Manual Lymphatic Drainage Versus Classical Massage on Heart Responses and Mood in Hemodialysis

November 6, 2026 updated by: Melike Davarcı, Mersin University

Acute Effects of Manual Lymphatic Drainage and Classical Massage on Cardiovascular and Autonomic Responses and Mood in Patients Undergoing Hemodialysis: A Randomized Controlled Crossover Experimental Study

The goal of this randomized controlled crossover trial is to learn whether manual lymphatic drainage (MLD) and classical massage have different short-term effects on the heart, the nervous system, and mood in adults aged 18 to 65 receiving hemodialysis. A total of 60 patients from two hemodialysis centers in Tarsus, Mersin, Türkiye, are planned to take part.

The main questions it aims to answer are:

  • Do MLD and classical massage differ in their short-term effects on autonomic nervous system responses, measured by heart rate variability (SDNN, RMSSD, LF, HF, LF/HF)? (Primary hypothesis 1)
  • Do MLD and classical massage differ in their short-term effects on cardiovascular responses, measured by systolic and diastolic blood pressure and heart rate? (Primary hypothesis 2)
  • Do MLD and classical massage differ in their short-term effects on mood (fatigue, vigor, tension, and confusion), measured by the Profile of Mood States - Short Form? (Secondary hypothesis)

Researchers will compare MLD with classical massage (active comparator). Each participant will receive both massages in a randomly assigned order (MLD first or classical massage first), so each participant serves as their own control. In addition, a no-massage control measurement will be taken in the week before the massages to show the changes caused by the hemodialysis session alone.

Participants will:

  • In the first week (control period), have their blood pressure, heart rate, and heart rate variability measured three times during a hemodialysis session without any massage.
  • In the second week, receive a 20-minute MLD or classical massage on both legs (thigh, lower leg, and foot), starting one hour after the beginning of the hemodialysis session.
  • After a one-week break (washout period), receive the other type of massage in the same way.
  • Have their blood pressure, heart rate, and heart rate variability measured before each massage, right after it, and 30 minutes later. Heart rate variability will be recorded for 5 minutes with a chest strap.
  • Complete a short mood questionnaire.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular disease is the leading cause of death in patients receiving hemodialysis (HD), accounting for about half of all deaths in this group. Blood pressure variability during dialysis is closely linked to cardiovascular events, and autonomic imbalance contributes to complications such as intradialytic hypotension and hypertension, each affecting about 15% of patients. Heart rate variability (HRV) is a non-invasive indicator of cardiac autonomic regulation and is reduced in chronic kidney disease. In addition, anxiety and depressive symptoms are common in HD patients and are associated with lower quality of life. Therefore, cardiovascular, autonomic, and emotional responses should be considered together during HD.

Massage is a low-cost, easy-to-apply, non-invasive nursing intervention with a low risk of serious side effects. Mechanical stimulation of the skin, muscle, and fascia may influence autonomic nervous system activity. Manual lymphatic drainage (MLD) is a technique that uses light, slow, rhythmic pressure to support lymphatic flow and has been associated with parasympathetic activation and relaxation. However, evidence on the cardiovascular and autonomic effects of MLD is limited, and its acute effects when applied during HD have not been studied.

Aim

The aim of this study is to evaluate and compare the acute cardiovascular, autonomic, and mood effects of 20-minute MLD and 20-minute classical massage applied during hemodialysis. The study is expected to help identify manual techniques that support cardiovascular and autonomic balance and to contribute to the development of evidence-based, non-pharmacological nursing interventions for HD care.

Originality

Previous massage studies in HD patients have mainly focused on symptoms and quality of life, such as fatigue, restless legs syndrome, muscle cramps, and sleep quality. Studies on the autonomic effects of MLD have mostly been conducted in healthy or stressed individuals. To the investigators' knowledge, no study has directly compared MLD and classical massage in terms of acute cardiovascular and autonomic responses in HD patients. This study is original in that:

  • It evaluates HRV together with blood pressure and heart rate, allowing a multidimensional assessment of the acute physiological responses to two manual techniques during HD.
  • It assesses acute changes in mood within a single dialysis session, whereas previous studies have focused on long-term psychological outcomes.
  • It uses a crossover design in which each participant receives both interventions and serves as their own control, which reduces between-subject variability and increases statistical power.
  • The interventions are applied during the dialysis session and can be integrated into routine care without adding extra time burden for patients.

Hypotheses

In hemodialysis patients, the effects of 20-minute MLD and 20-minute classical massage:

  • Primary Hypothesis 1 (H1): differ in terms of acute autonomic responses (HRV).
  • Primary Hypothesis 2 (H2): differ in terms of acute cardiovascular responses (systolic and diastolic blood pressure, heart rate).
  • Secondary Hypothesis (H3): differ in terms of acute mood.

Methods

Design: Two-period, two-sequence (AB/BA), randomized controlled crossover study.

Participants: Patients aged 18 to 65 years who have received HD for at least three months, three times a week, about four hours per session. Main exclusion criteria are conditions preventing massage (e.g., foot ulcer, amputation, orthopedic problems), cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, lupus, diagnosed psychiatric illness, use of sleeping pills or sedatives, atrial fibrillation, and pacemaker use.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being between 18 and 65 years of age
  • Having received hemodialysis treatment for at least three months
  • Receiving hemodialysis treatment at least three times a week, each session lasting approximately four hours
  • Volunteering to participate in the study and providing written informed consent

Exclusion Criteria:

  • Having a medical condition that would prevent the intervention, such as a foot ulcer, amputation, or an orthopedic problem
  • Having a chronic disease such as cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, or lupus erythematosus
  • Having been diagnosed with a psychiatric illness such as depression or bipolar disorder
  • Having a history of a pathological condition, injury, or surgical procedure that would prevent the intervention from being performed safely
  • Using sleeping pills or sedatives, as these may affect autonomic responses and HRV measurements
  • Having a history of atrial fibrillation or having a pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MLD then Classical Massage (AB)

Participants will undergo a no-intervention control measurement (Z0), then receive 20 minutes of manual lymphatic drainage on both lower extremities during hemodialysis in Period 1, and after a one-week washout period, 20 minutes of classical massage in Period 2.
Other: Manual Lymphatic Drainage

20-minute MLD applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using light, slow, rhythmic, superficial stroking, pumping, circular, and rotary maneuvers directed toward the inguinal, popliteal, and medial malleolar lymphatic regions.

Other: Classical Massage

20-minute classical massage applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using effleurage, petrissage, and friction, beginning and ending with effleurage.
Experimental: Classical Massage then MLD (BA)

Participants will undergo a no-intervention control measurement (Z0), then receive 20 minutes of classical massage on both lower extremities during hemodialysis in Period 1, and after a one-week washout period, 20 minutes of manual lymphatic drainage in Period 2.
Other: Manual Lymphatic Drainage

20-minute MLD applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using light, slow, rhythmic, superficial stroking, pumping, circular, and rotary maneuvers directed toward the inguinal, popliteal, and medial malleolar lymphatic regions.

Other: Classical Massage

20-minute classical massage applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using effleurage, petrissage, and friction, beginning and ending with effleurage.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Standard Deviation of Normal-to-Normal Intervals (SDNN)
Time Frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Root Mean Square of Successive Differences (RMSSD)
Time Frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Low Frequency (LF) Power
Time Frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
High Frequency (HF) Power
Time Frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Low Frequency to High Frequency Ratio (LF/HF)
Time Frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Systolic Blood Pressure
Time Frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Diastolic Blood Pressure
Time Frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Heart Rate
Time Frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Fatigue Subscale Score of the Profile of Mood States - Short Form
Time Frame: Before and immediately after the 20-minute intervention, in each intervention period
Before and immediately after the 20-minute intervention, in each intervention period
Vigor Subscale Score of the Profile of Mood States - Short Form
Time Frame: Before and immediately after the 20-minute intervention, in each intervention period
Before and immediately after the 20-minute intervention, in each intervention period
Tension Subscale Score of the Profile of Mood States - Short Form
Time Frame: Before and immediately after the 20-minute intervention, in each intervention period
Before and immediately after the 20-minute intervention, in each intervention period
Confusion Subscale Score of the Profile of Mood States - Short Form
Time Frame: Before and immediately after the 20-minute intervention, in each intervention period
Before and immediately after the 20-minute intervention, in each intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3715103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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