Effects of Massage and Progressive Muscle Relaxation Exercise on the Severity and Frequency of Muscle Cramps in Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- pain report
研究概览
简要总结
Muscle cramps are a common and distressing issue among hemodialysis patients, significantly impacting their quality of life. Non-pharmacological approaches are increasingly being explored to alleviate these symptoms. Massage therapy and progressive muscle relaxation exercises are among the interventions that may help reduce the frequency and severity of cramps by promoting muscle relaxation. However, their effectiveness in hemodialysis patients has not been sufficiently studied.
This randomized controlled trial aims to evaluate the effects of massage and progressive muscle relaxation exercises on the frequency and severity of muscle cramps in hemodialysis patients. The findings are expected to contribute to evidence-based practices in symptom management.
详细描述
Method Study Design and Setting This study will be conducted using a quasi-experimental design to evaluate the effects of foot massage and progressive muscle relaxation exercises (PMRE) on muscle cramps in hemodialysis patients. The study will take place at the hemodialysis center of Istanbul Gaziosmanpasa Training and Research Hospital between February and August 2025.
Population and Sample The study population consists of all hemodialysis patients registered at the study center, while the sample will include voluntary hemodialysis patients with similar demographic characteristics and dialysis treatment methods who meet the study criteria. Since no identical study exists in the literature, a power analysis was conducted to determine the sample size required to show a significant difference in the reduction of the mean number of cramps (effect size = 1), with 80% power and a 5% Type I error rate. Accordingly, 30 patients per group (massage group, PMRE group, and control group), totaling 90 patients, were planned for inclusion in the study.
Inclusion criteria:
Aged 18 years and older Receiving chronic hemodialysis treatment Experiencing muscle cramps in the last three months No physical or mental health conditions preventing communication
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving Hemodialysis Treatment: Patients who have been undergoing regular hemodialysis treatment for at least six months.
- •History of Muscle Cramps: Patients who have experienced muscle cramps at least twice a week in the past month.
- •Age Range: Between 18 and 75 years old. Must be able to swallow tablets Cognitive and Physical Suitability: Having the cognitive and physical capacity to understand and perform massage and progressive muscle relaxation exercises.
- •Stable Cardiovascular Condition: No history of myocardial infarction or severe cardiovascular complications in the past three months.
- •Stable Medical Condition: No acute or severe medical conditions other than dialysis treatment.
- •Voluntary Participation: Signing the informed consent form after being fully informed about the study.
排除标准
- •Insulin dependent diabetes Thyroid disease Clinical diagnosis of Alzheimer's Disease
- •Neuromuscular Disorders: Presence of conditions such as multiple sclerosis, Parkinson's disease, or peripheral neuropathy.
- •Severe Cardiovascular Diseases: History of myocardial infarction, congestive heart failure (NYHA class III-IV), or uncontrolled hypertension in the past three months.
- •Severe Orthopedic or Rheumatic Conditions: Severe osteoarthritis, rheumatoid arthritis, or other chronic musculoskeletal disorders.
- •Acute Infections or Inflammatory Conditions: Diagnosis of an active infection or inflammatory disease during the study period.
- •Mental or Psychiatric Disorders: Presence of severe cognitive impairment, dementia, or major depression/anxiety.
- •End-Stage Cancer Diagnosis: Undergoing active cancer treatment or having metastatic cancer.
- •Contraindications to Massage or Relaxation Exercises: Presence of skin infections, open wounds, or any medical condition preventing massage or exercise application.
- •Regular Use of Alternative Therapies: Engaging in regular massage therapy, yoga, or similar relaxation techniques within the past three months.
- •Pregnancy: Being pregnant or in the breastfeeding period. Inability to Comply with the Study: Difficulty in attending the study regularly or adhering to the assigned interventions.
研究组 & 干预措施
stretching exercise group
stretching exercise group
干预措施: relaxation group (Behavioral)
foot massage
foot massage group
干预措施: massage (Behavioral)
control group
control group
结局指标
主要结局
pain report
时间窗: 3 months
pain measurement scale report
次要结局
未报告次要终点
研究者
Gürcan Solmaz
PhD
University of Yalova