Effect of Nurse-Led Intradialytic Stretching Exercises on Muscle Cramp Burden Among Patients Undergoing Maintenance Hemodialysis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Post-intervention muscle cramp intensity category
研究概览
简要总结
This single-center, parallel-group randomized controlled trial aims to evaluate the effect of a nurse-led intradialytic stretching program on the burden of muscle cramps in patients receiving maintenance hemodialysis (HD). Sixty adult patients on thrice-weekly HD with a history of lower-limb cramps will be randomized 1:1 to either an intervention group or a usual care control group.
The intervention consists of a standardized protocol of supervised lower-limb stretches (ankle dorsiflexion, gastrocnemius, soleus, and hamstring stretches). Each stretch will be held for 20-30 seconds and repeated three times per limb. The protocol will be delivered by HD nurses during dialysis sessions, twice a week for a total of 15 sessions over approximately eight weeks. Fidelity will be monitored using a structured checklist. The control group will receive routine care without structured exercises.
The primary outcome is the post-intervention cramp intensity category, measured using the Arabic Muscle Cramp Severity and Characteristics Questionnaire (MC-SCQ). Secondary outcomes include cramp frequency, duration, pain intensity, leg temperature perception, and discomfort/functional interference.
详细描述
- The Problem: The Burden of Intradialytic Muscle Cramps For patients undergoing maintenance hemodialysis (HD), the treatment is a life-sustaining necessity that comes with a significant symptom burden. Among the most common and disruptive of these symptoms are intradialytic muscle cramps-sudden, involuntary, and painful muscle contractions, primarily in the lower limbs. These episodes are not merely a minor inconvenience; they represent a serious clinical challenge. Cramps can be severe enough to forcibly halt a dialysis session, trigger distress calls to nurses, and necessitate urgent interventions such as sterile saline boluses or adjustments to the ultrafiltration rate. These reactive measures disrupt the dialysis process, can lead to hemodynamic instability, and increase nursing workload. For the patient, the experience is one of pain, anxiety, and a diminished quality of life. Estimates suggest these cramps affect a wide proportion, between 20% to 85%, of the chronic HD population.
- The Proposed Solution: A Proactive, Nurse-Led Intervention Traditional management of these cramps has largely been reactionary. This study proposes to test a paradigm shift: moving from reactive treatment to proactive, nurse-led prevention. The intervention under investigation is a standardized protocol of lower-limb stretching exercises, administered during the dialysis session (intradialytically). The rationale is grounded in exercise physiology: sustained stretching is believed to improve muscle flexibility, enhance local circulation, and modulate neuromuscular excitability, potentially raising the threshold at which a cramp is triggered. By leveraging the time patients are already connected to the dialysis machine and the constant presence of a nurse, this strategy offers a low-cost, non-pharmacological, and patient-centric approach that aligns with nursing values of health promotion and continuity of care.
- Study Design and Rigor
To generate high-quality evidence, this study employs a single-center, parallel-group, randomized controlled trial (RCT) design. In this design, 60 eligible adult patients from the Beni-Suef University Hospital HD unit will be randomly assigned to one of two groups:
The Intervention Group: Will receive the nurse-led intradialytic stretching program in addition to usual care.
The Control Group: Will continue to receive usual care without any structured exercise program.
This randomization process is intended to ensure that the groups are similar in all key aspects at the beginning of the study. To safeguard the integrity of the intervention, the research team will use a fidelity checklist to ensure every stretching session is delivered consistently and correctly. 4. The Intervention in Detail The stretching protocol is designed to be both effective and feasible within a busy dialysis unit. It targets the primary muscle groups involved in cramps: the ankle dorsiflexors, gastrocnemius, soleus, and hamstrings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 21 years or older.
- •Undergoing maintenance hemodialysis on a thrice-weekly schedule.
- •Have been on hemodialysis for at least 3 months.
- •Clinically stable.
- •Have a history of intradialytic lower-limb muscle cramps in the preceding month.
- •Able to provide informed consent.
排除标准
- •Musculoskeletal or neurological disorders that limit safe lower-limb stretching.
- •Femoral vascular access or recent lower-limb vascular procedures.
- •Undergoing their first or an emergency hemodialysis session.
- •Inability to provide informed consent.
研究组 & 干预措施
The intervention group (nurse-led intradialytic stretching exercises)
This arm received a structured, nurse-led lower-limb stretching program in addition to their usual hemodialysis (HD) care. The intervention was designed to be a proactive, non-pharmacological strategy to prevent intradialytic muscle cramps.
干预措施: Nurse-Led Intradialytic Stretching Exercises (Other)
The control group (usual care)
This control arm received routine hemodialysis care without any structured exercise program.
结局指标
主要结局
Post-intervention muscle cramp intensity category
时间窗: 8 weeks
Post-intervention muscle cramp intensity category, as measured by the Arabic Muscle Cramp Severity and Characteristics Questionnaire (MC-SCQ). The total MC-SCQ score (range 0-13) was mapped into a four-level ordinal categorical variable: None (0), Mild (1-4), Moderate (5-8), or Severe (9-13). The distribution of participants across these categories was compared between the study and control groups at the end of the 8-week intervention period.
次要结局
未报告次要终点
研究者
Ahmed Mostafa Shehata
Lecturer of Medical Surgical Nursing, faculty of Nursing, Beni-Suef University
Beni-Suef University
