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Not Yet RecruitingNCT07293182

Legs Exercises and Compression Stockings for Prevention of Hemodialysis Muscle Cramps

Effect of Legs Exercises and Compression Stockings in the Prevention of Muscle Cramps Among Hemodialysis Patients

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
108 (estimated)
Sponsor
Karbala University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

the Objectives of this clinical trial is : 1. Investigate the effect of legs exercises in the prevention of muscle cramps among hemodialysis patients. 2. Examine the effect of compression stockings in the prevention of muscle cramps among hemodialysis patients. 3. Compare between effect of legs exercises and compression stockings in the prevention of muscle cramps among hemodialysis patients. 4. Find out the relationship between the effect of legs exercises and compression stockings in the prevention of muscle cramps with patients' demographic and clinical data.

Detailed description

In 2023, Iraq recorded an end-stage renal disease prevalence rate of 235.6 per million, reflecting a significant increase from 2011 to 2023 . Hemodialysis (HD) is the most widely used treatment for patients with end-stage renal disease worldwide, accounting for approximately 89% of all dialysis treatments. However, HD is associated with various side effects that stem from both the dialysis procedure and the progression of the underlying disease. Among these, patients often experience muscle cramps, which manifest as severe, painful contractions affecting either a single muscle or a group of muscles . Factors triggering these cramps include electrolyte imbalances, ischemia, carnitine depletion, tissue hypoxia, hyponatremia, hypomagnesemia, fluctuations in plasma concentration, and elevated serum leptin levels . Muscle cramps negatively impact sleep and the quality of life for patients; in extreme cases, they may lead patients to consider discontinuing dialysis treatment . Additionally, shortened dialysis sessions can increase hospital admissions and the risk of mortality among dialysis patients by 13% to 30% . Most methods for relieving muscle cramp pain have been pharmacological; however, these often elevate the risk of drug toxicity since the kidneys primarily excrete the metabolites of these drugs. This study investigates the effects of leg exercises and compression stockings on the prevention of leg cramps. These intervention methods have been less commonly utilized and have predominantly been explored in small patient populations. this research will provide insights into the effectiveness of these approaches and contribute to the development of improved prevention strategies. When a dialysis patient exercises, the leg muscles signal the brain to increase blood flow to provide the necessary energy for activity . Exercise during dialysis positively impacts urea clearance by enhancing tissue exposure and opening blood vessels in the working muscles, allowing fluids within the tissues to flow into the intravascular space. Furthermore, ions such as potassium and phosphate move from the intracellular space into the muscle interstitial fluid during exercise, improving blood flow to the muscles and alleviating pain in these patients . The use of graduated compression stockings applies a pressure gradient that ensures blood flows upward toward the heart rather than backing up toward the feet or sideways into the superficial veins. This application of an appropriate pressure gradient reduces the diameter of major veins, increasing the velocity and volume of blood flow. Gradient compression can effectively reverse elevated venous blood pressure, enhance skeletal muscle pumping, facilitate venous return, and improve lymphatic drainage.

Conditions

Interventions

TypeNameDescription
DEVICElegs exercisesparticipants in the Legs Exercises Group were trained to use a mini stationary bike in a supine position for 30 minute from the end of the second hour to the beginning of the third hour of hemodialysis session once per session and the same was repeated for 3 such session . The exercise was performed under the supervision of a trained nurse.
DEVICEcompression stockingsParticipants in the Compression Stockings Group: apply Compression stockings for 30 minutes from the end of the second hour to the beginning of the third hour of hemodialysis session once per session and the same was repeated for 3 such session .

Timeline

Start date
2025-12-25
Primary completion
2026-03-25
Completion
2026-06-20
First posted
2025-12-19
Last updated
2025-12-19

Source: ClinicalTrials.gov record NCT07293182. Inclusion in this directory is not an endorsement.