Chronic Kidney DiseaseNCT06759376
Vibration Massage, Static Stretching Exercise, Intradialytic Muscle Cramps and Stress
A study testing Vibration massage and Static stretching exercise in people with Chronic Kidney Disease and Hemodialysis, run by Figen Akay at 1 site in Turkey (Türkiye).
Trial summary
Chronic kidney disease (CKD) is characterised by kidney damage that persists for 3 months or longer or an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² and is assessed in 6 categories. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hemodialysis, Stress
- What is being tested?
- Vibration massage and Static stretching exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2025to 21 Feb 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and over, conscious, Turkish speaking and understanding, accepting the research,
- Patients with normal body mass index (18.5-24.9) [Since body mass can affect the distribution of vibration and cortisol level, it was planned to include patients with normal body mass index in the sample].
- Patients with intradialytic muscle cramp in the lower extremities will be included [Although intradialytic cramp often occurs in the lower extremities, vibration massage and static stretching exercise will be applied to the same muscle group (gastrocnemius and soleus muscles) in the lower extremities to keep the variables under control].
Who cannot join
- Intradialytic muscle cramps in the upper extremity,
- Intradialytic muscle cramps, those with incomplete tissue integrity in the region and thrombophlebitis, hematoma, etc. [In order for vibration massage to be performed, individuals must have skin integrity and normal blood characteristics.]
- Those with foot deformation,
- Those who use anti-inflammatory, analgesic drugs and those who additionally use adjuvant therapy (antidepressants, anticonvulsants, muscle relaxants, etc.) up to 4 hours before the HD session, as intradialytic muscle cramps and their duration may be affected,
- Those who are taking routine cortisone treatment and medications with hormonal effects (oral contraceptives, steroid-containing bronchodilators, etc.) so that the salivary cortisol test is not affected.
- --Alcohol users,
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- Hypoglycemic patients,
- Patients with psychiatric diagnosis and those using medication related to this diagnosis,
- Patients with mouth ulcers, inflammation, etc.
- Patients who ate or drank anything other than water, chewed gum, or consumed foods or beverages containing citric acid 15 minutes before intradialytic muscle cramping,
- Patients who use high doses of biotin (>5 mg/day) and whose last biotin treatment has not passed 8 hours.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Anatolian Dialysis Center
Eskişehir, Turkiye
About this study
Official title: Effects of Vibration Massage and Static Stretching Exercise on Intradialytic Muscle Cramp and Salivary Cortisol Levels: A Randomized Controlled Trial
Chronic kidney disease (CKD) is characterised by kidney damage that persists for 3 months or longer or an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² and is assessed in 6 categories. According to this categorisation, when stage 4 CKD progresses, patients are offered several options for renal replacement therapy. In the last stage of CKD, stage 5, renal replacement therapies including dialysis and kidney transplantation are used. Haemodialysis (HD) is a frequently used life-saving treatment method that removes harmful waste substances accumulated in the body, helps to maintain kidney function, provides fluid-electrolyte balance, prolongs life by managing uremic symptoms. Patients with ESRD are exposed to many health problems such as water-salt balance abnormalities, hypertension, hyperkalemia, metabolic acidosis, hyperphosphatemia, anaemia, cardiovascular disease. While the problems experienced are controlled with HD treatment, the treatment process and the continuation of life dependent on a machine cause life-threatening acute (hypotension, nausea, vomiting, muscle cramps, itching, pain, etc.) and chronic complications (pericarditis, hypertension, anaemia, hepatitis infections, etc.). In addition, due to these complications, HD patients may have problems that cannot be ignored such as deterioration in general health perception, sleep disturbance, anxiety, depression, stress, and difficulties in fulfilling responsibilities due to psychosocial problems. Intradialytic muscle cramp, which develops acutely during HD and is experienced at least once by patients, frequently manifests as involuntary muscle contractions in the lower extremities. The aetiology of intradialytic muscle cramp includes hypotension, electrolyte mineral disorders, high ultrafiltration (UF), excess weight gain between two HDs and carnitine deficiency. In the pharmacological treatment of this complication, which should be managed acutely, intravenous saline solution and hypertonic glucose administration are prominent, but high-quality evidence on the effectiveness of these treatments is needed. While the results of interventions such as aromatherapy, reflexology, massage, stretching-relaxation exercises, hot-cold applications etc. in intradialytic muscle cramp have been reached, the lack of evidence for vibration massage is striking. Management of intradialytic muscle cramp is important for the HD adequacy of patients and failure to manage it may lead to fatal complications such as hypertension, hypervolemia, pulmonary oedema and left ventricular failure due to inadequate HD sessions. It has also been reported that sleep and quality of life are adversely affected in cases where intradialytic muscle cramp cannot be managed; shortening of one HD session per week leads to increased mortality rates, depression and anxiety levels and stress. Salivary cortisol is a useful biomarker often used as a marker of psychological stress. Salivary cortisol levels peak approximately 20 minutes after an acute stress event. Massage, which is among independent nursing interventions, is a manipulation that provides physical and psychological relaxation by mechanically stimulating muscle tissues. During massage, nurses can apply euphlorage, petrissage, friction, tapotman and vibration. Vibration massage is applied to improve muscle atrophy and bone density caused by microgravity and immobilisation. Static stretching exercise, another intervention in intradialytic muscle cramp management, reduces muscle stiffness and tension by increasing muscle flexibility and range of motion by stimulating neural activities. These exercises reduce the risk of injury to joints, muscles and tendons by stimulating the formation of chemicals that allow the connective tissue to move easily and are recommended for the prevention of muscle cramps.
Read the detailed description
Key words: Vibration massage, Static stretching exercise, Intradialytic muscle cramp, Salivary cortisol level, stress.
Study design: Randomised controlled trial. Objectives:The aim of this randomised controlled clinical trial was to evaluate the effect of vibration massage and static stretching exercise on intradialytic muscle cramp (severity and duration) and salivary cortisol levels during intradialytic muscle cramp.
Phase of the study: For this study, permission was obtained from Eskişehir Osmangazi University Clinical Research Ethics Committee that there was no ethical objection. For the financial support of the study, an application was made to the Scientific and Technological Research Council of Türkiye (TUBITAK), a state institution in Turkey, and the result is awaited. After approval, the data collection phase will begin.
Interventional Study Model: Factorial Vibration massage group (Group A), Static stretching exercise (Group B), Control Group (Group C).
Masking: Outcomes Assessor. Allocation: Stratified Randomized. Enrollment: The total number of participants to be enrolled in the clinical study was determined as 30.
Biospecimen Retention: Collection of saliva for salivary cortisol testing at the time of intradialytic muscle cramp and at 20 minutes after the patients to be included in the study.
Target Follow-Up Duration: Participants will be followed up at the time of intradialytic muscle cramp and at the time of its termination.
Intervention First intervention group: Vibration massage (Group A).
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- 10 minutes of vibration massage,
- VAS questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
The second group of intervention: Static stretching exercise (Group B)
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- Perform static stretching exercise for 10 minutes,
- VAS questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
Control group: Usual care (Group C)
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- Usual care,
- VAS questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
Outcome Measures
Primary Outcome Measure Information:
- The effect of vibration massage on the severity, duration and salivary cortisol level of intradialytic muscle cramp.
- The effect of static stretching exercise on intradialytic muscle cramp severity, duration and salivary cortisol level.
- To determine which intervention (vibration massage and static stretching exercise) is more effective on intradialytic muscle cramp severity, duration and salivary cortisol level.
Secondary Outcome Measure: The effectiveness of vibration massage and stretching exercise interventions for acute stress management will be determined.
Age Limits: Patients aged 18 years and older. Eligibility Criteria: 18 years of age and over, conscious, Turkish speaking and understanding, accepting the research, With a normal body mass index (18.5-24.9), Patients with intradialytic muscle cramps in the lower limb.
Statistical Analysis Plan: The data obtained in the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 programme. The statistician performing the statistics of the data will not be informed which group the patients are in and the interventions applied to the groups, thus statistical blinding will be ensured. Kolmogorov Smirnov Test will be used to determine whether the research data are normally distributed. According to the Kolmogorov Smirnov Test, if p>0.05, it is determined that the distribution is normal. However, if p<0.05, it is determined that the distribution is not normal and the Skewness and Kurtosis values of the data are examined. If Skewness and Kurtosis values are between +2 and -2, it is accepted that the variable shows normal distribution. Homogeneity of descriptive characteristics between groups will be tested by chi-square analysis. For the difference between group averages, one-way analysis of variance will be used if the data are normally distributed, and Kruskal Wallis test will be used if the data are not normally distributed. Changes in measurements within the group will be analysed by repeated measures ANOVA test if the data are normally distributed, and by Friedman test if the data are not normally distributed.
Informed Consent Form: Informed Voluntary Consent signature will be obtained from patients who agree to participate in the study. The research will be conducted in accordance with the Declaration of Helsinki.
- Conditions
- Chronic Kidney Disease, Hemodialysis, Stress
- Being tested
- Vibration massage, Static stretching exercise, Usual Care
- Keywords
- Hemodialysis, Stress, intradialytic muscle cramp, Nurse, Vibration Massage, Salivary Cortisol, Static Stretching Exercise
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration massageOther
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- Performing vibration massage with a vibration massage device for 10 minutes,
- Visual Analog Scale questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
Static stretching exerciseOther
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- Perform static stretching exercise for 10 minutes,
- Visual Analog Scale questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
Usual CareOther
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- Usual care,
- Visual Analog Scale questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
| Study group | Role | What they receive |
|---|---|---|
| Vibration (Group A) | Experimental | Vibration massage Receives: Other: Vibration massage |
| Stretching (Group B) | Experimental | Static stretching exercise Receives: Other: Static stretching exercise |
| Control (Group C) | Other | Usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
intradialytic muscle cramp (severity)
- Visual Analog Scale questioning will be performed every 2 minutes during the intradialytic cramp period.
- The effect of 10 minutes of vibration massage and static stretching exercise interventions on the severity of intradialytic muscle cramp will be examined.
Measured: 1 year
Salivary cortisol levels
- The stress level of the patient during intradialytic muscle cramp will be quantitatively assessed by salivary cortisol testing.
- Salivary cortisol tests will be taken again at 20 minutes to evaluate the effectiveness of vibration massage and static stretching exercise interventions applied to intradialytic muscle cramp for 10 minutes and to evaluate which intervention is superior.
- The effect of vibration massage and static stretching exercise on salivary cortisol level will be evaluated.
Measured: 1 year
intradialytic muscle cramp (duration)
- Intradialytic muscle cramp duration will be measured with a stopwatch.
- The effect of 10 minutes of vibration massage and static stretching exercise interventions on muscle cramp duration will be examined.
Measured: 1 year
Secondary outcomes (2)
Heart rate
The effects of interventions applied for intradialytic muscle cramps on heart rate were evaluated.
Measured: 1 years
Systolic and Diastolic Blood Pressure
The effect of interventions applied for intradialytic muscle cramps on blood pressure was evaluated.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start21 Nov 2025
- Primary completion21 Feb 2026
- Study completion21 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Figen Akay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Figen Akay, Eskisehir Osmangazi University
- Investigators
- Ayşe Özkaraman, Professor, Study director, Eskisehir Osmangazi University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759376
- Sponsor's protocol ID
- E-80558721-050.04-240188711
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary data can be provided starting 6 months after publication.
Publications
Zoccali C, Mallamaci F, Adamczak M, de Oliveira RB, Massy ZA, Sarafidis P, Agarwal R, Mark PB, Kotanko P, Ferro CJ, Wanner C, Burnier M, Vanholder R, Wiecek A. Cardiovascular complications in chronic kidney disease: a review from the European Renal and Cardiovascular Medicine Working Group of the European Renal Association. Cardiovasc Res. 2023 Sep 5;119(11):2017-2032. doi: 10.1093/cvr/cvad083.
PubMed 37249051Youdas JW, Krause DA, Egan KS, Therneau TM, Laskowski ER. The effect of static stretching of the calf muscle-tendon unit on active ankle dorsiflexion range of motion. J Orthop Sports Phys Ther. 2003 Jul;33(7):408-17. doi: 10.2519/jospt.2003.33.7.408.
PubMed 12918866Yilmaz Menek M, Dansuk E, Tayboga UI. Effect of Local Vibration Therapy on Pain, Joint Position Sense, Kinesiophobia, and Disability in Cervical Disc Herniation: A Randomized Controlled Trial. J Clin Med. 2024 Aug 5;13(15):4566. doi: 10.3390/jcm13154566.
PubMed 39124832Trajano GS, Taylor JL, Orssatto LBR, McNulty CR, Blazevich AJ. Passive muscle stretching reduces estimates of persistent inward current strength in soleus motor units. J Exp Biol. 2020 Nov 5;223(Pt 21):jeb229922. doi: 10.1242/jeb.229922.
PubMed 32978317Skrinjar I, Loncar Brzak B, Vidranski V, Vucicevic Boras V, Rogulj AA, Pavelic B. Salivary Cortisol Levels and Burning Symptoms in Patients with Burning Mouth Syndrome before and after Low Level Laser Therapy: a Double Blind Controlled Randomized Clinical Trial. Acta Stomatol Croat. 2020 Mar;54(1):44-50. doi: 10.15644/asc54/1/5.
PubMed 32523156Suleymanlar G, Utas C, Arinsoy T, Ates K, Altun B, Altiparmak MR, Ecder T, Yilmaz ME, Camsari T, Basci A, Odabas AR, Serdengecti K. A population-based survey of Chronic REnal Disease In Turkey--the CREDIT study. Nephrol Dial Transplant. 2011 Jun;26(6):1862-71. doi: 10.1093/ndt/gfq656. Epub 2010 Nov 4.
PubMed 21051501Needs D, Blotter J, Cowan M, Fellingham G, Johnson AW, Feland JB. Effect of Localized Vibration Massage on Popliteal Blood Flow. J Clin Med. 2023 Mar 4;12(5):2047. doi: 10.3390/jcm12052047.
PubMed 36902835Mastnardo D, Lewis JM, Hall K, Sullivan CM, Cain K, Theurer J, Huml A, Sehgal AR. Intradialytic Massage for Leg Cramps Among Hemodialysis Patients: a Pilot Randomized Controlled Trial. Int J Ther Massage Bodywork. 2016 Jun 3;9(2):3-8. doi: 10.3822/ijtmb.v9i2.305. eCollection 2016 Jun.
PubMed 27257445Mantilla-Manosalva N, Guadarrama S, Bedoya-Munoz LJ, Giraldo-Moreno S, Cuellar-Valencia L, Iriarte-Aristizabal MF, Leon MX, Mendoza-Montenegro FA, Correa-Morales JE. Pharmacological Treatment for Dialysis-Related Muscle Cramps: A Systematic Review. Semin Dial. 2024 Nov-Oct;37(6):415-423. doi: 10.1111/sdi.13223. Epub 2024 Aug 18.
PubMed 39155056Lupowitz L. Vibration Therapy - A Clinical Commentary. Int J Sports Phys Ther. 2022 Aug 1;17(6):984-987. doi: 10.26603/001c.36964. eCollection 2022. No abstract available.
PubMed 36237646Lee DY, Kim E, Choi MH. Technical and clinical aspects of cortisol as a biochemical marker of chronic stress. BMB Rep. 2015 Apr;48(4):209-16. doi: 10.5483/bmbrep.2015.48.4.275.
PubMed 25560699Imai T, Nagamatsu T, Yoshizato Y, Miyara K, Sumizono M, Nakamura M. Acute Effects of Handheld Vibration Massage on Posterior Shoulder Soft Tissues. Int J Sports Phys Ther. 2024 Aug 2;19(8):1003-1011. doi: 10.26603/001c.121299. eCollection 2024.
PubMed 39100939Hill NR, Fatoba ST, Oke JL, Hirst JA, O'Callaghan CA, Lasserson DS, Hobbs FD. Global Prevalence of Chronic Kidney Disease - A Systematic Review and Meta-Analysis. PLoS One. 2016 Jul 6;11(7):e0158765. doi: 10.1371/journal.pone.0158765. eCollection 2016.
PubMed 27383068Higaki Y, Yamato Y, Fujie S, Inoue K, Shimomura M, Kato S, Horii N, Ogoh S, Iemitsu M. Acute effects of the different relaxation periods during passive intermittent static stretching on arterial stiffness. PLoS One. 2021 Nov 15;16(11):e0259444. doi: 10.1371/journal.pone.0259444. eCollection 2021.
PubMed 34780500Heo EH, Kim S, Park HJ, Kil SY. The effects of a simulated laughter programme on mood, cortisol levels, and health-related quality of life among haemodialysis patients. Complement Ther Clin Pract. 2016 Nov;25:1-7. doi: 10.1016/j.ctcp.2016.07.001. Epub 2016 Jul 27.
PubMed 27863598
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibration Massage and Static Stretching Exercise on Intradialytic Muscle Cramp and Salivary Cortisol Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06759376
- Acronym / sponsor ID
- E-80558721-050.04-240188711
- Conditions
- Chronic Kidney Disease, Hemodialysis, Stress
- Keywords
- Hemodialysis, Stress, intradialytic muscle cramp, Nurse, Vibration Massage, Salivary Cortisol, Static Stretching Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Figen AkayUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 21 Feb 2026 (actual)
- Study completion
- 21 Feb 2026 (actual)
- First posted
- 6 Jan 2025 (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.
Chronic kidney disease (CKD) is characterised by kidney damage that persists for 3 months or longer or an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² and is assessed in 6 categories. According to this categorisation, when stage 4 CKD progresses, patients are offered several options for renal replacement therapy. In the last stage of CKD, stage 5, renal replacement therapies including dialysis and kidney transplantation are used. Haemodialysis (HD) is a frequently used life-saving treatment method that removes harmful waste substances accumulated in the body, helps to maintain kidney function, provides fluid-electrolyte balance, prolongs life by managing uremic symptoms. Patients with ESRD are exposed to many health problems such as water-salt balance abnormalities, hypertension, hyperkalemia, metabolic acidosis, hyperphosphatemia, anaemia, cardiovascular disease. While the problems experienced are controlled with HD treatment, the treatment process and the continuation of life dependent on a machine cause life-threatening acute (hypotension, nausea, vomiting, muscle cramps, itching, pain, etc.) and chronic complications (pericarditis, hypertension, anaemia, hepatitis infections, etc.). In addition, due to these complications, HD patients may have problems that cannot be ignored such as deterioration in general health perception, sleep disturbance, anxiety, depression, stress, and difficulties in fulfilling responsibilities due to psychosocial problems. Intradialytic muscle cramp, which develops acutely during HD and is experienced at least once by patients, frequently manifests as involuntary muscle contractions in the lower extremities. The aetiology of intradialytic muscle cramp includes hypotension, electrolyte mineral disorders, high ultrafiltration (UF), excess weight gain between two HDs and carnitine deficiency. In the pharmacological treatment of this complication, which should be managed acutely, intravenous saline solution and hypertonic glucose administration are prominent, but high-quality evidence on the effectiveness of these treatments is needed. While the results of interventions such as aromatherapy, reflexology, massage, stretching-relaxation exercises, hot-cold applications etc. in intradialytic muscle cramp have been reached, the lack of evidence for vibration massage is striking. Management of intradialytic muscle cramp is important for the HD adequacy of patients and failure to manage it may lead to fatal complications such as hypertension, hypervolemia, pulmonary oedema and left ventricular failure due to inadequate HD sessions. It has also been reported that sleep and quality of life are adversely affected in cases where intradialytic muscle cramp cannot be managed; shortening of one HD session per week leads to increased mortality rates, depression and anxiety levels and stress. Salivary cortisol is a useful biomarker often used as a marker of psychological stress. Salivary cortisol levels peak approximately 20 minutes after an acute stress event. Massage, which is among independent nursing interventions, is a manipulation that provides physical and psychological relaxation by mechanically stimulating muscle tissues. During massage, nurses can apply euphlorage, petrissage, friction, tapotman and vibration. Vibration massage is applied to improve muscle atrophy and bone density caused by microgravity and immobilisation. Static stretching exercise, another intervention in intradialytic muscle cramp management, reduces muscle stiffness and tension by increasing muscle flexibility and range of motion by stimulating neural activities. These exercises reduce the risk of injury to joints, muscles and tendons by stimulating the formation of chemicals that allow the connective tissue to move easily and are recommended for the prevention of muscle cramps.
Detailed description
Key words: Vibration massage, Static stretching exercise, Intradialytic muscle cramp, Salivary cortisol level, stress.
Study design: Randomised controlled trial. Objectives:The aim of this randomised controlled clinical trial was to evaluate the effect of vibration massage and static stretching exercise on intradialytic muscle cramp (severity and duration) and salivary cortisol levels during intradialytic muscle cramp.
Phase of the study: For this study, permission was obtained from Eskişehir Osmangazi University Clinical Research Ethics Committee that there was no ethical objection. For the financial support of the study, an application was made to the Scientific and Technological Research Council of Türkiye (TUBITAK), a state institution in Turkey, and the result is awaited. After approval, the data collection phase will begin.
Interventional Study Model: Factorial Vibration massage group (Group A), Static stretching exercise (Group B), Control Group (Group C).
Masking: Outcomes Assessor. Allocation: Stratified Randomized. Enrollment: The total number of participants to be enrolled in the clinical study was determined as 30.
Biospecimen Retention: Collection of saliva for salivary cortisol testing at the time of intradialytic muscle cramp and at 20 minutes after the patients to be included in the study.
Target Follow-Up Duration: Participants will be followed up at the time of intradialytic muscle cramp and at the time of its termination.
Intervention First intervention group: Vibration massage (Group A).
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- 10 minutes of vibration massage,
- VAS questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
The second group of intervention: Static stretching exercise (Group B)
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- Perform static stretching exercise for 10 minutes,
- VAS questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
Control group: Usual care (Group C)
- Initiation of the stopwatch with the onset of intradialytic muscle cramp,
- Taking a salivary cortisol test,
- Usual care,
- VAS questioning every 2 minutes during intradialytic muscle cramp,
- Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended,
- Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp.
Outcome Measures
Primary Outcome Measure Information:
- The effect of vibration massage on the severity, duration and salivary cortisol level of intradialytic muscle cramp.
- The effect of static stretching exercise on intradialytic muscle cramp severity, duration and salivary cortisol level.
- To determine which intervention (vibration massage and static stretching exercise) is more effective on intradialytic muscle cramp severity, duration and salivary cortisol level.
Secondary Outcome Measure: The effectiveness of vibration massage and stretching exercise interventions for acute stress management will be determined.
Age Limits: Patients aged 18 years and older. Eligibility Criteria: 18 years of age and over, conscious, Turkish speaking and understanding, accepting the research, With a normal body mass index (18.5-24.9), Patients with intradialytic muscle cramps in the lower limb.
Statistical Analysis Plan: The data obtained in the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 programme. The statistician performing the statistics of the data will not be informed which group the patients are in and the interventions applied to the groups, thus statistical blinding will be ensured. Kolmogorov Smirnov Test will be used to determine whether the research data are normally distributed. According to the Kolmogorov Smirnov Test, if p>0.05, it is determined that the distribution is normal. However, if p<0.05, it is determined that the distribution is not normal and the Skewness and Kurtosis values of the data are examined. If Skewness and Kurtosis values are between +2 and -2, it is accepted that the variable shows normal distribution. Homogeneity of descriptive characteristics between groups will be tested by chi-square analysis. For the difference between group averages, one-way analysis of variance will be used if the data are normally distributed, and Kruskal Wallis test will be used if the data are not normally distributed. Changes in measurements within the group will be analysed by repeated measures ANOVA test if the data are normally distributed, and by Friedman test if the data are not normally distributed.
Informed Consent Form: Informed Voluntary Consent signature will be obtained from patients who agree to participate in the study. The research will be conducted in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vibration (Group A) | Experimental | Other: Vibration massageVibration massage |
| Stretching (Group B) | Experimental | Other: Static stretching exerciseStatic stretching exercise |
| Control (Group C) | Other | Other: Usual CareUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and over, conscious, Turkish speaking and understanding, accepting the research,
- Patients with normal body mass index (18.5-24.9) [Since body mass can affect the distribution of vibration and cortisol level, it was planned to include patients with normal body mass index in the sample].
- Patients with intradialytic muscle cramp in the lower extremities will be included [Although intradialytic cramp often occurs in the lower extremities, vibration massage and static stretching exercise will be applied to the same muscle group (gastrocnemius and soleus muscles) in the lower extremities to keep the variables under control].
Key exclusion criteria (11 listed)
- Intradialytic muscle cramps in the upper extremity,
- Intradialytic muscle cramps, those with incomplete tissue integrity in the region and thrombophlebitis, hematoma, etc. [In order for vibration massage to be performed, individuals must have skin integrity and normal blood characteristics.]
- Those with foot deformation,
- Those who use anti-inflammatory, analgesic drugs and those who additionally use adjuvant therapy (antidepressants, anticonvulsants, muscle relaxants, etc.) up to 4 hours before the HD session, as intradialytic muscle cramps and their duration may be affected,
- Those who are taking routine cortisone treatment and medications with hormonal effects (oral contraceptives, steroid-containing bronchodilators, etc.) so that the salivary cortisol test is not affected.
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 |
|---|---|---|
| Vibration massage* Initiation of the stopwatch with the onset of intradialytic muscle cramp, * Taking a salivary cortisol test, * Performing vibration massage with a vibration massage device for 10 minutes, * Visual Analog Scale questioning every 2 minutes during intradialytic muscle cramp, * Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended, * Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp. | Other | Vibration (Group A) |
| Static stretching exercise* Initiation of the stopwatch with the onset of intradialytic muscle cramp, * Taking a salivary cortisol test, * Perform static stretching exercise for 10 minutes, * Visual Analog Scale questioning every 2 minutes during intradialytic muscle cramp, * Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended, * Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp. | Other | Stretching (Group B) |
| Usual Care* Initiation of the stopwatch with the onset of intradialytic muscle cramp, * Taking a salivary cortisol test, * Usual care, * Visual Analog Scale questioning every 2 minutes during intradialytic muscle cramp, * Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended, * Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp. | Other | Control (Group C) |
Primary outcome
intradialytic muscle cramp (severity)
Time frame: 1 year
* Visual Analog Scale questioning will be performed every 2 minutes during the intradialytic cramp period. * The effect of 10 minutes of vibration massage and static stretching exercise interventions on the severity of intradialytic muscle cramp will be examined.
Salivary cortisol levels
Time frame: 1 year
* The stress level of the patient during intradialytic muscle cramp will be quantitatively assessed by salivary cortisol testing. * Salivary cortisol tests will be taken again at 20 minutes to evaluate the effectiveness of vibration massage and static stretching exercise interventions applied to intradialytic muscle cramp for 10 minutes and to evaluate which intervention is superior. * The effect of vibration massage and static stretching exercise on salivary cortisol level will be evaluated.
intradialytic muscle cramp (duration)
Time frame: 1 year
* Intradialytic muscle cramp duration will be measured with a stopwatch. * The effect of 10 minutes of vibration massage and static stretching exercise interventions on muscle cramp duration will be examined.
2 secondary outcomes
Heart rate
Time frame: 1 years
Systolic and Diastolic Blood Pressure
Time frame: 1 years
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 Aug 2026.
- Background: PubMed 37249051Zoccali C, Mallamaci F, Adamczak M, de Oliveira RB, Massy ZA, Sarafidis P, Agarwal R, Mark PB, Kotanko P, Ferro CJ, Wanner C, Burnier M, Vanholder R, Wiecek A. Cardiovascular complications in chronic kidney disease: a review from the European Renal and Cardiovascular Medicine Working Group of the European Renal Association. Cardiovasc Res. 2023 Sep 5;119(11):2017-2032. doi: 10.1093/cvr/cvad083.
- Background: PubMed 12918866Youdas JW, Krause DA, Egan KS, Therneau TM, Laskowski ER. The effect of static stretching of the calf muscle-tendon unit on active ankle dorsiflexion range of motion. J Orthop Sports Phys Ther. 2003 Jul;33(7):408-17. doi: 10.2519/jospt.2003.33.7.408.
- Background: PubMed 39124832Yilmaz Menek M, Dansuk E, Tayboga UI. Effect of Local Vibration Therapy on Pain, Joint Position Sense, Kinesiophobia, and Disability in Cervical Disc Herniation: A Randomized Controlled Trial. J Clin Med. 2024 Aug 5;13(15):4566. doi: 10.3390/jcm13154566.
- Background: PubMed 32978317Trajano GS, Taylor JL, Orssatto LBR, McNulty CR, Blazevich AJ. Passive muscle stretching reduces estimates of persistent inward current strength in soleus motor units. J Exp Biol. 2020 Nov 5;223(Pt 21):jeb229922. doi: 10.1242/jeb.229922.
- Background: PubMed 32523156Skrinjar I, Loncar Brzak B, Vidranski V, Vucicevic Boras V, Rogulj AA, Pavelic B. Salivary Cortisol Levels and Burning Symptoms in Patients with Burning Mouth Syndrome before and after Low Level Laser Therapy: a Double Blind Controlled Randomized Clinical Trial. Acta Stomatol Croat. 2020 Mar;54(1):44-50. doi: 10.15644/asc54/1/5.
- Background: PubMed 21051501Suleymanlar G, Utas C, Arinsoy T, Ates K, Altun B, Altiparmak MR, Ecder T, Yilmaz ME, Camsari T, Basci A, Odabas AR, Serdengecti K. A population-based survey of Chronic REnal Disease In Turkey--the CREDIT study. Nephrol Dial Transplant. 2011 Jun;26(6):1862-71. doi: 10.1093/ndt/gfq656. Epub 2010 Nov 4.
- Background: PubMed 36902835Needs D, Blotter J, Cowan M, Fellingham G, Johnson AW, Feland JB. Effect of Localized Vibration Massage on Popliteal Blood Flow. J Clin Med. 2023 Mar 4;12(5):2047. doi: 10.3390/jcm12052047.
- Background: PubMed 27257445Mastnardo D, Lewis JM, Hall K, Sullivan CM, Cain K, Theurer J, Huml A, Sehgal AR. Intradialytic Massage for Leg Cramps Among Hemodialysis Patients: a Pilot Randomized Controlled Trial. Int J Ther Massage Bodywork. 2016 Jun 3;9(2):3-8. doi: 10.3822/ijtmb.v9i2.305. eCollection 2016 Jun.
- Background: PubMed 39155056Mantilla-Manosalva N, Guadarrama S, Bedoya-Munoz LJ, Giraldo-Moreno S, Cuellar-Valencia L, Iriarte-Aristizabal MF, Leon MX, Mendoza-Montenegro FA, Correa-Morales JE. Pharmacological Treatment for Dialysis-Related Muscle Cramps: A Systematic Review. Semin Dial. 2024 Nov-Oct;37(6):415-423. doi: 10.1111/sdi.13223. Epub 2024 Aug 18.
- Background: PubMed 36237646Lupowitz L. Vibration Therapy - A Clinical Commentary. Int J Sports Phys Ther. 2022 Aug 1;17(6):984-987. doi: 10.26603/001c.36964. eCollection 2022. No abstract available.
- Background: PubMed 25560699Lee DY, Kim E, Choi MH. Technical and clinical aspects of cortisol as a biochemical marker of chronic stress. BMB Rep. 2015 Apr;48(4):209-16. doi: 10.5483/bmbrep.2015.48.4.275.
- Background: PubMed 39100939Imai T, Nagamatsu T, Yoshizato Y, Miyara K, Sumizono M, Nakamura M. Acute Effects of Handheld Vibration Massage on Posterior Shoulder Soft Tissues. Int J Sports Phys Ther. 2024 Aug 2;19(8):1003-1011. doi: 10.26603/001c.121299. eCollection 2024.
- Individual participant dataSharing planned: Yes. Summary data can be provided starting 6 months after publication.
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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.
Ayşe Özkaraman, Professor study director
Eskisehir Osmangazi University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration massage and Static stretching exercise in people with Chronic Kidney Disease and Hemodialysis, run by Figen Akay at 1 site 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 3 inclusion and 11 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
intradialytic muscle cramp (severity) (time frame: 1 year). 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 NCT06759376, which also lists 28 linked publications.
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 Aug 2026.