Muscle CrampNCT04901832
Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps
A study testing Intradialytic stretching exercises in people with Muscle Cramp, run by Kufa University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Muscle Cramp
- What is being tested?
- Intradialytic stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 13 Dec 2020to 22 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Al-Sadder Medical City / The Specialized Center for Kidney Diseases and Transplantation / Hemodialysis Unit
Kufa, Al Najaf, 54003
About this study
Official title: Effectiveness of Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps Among Patients Undergoing Hemodialysis: Randomized Controlled Trial
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.
Read the 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
- Conditions
- Muscle Cramp
- Being tested
- Intradialytic stretching exercises
- Keywords
- Stretching Exercises, Muscle Cramps, Hemodialysis.
- Medical subject headings
- Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic stretching exercisesOther
Exercises performed actively and passively to reduce or prevent muscle cramps during hemodialysis procedure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The intervention in this group is stretching exercises with the aim of prevention and reduction of leg muscle cramps among patients undergoing hemodialysis Receives: Other: Intradialytic stretching exercises |
| Control Group | No intervention | The participants in this group used as reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 week muscle cramp assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start13 Dec 2020
- Primary completion13 Jan 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle CrampStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kufa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amjed Abdulabbas Shraida, Kufa University
- Investigators
- Diaa K Abd-Ali, Dr., Study director, University of Al-Ameed. College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901832
- Sponsor's protocol ID
- IDSE-1
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any data that does not violate ethical considerations will be obtained from the researcher.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps Among Patients Undergoing Hemodialysis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04901832
- Acronym / sponsor ID
- IDSE-1
- Conditions
- Muscle Cramp
- Keywords
- Stretching Exercises, Muscle Cramps, Hemodialysis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kufa UniversityUniversity, hospital or other
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Intradialytic stretching exercisesThe intervention in this group is stretching exercises with the aim of prevention and reduction of leg muscle cramps among patients undergoing hemodialysis |
| Control Group | No intervention | –The participants in this group used as reference group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradialytic stretching exercisesExercises performed actively and passively to reduce or prevent muscle cramps during hemodialysis procedure. | Other | Experimental Group |
Primary outcome
Muscle cramp questionnaire chart
Time frame: 4 week muscle cramp assessment
The muscle cramp questionnaire chart is adopted to assess the level of muscle cramps during hemodialysis, before and after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: Yes. Any data that does not violate ethical considerations will be obtained from the researcher.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diaa K Abd-Ali, Dr. study director
University of Al-Ameed. College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic stretching exercises in people with Muscle Cramp, run by Kufa University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle cramp questionnaire chart (time frame: 4 week muscle cramp assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.