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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorNorther Private Collage of Nursing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • leg exercises

    Procedure/Surgery

    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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: intervention groupActive comparator 1 intervention

Trial outcomes

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

Time frame
3 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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