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NCT Number: NCT07181746

Effect of Exercises on Restless Leg Syndrome, Functional Capacity and Physical Self-perception Among Hemodialysis

The study aimed to evaluate the effect of Pilates exercises on restless leg syndrome, functional capacity and physical self-perception among older adult undergoing hemodialysis. participants are 60 elderly patients both male and female who undergoing maintenance hemodialysis.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The research hypothesis include : H1: Older Adult Undergoing Hemodialysis who will practice Pilates exercises will have less severity of the Restless Leg Syndrome, and high Functional Capacity and Physical Self-Perception than those who will not practice.

Participants were divided into two groups (study and control). Both groups were asked to fill out all questionnaires before and after the study using the same tools. In the control group, older adult receives routine care, which was provided by the hospital as examination, routine medication . Participants were asked to answer a post-test using the same pre-test questionnaires. And the study group were divided into small training groups with 3-5 older adult for each group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Age of ≥ 65 years old,
  • A History of hemodialysis treatment two to three times per week for at least six months,
  • Interest in participation,
  • Being able to move independently and with a physical condition certified by a physician to play the sport, with no myocardial infarction or surgery in the past six months of the study.

Exclusion criteria

  • Three or more absences in exercise sessions;
  • Being a habitual Pilates practitioner;
  • Detection of reduced exercise tolerance, including tachycardia, shortness of breath, and feeling too tired or weak;
  • Peritoneal dialysis during the study; and other concurrent clinical conditions, such as cardio-respiratory problems reported by physician and/or patients

Treatment and study plan

leg exercises

Procedure

The patient in study group will offer 72 planned sessions along 16-week period, each session consisted of 5 minutes walking as a warm-up, followed by 30 to 45 minutes of resistance exercises tolerated by the patient, time maintained until the end of the intervention. Each participant will receive about two to three, personal training session regarding the technique of resistance training until they are perfect in performing the exercises. Participants will receive a booklet with instructions on the Pilates training illustrated by colored pictures. The sessions during the staying the patient's in the hospital will be supervised by the researchers

Primary outcomes

  1. change in severity level of restless leg syndrome

    Time frame: 3 month

    Restless Leg Syndrome Rating Scale: used for assessing the severity restless legs syndrome (RLS). This tool composed of 10-item questionnaire asks respondents to use Likert-type ratings. Each question contains answers that score from 0 to 4 points, with 0 representing the absence of a problem and 4 representing a very severe problem. Total scores can range from 0 to 40. Questions can be divided into one of two categories: disorder symptoms (nature, intensity, and frequency) and their impact (sleep issues, disturbances in daily functioning, and resultant changes in mood). Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points

Study contacts

Contact information is provided by the study sponsor or research team.

Amal Hashem Associate, phd

CONTACT

[email protected]

0568637931

Amal Mohamed, phd

CONTACT

[email protected]

0568637931

Sponsors and collaborators

Lead sponsor

Norther Private Collage of Nursing

Other

Registry information

Official study title

Effect of Pilates Exercises on Restless Leg Syndrome, Functional Capacity and Physical Self-perception Among Older Adult Undergoing Hemodialysis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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