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NOT YET RECRUITING
NCT06759376
NA

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

Sponsor: Figen Akay

View on ClinicalTrials.gov

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.

Official title: Effects of Vibration Massage and Static Stretching Exercise on Intradialytic Muscle Cramp and Salivary Cortisol Levels: A Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-26

Completion Date

2026-07-31

Last Updated

2025-10-01

Healthy Volunteers

No

Interventions

OTHER

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

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

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.

Locations (1)

Private Anatolian Dialysis Center

Eskişehir, Turkiye, Turkey (Türkiye)