Effects of Manual Lymphatic Drainage and Classical Massage on Autonomic and Hemodynamic Responses in Community-Dwelling Older Adults
The Effects of Manual Lymphatic Drainage and Classical Massage on Autonomic and Hemodynamic Responses in Community-Dwelling Older Adults: A Randomized Controlled Trial
**Study Objective**
The aim of this randomized controlled trial is to evaluate the effects of manual lymphatic drainage massage and classical massage on autonomic and hemodynamic responses in community-dwelling older adults aged 60 years and older. The study is expected to contribute to understanding the effects of massage interventions on autonomic and hemodynamic responses and to the development of evidence-based, non-pharmacological interventions supporting older adults' health.
**Study Hypotheses**
Primary Hypothesis (H01): The effects of a single 15-minute session of manual lymphatic drainage massage and classical massage on cardiac autonomic function in community-dwelling older adults differ from those observed in the delayed-intervention control group.
Secondary Hypothesis (H02): The effects of a single 15-minute session of manual lymphatic drainage massage and classical massage on hemodynamic responses in community-dwelling older adults differ from those observed in the delayed-intervention control group.
**Study Design and Procedures**
A total of 75 participants will be randomly assigned to one of three groups: manual lymphatic drainage massage, classical massage, or a delayed-intervention control group.
Participants in the manual lymphatic drainage massage group will receive a single 15-minute session involving gentle, rhythmic massage techniques applied to the neck and supraclavicular regions. Participants in the classical massage group will receive a single 15-minute session involving traditional massage techniques applied to the neck and shoulders. Participants in the delayed-intervention control group will rest for 15 minutes without receiving massage.
Heart rate variability (HRV), heart rate, and blood pressure will be measured before and immediately after the 15-minute massage or rest period in all three groups. HRV measures the natural variation in time between heartbeats and provides information about the regulation of heart function by the autonomic nervous system.
Changes in these measurements will be compared among the three groups to evaluate short-term autonomic and hemodynamic responses.
After completion of the study, participants in the delayed-intervention control group will be offered a massage intervention based on the study findings.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Gizem Kalay Çelik
- Telefonszám: +905073669252
- E-mail: gizem.kly@hotmail.com
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Being 60 years of age or older.
- Providing written informed consent to participate in the study.
- Voluntarily participating in the study through Yenişehir Egemenlik Family Health Center, Mezitli Nafiz Çolak Family Health Center, or Yenişehir Mimar Sinan Family Health Center in Mersin, Türkiye.
Exclusion Criteria:
- Presence of a cardiac pacemaker or implantable cardioverter-defibrillator (ICD).
- Clinically significant arrhythmias that may affect heart rate variability (HRV).
- Acute or decompensated heart failure.
- Acute deep vein thrombosis (DVT) or thrombophlebitis.
- Acute infection, febrile illness, or active infection in the massage area.
- Open wounds, active dermatological conditions, hematomas, or impaired skin integrity in the massage area.
- Cervical disc herniation.
- Refusal to provide informed consent.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Manual Lymphatic Drainage Massage Group
Participants in this group will receive a single 15-minute manual lymphatic drainage massage session targeting the cervical and supraclavicular regions in the supine position. The massage will follow the basic principles of the Dr. Vodder method, using gentle, rhythmic, superficial pressure and stationary circular movements at a rate of 20-30 movements per minute. Heart rate variability (HRV), heart rate, and blood pressure will be measured before (Z0) and after (Z1) the intervention. |
Participants will be placed in a comfortable supine position with head and neck support. Privacy and hand hygiene will be ensured. Manual lymphatic drainage will follow Dr. Vodder principles, using gentle, rhythmic, superficial pressure without sliding or deep tissue compression. The skin will be gently stretched within its elastic limits and released. Stationary circular movements will be applied from the cervical region toward the supraclavicular terminal area, with very gentle lateral-to-medial movements near the supraclavicular fossa. The massage will last 15 minutes at 20-30 movements per minute, avoiding pain. Afterward, participants will remain supine, be monitored for adverse effects, and undergo post-intervention measurements of heart rate variability (HRV), heart rate, and blood pressure without changing position. |
|
Kísérleti: Classical Massage Group
Participants assigned to this group will receive a single 15-minute classical massage session targeting the neck and shoulder regions bilaterally. The massage will begin with gentle, rhythmic effleurage (stroking), followed by petrissage (kneading) and controlled friction movements, and will end with gentle effleurage. Fragrance-free baby oil without colorants, preservatives, or added vitamins will be used. The massage will be performed without causing pain or discomfort. Heart rate variability (HRV), heart rate, and blood pressure will be measured before (Z0) and after (Z1) the intervention. |
Before the massage, participants will be positioned comfortably, and the neck and shoulders will be prepared. Privacy and hand hygiene will be ensured. Fragrance-free baby oil without colorants, preservatives, or vitamins will be used, and the hands will be warmed. Classical massage will be applied bilaterally to the neck and shoulders using effleurage (stroking), petrissage (kneading), and friction techniques. The session will begin with gentle, rhythmic effleurage, followed by petrissage of the neck and shoulder muscles and controlled friction over appropriate muscle areas. Gentle effleurage will conclude the session. All movements will avoid pain or discomfort. The massage will last 15 minutes to match the MLD-m intervention duration. Afterward, participants will rest, be monitored for adverse effects, and undergo post-intervention measurements of heart rate variability (HRV), heart rate, and blood pressure. |
|
Nincs beavatkozás: Delayed-Intervention Control Group
Participants assigned to the delayed-intervention control group will not receive any massage intervention during the main study period. They will rest for 15 minutes under the same environmental conditions as the intervention groups. Heart rate variability (HRV), heart rate, and blood pressure will be measured before (Z0) and after (Z1) the rest period, using the same measurement intervals as the intervention groups. After completion of the study, participants will be offered one session of the massage intervention found to be more effective based on the study results. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
|---|---|
|
Change in Heart Rate Variability (SDNN)
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
|
Change in Heart Rate Variability (RMSSD)
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
|
Change in Heart Rate Variability (pNN50)
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
|
Change in Heart Rate Variability (LF)
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
|
Change in Heart Rate Variability (HF)
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
|
Change in Heart Rate Variability (LF/HF Ratio)
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Másodlagos eredményintézkedések
Eredménymérő |
Időkeret |
|---|---|
|
Change in Heart Rate
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
|
Change in Systolic Blood Pressure
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
|
Change in Diastolic Blood Pressure
Időkeret: Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Baseline (Z0) and immediately after the 15-minute massage or rest period (Z1)
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 52/505
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
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