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

NCT07181746 | Not Yet Recruiting

• 1 other identifier: amalhasem@nec.edu.sa
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hemodialysis; Functional Capacities; Excercise

Outcome Measures

Primary Outcomes (1)

• change in severity level of restless leg syndrome

  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

  3 month

Study Arms (1)

intervention group

ACTIVE COMPARATOR

Pilates Exercises

Procedure: leg exercises

Interventions

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

intervention group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Norther Private Collage of Nursing: lead

Central Study Contacts

Amal Mohamed, phd

CONTACT

0568637931; amalm53@yahoo.com

Amal Hashem Associate, phd

CONTACT

0568637931; amalm53@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Non
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: single group assignment

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion: October 2, 2025
• Study Completion: May 3, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share