Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps

NCT04901832 | Completed

• 1 other identifier: IDSE-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Cramp

Keywords

Stretching Exercises, Muscle Cramps, Hemodialysis.

Outcome Measures

Primary Outcomes (1)

• 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.

  4 week muscle cramp assessment

Study Arms (2)

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

Other: Intradialytic stretching exercises

Control Group

NO INTERVENTION

The participants in this group used as reference group

Interventions

Intradialytic stretching exercises OTHER

Exercises performed actively and passively to reduce or prevent muscle cramps during hemodialysis procedure.

Experimental Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kufa University: lead

Study Sites (1)

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

Kufa, Al Najaf, 54003, Iraq

Location

MeSH Terms

Conditions

Muscle Cramp

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diaa K Abd-Ali, Dr.

  University of Al-Ameed. College of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 26, 2021
• Study Start: December 13, 2020
• Primary Completion: January 13, 2021
• Study Completion: March 22, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting in October 2021
• 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.

Locations

IR (1)