Vibration Massage, Static Stretching Exercise, Intradialytic Muscle Cramps and Stress

NCT06759376 | Completed DMC

• 1 other identifier: E-80558721-050.04-240188711
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Kidney Disease; Hemodialysis; Stress

Keywords

Hemodialysis; Stress; intradialytic muscle cramp; Nurse; Vibration Massage; Salivary Cortisol; Static Stretching Exercise

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 year

Secondary Outcomes (1)

• Acute stress

  1 year

Study Arms (3)

Vibration (Group A)

EXPERIMENTAL

Vibration massage

Other: Vibration massage

Stretching (Group B)

EXPERIMENTAL

Static stretching exercise

Other: Static stretching exercise

Control (Group C)

OTHER

Usual care

Other: Usual Care

Interventions

Vibration massage OTHER

* 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.

Vibration (Group A)

Static stretching exercise OTHER

* 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.

Stretching (Group B)

Usual Care OTHER

* 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.

Control (Group C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[Although intradialytic cramp often occurs in the lower extremities, vibration massage and static stretching exercise will be applied to the same muscle group (gastrocnemius and soleus muscles) in the lower extremities to keep the variables under control\].

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Figen Akay: lead

Study Sites (1)

Private Anatolian Dialysis Center

Eskişehir, Turkiye, Turkey (Türkiye)

Location

Related Publications (28)

• 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.

  PMID: 37249051 BACKGROUND

• Youdas 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.

  PMID: 12918866 BACKGROUND

• Yilmaz 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.

  PMID: 39124832 BACKGROUND

• Trajano 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.

  PMID: 32978317 BACKGROUND

• Skrinjar 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.

  PMID: 32523156 BACKGROUND

• Suleymanlar 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.

  PMID: 21051501 BACKGROUND

• Needs 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.

  PMID: 36902835 BACKGROUND

• Mastnardo 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.

  PMID: 27257445 BACKGROUND

• Mantilla-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.

  PMID: 39155056 BACKGROUND

• Lupowitz 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.

  PMID: 36237646 BACKGROUND

• Lee 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.

  PMID: 25560699 BACKGROUND

• Imai 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.

  PMID: 39100939 BACKGROUND

• Hill 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.

  PMID: 27383068 BACKGROUND

• Higaki 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.

  PMID: 34780500 BACKGROUND

• Heo 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.

  PMID: 27863598 BACKGROUND

• Hao G, Lu W, Huang J, Ding W, Wang P, Wang L, Ding F, Hu M, Hou L. Predialysis fluid overload linked with quality of sleep in patients undergoing hemodialysis. Sleep Med. 2018 Nov;51:140-147. doi: 10.1016/j.sleep.2018.07.011. Epub 2018 Jul 31.

  PMID: 30165338 BACKGROUND

• Hassanzadeh M, Kiani F, Bouya S, Zarei M. Comparing the effects of relaxation technique and inhalation aromatherapy on fatigue in patients undergoing hemodialysis. Complement Ther Clin Pract. 2018 May;31:210-214. doi: 10.1016/j.ctcp.2018.02.019. Epub 2018 Mar 6.

  PMID: 29705457 BACKGROUND

• Hargrove N, El Tobgy N, Zhou O, Pinder M, Plant B, Askin N, Bieber L, Collister D, Whitlock R, Tangri N, Bohm C. Effect of Aerobic Exercise on Dialysis-Related Symptoms in Individuals Undergoing Maintenance Hemodialysis: A Systematic Review and Meta-Analysis of Clinical Trials. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):560-574. doi: 10.2215/CJN.15080920. Epub 2021 Mar 25.

  PMID: 33766925 BACKGROUND

• Hammerfald K, Eberle C, Grau M, Kinsperger A, Zimmermann A, Ehlert U, Gaab J. Persistent effects of cognitive-behavioral stress management on cortisol responses to acute stress in healthy subjects--a randomized controlled trial. Psychoneuroendocrinology. 2006 Apr;31(3):333-9. doi: 10.1016/j.psyneuen.2005.08.007. Epub 2005 Sep 23.

  PMID: 16183205 BACKGROUND

• Frisch JU, Hausser JA, Mojzisch A. The Trier Social Stress Test as a paradigm to study how people respond to threat in social interactions. Front Psychol. 2015 Feb 2;6:14. doi: 10.3389/fpsyg.2015.00014. eCollection 2015.

  PMID: 25698987 BACKGROUND

• Flythe JE, Hilliard T, Castillo G, Ikeler K, Orazi J, Abdel-Rahman E, Pai AB, Rivara MB, St Peter WL, Weisbord SD, Wilkie C, Mehrotra R. Symptom Prioritization among Adults Receiving In-Center Hemodialysis: A Mixed Methods Study. Clin J Am Soc Nephrol. 2018 May 7;13(5):735-745. doi: 10.2215/CJN.10850917. Epub 2018 Mar 20.

  PMID: 29559445 BACKGROUND

• Fujiwara K, Asai H, Toyama H, Kunita K, Yaguchi C, Kiyota N, Tomita H, Jacobs JV. Changes in muscle thickness of gastrocnemius and soleus associated with age and sex. Aging Clin Exp Res. 2010 Feb;22(1):24-30. doi: 10.1007/BF03324811. Epub 2009 Nov 6.

  PMID: 19920407 BACKGROUND

• Dickmeis T. Glucocorticoids and the circadian clock. J Endocrinol. 2009 Jan;200(1):3-22. doi: 10.1677/JOE-08-0415. Epub 2008 Oct 29.

  PMID: 18971218 BACKGROUND

• Bruck K, Stel VS, Gambaro G, Hallan S, Volzke H, Arnlov J, Kastarinen M, Guessous I, Vinhas J, Stengel B, Brenner H, Chudek J, Romundstad S, Tomson C, Gonzalez AO, Bello AK, Ferrieres J, Palmieri L, Browne G, Capuano V, Van Biesen W, Zoccali C, Gansevoort R, Navis G, Rothenbacher D, Ferraro PM, Nitsch D, Wanner C, Jager KJ; European CKD Burden Consortium. CKD Prevalence Varies across the European General Population. J Am Soc Nephrol. 2016 Jul;27(7):2135-47. doi: 10.1681/ASN.2015050542. Epub 2015 Dec 23.

  PMID: 26701975 BACKGROUND

• Blair J, Adaway J, Keevil B, Ross R. Salivary cortisol and cortisone in the clinical setting. Curr Opin Endocrinol Diabetes Obes. 2017 Jun;24(3):161-168. doi: 10.1097/MED.0000000000000328.

  PMID: 28375882 BACKGROUND

• Atkinson AJ Jr. Elucidation of the pathophysiology of intradialytic muscle cramps: pharmacokinetics applied to translational research. Transl Clin Pharmacol. 2019 Dec;27(4):119-122. doi: 10.12793/tcp.2019.27.4.119. Epub 2019 Dec 31.

  PMID: 32095478 BACKGROUND

• Alghadir AH, Anwer S, Zafar H, Iqbal ZA. Effect of localised vibration on muscle strength in healthy adults: a systematic review. Physiotherapy. 2018 Mar;104(1):18-24. doi: 10.1016/j.physio.2017.06.006. Epub 2017 Aug 6.

  PMID: 28947078 BACKGROUND

• Ahsan M, Gupta M, Omar I, Frinak S, Gendjar S, Osman-Malik Y, Yee J. Prevention of hemodialysis-related muscle cramps by intradialytic use of sequential compression devices: a report of four cases. Hemodial Int. 2004 Jul 1;8(3):283-6. doi: 10.1111/j.1492-7535.2004.01106.x.

  PMID: 19379428 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ayşe Özkaraman, Professor

  Eskisehir Osmangazi University Faculty of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Nurse

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 6, 2025
• Study Start: November 21, 2025
• Primary Completion: February 21, 2026
• Study Completion: February 21, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: July - December 2025
• Access Criteria: Academic staff can request this information. Data can be shared with the permission of all researchers involved in the study.

Locations

TU (1)