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临床试验/NCT06759376
NCT06759376已完成不适用

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

Figen Akay1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
intradialytic muscle cramp (severity)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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].

排除标准

  • 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.

研究组 & 干预措施

Stretching (Group B)

Experimental

Static stretching exercise

干预措施: Static stretching exercise (Other)

Vibration (Group A)

Experimental

Vibration massage

干预措施: Vibration massage (Other)

Control (Group C)

Other

Usual care

干预措施: Usual Care (Other)

结局指标

主要结局

intradialytic muscle cramp (severity)

时间窗: 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

时间窗: 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)

时间窗: 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.

intradialytic muscle cramp (severity)

时间窗: 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

时间窗: 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)

时间窗: 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.

次要结局

  • Acute stress(1 year)
  • Heart rate(1 years)
  • Systolic and Diastolic Blood Pressure(1 years)
  • Acute stress(1 year)

研究者

发起方
Figen Akay
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Figen Akay

Specialist Nurse

Eskisehir Osmangazi University

研究点 (1)

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