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Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps

Primary Purpose

Muscle Cramp

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Intradialytic stretching exercises
Sponsored by
Kufa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Cramp focused on measuring Stretching Exercises, Muscle Cramps, Hemodialysis.

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with age group 20-60 years, because it is the most common age group affected by CKD and they appropriate to apply for the study program.
  • Both male and female patients who are undergoing hemodialysis and suffer from muscle cramps.
  • Patients who are receiving two or more HD sessions a week, to facilitate patients follow-up.
  • Patients who are willing to participate, because the patients' participation is voluntary.
  • Patients who are alert and able to communicate verbally, to make the program applicable and facilitate the data collection.

Exclusion Criteria:

  • Emergency hemodialysis patients, to avoid mal-efficient (harmlessly apply the program).
  • Patients with vascular access in a lower extremity, to avoid vascular access failure.
  • Patients with skin sores, wounds, dermatitis, or edema of the lower extremities, with a known history of deep vein thrombosis (DVT), peripheral vascular disease (PVD), or peripheral neuropathy, to prevent complications.
  • Patients who are unable to communicate, because the patients' communication is an essential part of data collection.
  • Patients who suffer from breathing difficulty, because the application of the program required patients compliance and may cause fatigue among involved patients
  • Not willing to participate, because the patients' participation is voluntary.

Sites / Locations

  • Al-Sadder Medical City / The Specialized Center for Kidney Diseases and Transplantation / Hemodialysis Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

The intervention in this group is stretching exercises with the aim of prevention and reduction of leg muscle cramps among patients undergoing hemodialysis

The participants in this group used as reference group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2021
Last Updated
May 25, 2021
Sponsor
Kufa University
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1. Study Identification

Unique Protocol Identification Number
NCT04901832
Brief Title
Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps
Official Title
Effectiveness of Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps Among Patients Undergoing Hemodialysis: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 13, 2020 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
March 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kufa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Cramp
Keywords
Stretching Exercises, Muscle Cramps, Hemodialysis.

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The intervention in this group is stretching exercises with the aim of prevention and reduction of leg muscle cramps among patients undergoing hemodialysis
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The participants in this group used as reference group
Intervention Type
Other
Intervention Name(s)
Intradialytic stretching exercises
Intervention Description
Exercises performed actively and passively to reduce or prevent muscle cramps during hemodialysis procedure.
Primary Outcome Measure Information:
Title
Muscle cramp questionnaire chart
Description
The muscle cramp questionnaire chart is adopted to assess the level of muscle cramps during hemodialysis, before and after the intervention.
Time Frame
4 week muscle cramp assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with age group 20-60 years, because it is the most common age group affected by CKD and they appropriate to apply for the study program. Both male and female patients who are undergoing hemodialysis and suffer from muscle cramps. Patients who are receiving two or more HD sessions a week, to facilitate patients follow-up. Patients who are willing to participate, because the patients' participation is voluntary. Patients who are alert and able to communicate verbally, to make the program applicable and facilitate the data collection. Exclusion Criteria: Emergency hemodialysis patients, to avoid mal-efficient (harmlessly apply the program). Patients with vascular access in a lower extremity, to avoid vascular access failure. Patients with skin sores, wounds, dermatitis, or edema of the lower extremities, with a known history of deep vein thrombosis (DVT), peripheral vascular disease (PVD), or peripheral neuropathy, to prevent complications. Patients who are unable to communicate, because the patients' communication is an essential part of data collection. Patients who suffer from breathing difficulty, because the application of the program required patients compliance and may cause fatigue among involved patients Not willing to participate, because the patients' participation is voluntary.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diaa K Abd-Ali, Dr.
Organizational Affiliation
University of Al-Ameed. College of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Al-Sadder Medical City / The Specialized Center for Kidney Diseases and Transplantation / Hemodialysis Unit
City
Kufa
State/Province
Al Najaf
ZIP/Postal Code
54003
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Any data that does not violate ethical considerations will be obtained from the researcher.
IPD Sharing Time Frame
Starting in October 2021
IPD Sharing Access Criteria
Researchers in medical colleges (bachelors, masters, and doctorates), the Iraqi Ministry of Higher Education and Research, and the Iraqi Ministry of Health can access the data by emailing the researcher.

Learn more about this trial

Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps

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