for 20 minutes a day, 3 days a week, a total of 12 times for 4 weeks. The application will start 1 hour after the patient enters hemodialysis. Before the application, the patient will be placed in a supine position and the researcher will ensure that the feet are elevated to 45 degrees for the application to be effective. In practice, after the infraclavicular lymph node, which is located at the point where the veins in the neck area meet the thymus gland and called the "main terminal" lymph node, is stimulated with a pumping action, lymphatic drainage will be applied to the upper legs, lower legs and feet. A patient in Intervention 2 (n=25) group will receive classical massage on the upper legs, lower legs and feet for 15 minutes a day, 3 days a week, a total of 12 times for 4 weeks. The application will start 1 hour after the patient enters hemodialysis. No intervention other than the first and last evaluation will be applied to the control group. At the end of the study, participants will be given full information, stating that they were not informed about the specific purpose of the study for scientific reasons. The effect of lymphatic drainage massage on interdialysis weight gain and fatigue are the primary outcomes of the study. The effect of lymphatic drainage massage on blood pressure and laboratory findings are secondary outcomes of the study. The results will be collected before and after intervention in the 1st, 2nd, 3rd and 4th weeks.
- Conditions
- Interdialytic Weight Gain, Fatigue
- Being tested
- lymphatic drainage massage, classic massage
- Keywords
- Interdialytic weight gain, Fatigue, Lymphatic drainage, Massage, Hemodialysis
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphatic drainage massageOther
Before the application, the patient will be placed in a supine position and the feet will be elevated to 45 degrees by the researcher. After the infraclavicular lymph node, located at the point where the veins in the neck area meet the thymus gland, is stimulated with a pumping action, lower extremity applications will be started in the form of upper legs, lower legs and feet; By stimulating the inguinal lymph node in the upper leg application, the popliteal lymph node in the lower leg application, and the medial malleolus lymph node in the foot application, the mobility of the lymph fluid in the direction of the stimulated lymph node is used using "stroking, pumping, circular movements or rolling movements" according to the weight characteristic, body type and preference of the patient. will be provided. Finally, passive exercise will be performed 5 times, repeating both legs in flexion and extension positions, and the infraclavicular lymph node will be stimulated.
classic massageOther
The application will be done by the researcher. The order of application is upper leg, lower leg and feet. During the application, appropriate methods such as effleurage (stroking), kneading, friction, impact and vibration will be used. The application will start with efflorescence and end with the same technique. To the upper leg; Starting from the knee to the groin, to the lower leg; The application will be made in the direction of the muscle fibers, starting from the ankle to the knee. Appropriate techniques will be used depending on the characteristics of the application areas, and each technique will be repeated 5-10 times. In the final stage, passive exercise will be performed by moving to the foot and applying flexion and extension to the ankle 5 times. The application will be completed by applying similar applications to the upper and lower legs on the back of the foot and the outer and lower surface of the foot. Olive oil will be used as essential oil during application.
| Study group | Role | What they receive |
|---|---|---|
| Lymphatic drainage massage | Experimental | In the lymphatic drainage massage group, a patient will receive a total of 12 treatments, 20 minutes a day, 3 days a week for 4 weeks. Face-to-face manual lymphatic drainage massage will be performed at least 1 hour after the patient starts hemodialysis treatment, according to the morning and afternoon work schedules of the institutions. Manual lymphatic drainage massage will be performed by a certified researcher in accordance with the application steps. Receives: Other: lymphatic drainage massage |
| Classic massage | Active comparator | A patient in the classical massage group will receive a total of 12 treatments, 15 minutes a day, 3 days a week for 4 weeks. The classical face-to-face massage application will be performed at least 1 hour after the patient starts hemodialysis treatment, according to the morning and afternoon work schedules of the institutions.
Classical massage application will be performed by the researcher. The order of application is upper leg, lower leg and feet. During the application, appropriate methods such as effleurage (stroking), kneading, friction, impact and vibration, which are frequently used in classical massage, will be used. Olive oil will be used as essential oil during application. Receives: Other: classic massage |
| Control | No intervention | No intervention other than the first and last evaluation will be applied to the control group. Patients in this group will continue to receive their usual hemodialysis treatment and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interdialytic weight gain
In hemodialysis centers, patients' weights are measured and recorded with an electronic scale by the healthcare personnel working in the institution before and after each hemodialysis session. Measurements are made by removing the patients' jackets/coats and shoes. The measurements will be recorded in kilograms by the researcher and weekly interdialytic weight gain will be evaluated.
Measured: Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application
Fatigue evaluated using the Fatigue Severity Scale
The Turkish validity and reliability of the scale, which was developed by Krupp et al. in 1989, was tested by Armutlu et al. in 2007, and the Cronbach's alpha coefficient was found to be 0.89, and the test-retest reliability was 0.81 (p = 0.719, within 99% confidence interval). The scale, which evaluates individuals' fatigue status in the last month, consists of a total of 9 items and each item is scored between 1-7. "Strongly disagree = 1", "moderately disagree = 2", "somewhat disagree = 3", "neither agree nor disagree = 4", "somewhat agree = 5", "moderately agree = 6", "strongly agree = It is evaluated as 7" points. The total score calculation of the scale is calculated by adding up the scores given to each item to 9.
It is done by dividing. The lowest score that can be obtained from the scale is 1 and the highest score is 7. A total score of 4 or more from the scale indicates severe fatigue. A higher score indicates increased fatigue.
Measured: Change before the application and 4th week of the application
Secondary outcomes (2)
Blood pressure measurement
Blood pressure measurements of the patients will be taken before and after the application. A calibrated blood pressure monitor provided by the researcher will be used for all patients during measurements. Blood pressure measurements will be made and recorded at the dialysis center by healthcare personnel who are not involved in the research. The average systolic and diastolic blood pressure values of the patients will be calculated and evaluated weekly.
Measured: Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application
Evaluation of biochemical findings
With permission from the institutions and patients, previously performed laboratory tests will be evaluated and recorded retrospectively. From laboratory findings, albumin, urea, creatinine, sodium, potassium, calcium, phosphorus and urea clearance will be evaluated.
Measured: Change before the application and 4th week of the application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start11 Nov 2023
- Primary completion11 Dec 2023
- Study completion23 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdialytic Weight GainStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi ÖNEN EFECAN, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156371
- Sponsor's protocol ID
- Eonenefecan001
- Acronym
- MLD
- Status last verified
- Jan 2024
- First submitted
- 26 Nov 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue in Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT06156371
- Acronym / sponsor ID
- MLD / Eonenefecan001
- Conditions
- Interdialytic Weight Gain, Fatigue
- Keywords
- Interdialytic weight gain, Fatigue, Lymphatic drainage, Massage, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 5 Dec 2023 (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.
The aim of this study is to evaluate the effect of lymphatic drainage massage on interdialytic weight gain and fatigue in patients undergoing hemodialysis.
Detailed description
Since there is no similar study in the literature, a preliminary application was made to determine the sample size. According to the inclusion criteria, after reaching a total of 36 people, namely Intervention I = 12, Intervention II = 12 and control group = 12, a power analysis was performed, and the minimum sample size to be taken with 5% type 1 error and 80% power was determined as 60 people. Considering that there might be a 25% loss in the sample, it was decided to include 25 people in the Intervention I group, 25 in the Intervention II group and 25 in the control group, making a total of 75 people, namely Intervention I = 25, Intervention II = 25, Control = 25.36 people. A patient in Intervention 1 (n=25) group will receive a lymphatic drainage massage for 20 minutes a day, 3 days a week, a total of 12 times for 4 weeks. The application will start 1 hour after the patient enters hemodialysis. Before the application, the patient will be placed in a supine position and the researcher will ensure that the feet are elevated to 45 degrees for the application to be effective. In practice, after the infraclavicular lymph node, which is located at the point where the veins in the neck area meet the thymus gland and called the "main terminal" lymph node, is stimulated with a pumping action, lymphatic drainage will be applied to the upper legs, lower legs and feet. A patient in Intervention 2 (n=25) group will receive classical massage on the upper legs, lower legs and feet for 15 minutes a day, 3 days a week, a total of 12 times for 4 weeks. The application will start 1 hour after the patient enters hemodialysis. No intervention other than the first and last evaluation will be applied to the control group. At the end of the study, participants will be given full information, stating that they were not informed about the specific purpose of the study for scientific reasons. The effect of lymphatic drainage massage on interdialysis weight gain and fatigue are the primary outcomes of the study. The effect of lymphatic drainage massage on blood pressure and laboratory findings are secondary outcomes of the study. The results will be collected before and after intervention in the 1st, 2nd, 3rd and 4th weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- prospective, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lymphatic drainage massage | Experimental | Other: lymphatic drainage massageIn the lymphatic drainage massage group, a patient will receive a total of 12 treatments, 20 minutes a day, 3 days a week for 4 weeks. Face-to-face manual lymphatic drainage massage will be performed at least 1 hour after the patient starts hemodialysis treatment, according to the morning and afternoon work schedules of the institutions. Manual lymphatic drainage massage will be performed by a certified researcher in accordance with the application steps. |
| Classic massage | Active comparator | Other: classic massageA patient in the classical massage group will receive a total of 12 treatments, 15 minutes a day, 3 days a week for 4 weeks. The classical face-to-face massage application will be performed at least 1 hour after the patient starts hemodialysis treatment, according to the morning and afternoon work schedules of the institutions. Classical massage application will be performed by the researcher. The order of application is upper leg, lower leg and feet. During the application, appropriate methods such as effleurage (stroking), kneading, friction, impact and vibration, which are frequently used in classical massage, will be used. Olive oil will be used as essential oil during application. |
| Control | No intervention | –No intervention other than the first and last evaluation will be applied to the control group. Patients in this group will continue to receive their usual hemodialysis treatment and care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemodialysis at Private Ata Dialysis Center, Private Diamer Dialysis Center, Mersin Nephrology Private Dialysis Center and Private Mersin Dialysis Center between 30.11.2023-30.06.2024 coming for treatment,
- Receiving hemodialysis treatment 3 times a week for at least 6 months,
- The average interdialytic weight gain in the last 3 sessions exceeds 4% of the dry weight,
- Volunteer to participate in the research and
- Individuals who can speak and understand Turkish will be included in the research.
Key exclusion criteria (6 listed)
- Using insulin,
- Diagnosed with malignant tumor,
- Having deep vein thrombosis and heart failure diagnosed by a physician,
- Those with missing limbs or infected, open wounds in the application areas,
- Pregnant and
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 |
|---|---|---|
| lymphatic drainage massageBefore the application, the patient will be placed in a supine position and the feet will be elevated to 45 degrees by the researcher. After the infraclavicular lymph node, located at the point where the veins in the neck area meet the thymus gland, is stimulated with a pumping action, lower extremity applications will be started in the form of upper legs, lower legs and feet; By stimulating the inguinal lymph node in the upper leg application, the popliteal lymph node in the lower leg application, and the medial malleolus lymph node in the foot application, the mobility of the lymph fluid in the direction of the stimulated lymph node is used using "stroking, pumping, circular movements or rolling movements" according to the weight characteristic, body type and preference of the patient. will be provided. Finally, passive exercise will be performed 5 times, repeating both legs in flexion and extension positions, and the infraclavicular lymph node will be stimulated. | Other | Lymphatic drainage massage |
| classic massageThe application will be done by the researcher. The order of application is upper leg, lower leg and feet. During the application, appropriate methods such as effleurage (stroking), kneading, friction, impact and vibration will be used. The application will start with efflorescence and end with the same technique. To the upper leg; Starting from the knee to the groin, to the lower leg; The application will be made in the direction of the muscle fibers, starting from the ankle to the knee. Appropriate techniques will be used depending on the characteristics of the application areas, and each technique will be repeated 5-10 times. In the final stage, passive exercise will be performed by moving to the foot and applying flexion and extension to the ankle 5 times. The application will be completed by applying similar applications to the upper and lower legs on the back of the foot and the outer and lower surface of the foot. Olive oil will be used as essential oil during application. | Other | Classic massage |
Primary outcome
Interdialytic weight gain
Time frame: Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application
In hemodialysis centers, patients' weights are measured and recorded with an electronic scale by the healthcare personnel working in the institution before and after each hemodialysis session. Measurements are made by removing the patients' jackets/coats and shoes. The measurements will be recorded in kilograms by the researcher and weekly interdialytic weight gain will be evaluated.
Fatigue evaluated using the Fatigue Severity Scale
Time frame: Change before the application and 4th week of the application
The Turkish validity and reliability of the scale, which was developed by Krupp et al. in 1989, was tested by Armutlu et al. in 2007, and the Cronbach's alpha coefficient was found to be 0.89, and the test-retest reliability was 0.81 (p = 0.719, within 99% confidence interval). The scale, which evaluates individuals' fatigue status in the last month, consists of a total of 9 items and each item is scored between 1-7. "Strongly disagree = 1", "moderately disagree = 2", "somewhat disagree = 3", "neither agree nor disagree = 4", "somewhat agree = 5", "moderately agree = 6", "strongly agree = It is evaluated as 7" points. The total score calculation of the scale is calculated by adding up the scores given to each item to 9. It is done by dividing. The lowest score that can be obtained from the scale is 1 and the highest score is 7. A total score of 4 or more from the scale indicates severe fatigue. A higher score indicates increased fatigue.
2 secondary outcomes
Blood pressure measurement
Time frame: Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application
Evaluation of biochemical findings
Time frame: Change before the application and 4th week of the application
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 10 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphatic drainage massage and classic massage in people with Interdialytic Weight Gain and Fatigue, run by Mersin University at 2 sites in Turkey (Türkiye).
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 5 inclusion and 6 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Interdialytic weight gain (time frame: Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.