Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps
Condition: Muscle Cramp
MeSH terms: Muscle Cramp; Spasm
Study type: Interventional

Summary: 
      Renal replacement therapy is a treatment option for people who have acute or chronic renal
      failure. A patient with increasing symptoms of renal failure is referred to a dialysis and
      transplantation center early in the course of progressive kidney disease. Hemodialysis is one
      of the most widely used dialysis procedures. Muscle cramps are the most common complication
      experienced by hemodialysis patients that usually develop during and in between hemodialysis
      therapy. These cramps appear to be the most common reason for the early termination of the
      hemodialysis session.

      - Research Question: Is there a difference in leg muscle cramps levels between patients
      undergoing hemodialysis who received intradialytic stretching exercises compared to those
      patients who do not receive these exercises?

      - Hypothesis: Leg muscle cramp levels are less among patients undergoing hemodialysis who
      receive intradialytic stretching exercises compared to those patients who do not receive such
      exercises.
    

Detailed description: 
      Study Sample:

      Non-probability purposive sample of 60 patients undergoing hemodialysis. The sample is
      divided randomly into two groups; 30 patients as study group are exposed to intradialytic
      stretching exercises, and the other 30 patients are not exposed to the exercises considered
      as the control group.

      The Study Instrument:

      To determine the effectiveness of the intradialytic stretching exercises program on the
      prevention and reduction of leg muscle cramps among patients undergoing hemodialysis, the
      researcher has adopted an assessment tool in order to achieve each of the study objectives.
      This tool consists of three parts:

      Part I: Socio-Demographic Data:

      A socio-demographic datasheet consists of (6) items, which include residency, gender, age,
      smoking, educational level, occupational status. These variables are coded as preparation for
      data analysis.

      Part II: Clinical Variable:

      The second part of the questionnaire consists of (10) items, which include duration of
      dialysis treatment, number of hemodialysis session per week, duration of hemodialysis
      session, frequency of leg muscle cramps per week, site of leg muscle cramps, comorbidity,
      level of calcium, body mass index, ultrafiltration rate, and ultrafiltration volume. These
      variables are coded as preparation for data analysis.

      Part III: Muscle Cramp questionnaire chart. The muscle cramp questionnaire chart is adopted
      to assess the level of muscle cramps during hemodialysis, before and after the intervention.
      This chart is used because it is an easy and valid tool, as it has been adopted in several
      previous studies. It contains various features of muscle cramps such as the frequency of
      muscle cramps, duration of muscle cramps, level of pain, temperature, and discomfort which
      was comprehensively scored as the level of muscle cramps ranging from (0-13).

      Score Interpretation of Study Instruments :

      Four scores are used for rating the levels of leg muscle cramps among Patients undergoing
      Hemodialysis in terms of no cramps, mild cramps, moderate cramps, and severe cramps. These
      cramps levels are scored as (0) for no cramps, (1 - 4) for Mild cramps, (5 - 8) for moderate
      cramps, and (9 - 13) for severe cramps.

      Regarding the body mass index, four scores are used for rating the body mass index categories
      in terms of underweight, normal, overweight, obesity. These categories are scored as shown in
      the following table from Centers for Disease Control and Prevention, (2020) Underweight:Below
      18.5 Normal or Healthy Weight:18.5 - 24.9 Overweight:25.0 - 29.9 Obese:30.0 and Above

      Data collection The Data Collection was done according to CONSORT 2010 Flow Diagram
    

Intervention name(s): Intradialytic stretching exercises
Intervention type(s): Other
Intervention description(s): Exercises performed actively and passively to reduce or prevent muscle cramps during hemodialysis procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Stretching Exercises, Muscle Cramps, Hemodialysis.