HemodialysisNCT07181746
Effect of Exercises on Restless Leg Syndrome, Functional Capacity and Physical Self-perception Among Hemodialysis
A study testing leg exercises in people with Hemodialysis and Functional Capacities, run by Norther Private Collage of Nursing.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hemodialysis, Functional Capacities, Excercise
- What is being tested?
- leg exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 3 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Pilates Exercises on Restless Leg Syndrome, Functional Capacity and Physical Self-perception Among Older Adult Undergoing 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.
Read the detailed description
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.
- Conditions
- Hemodialysis, Functional Capacities, Excercise
- Being tested
- leg exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg exercisesProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | Pilates Exercises Receives: Procedure: leg exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion2 Oct 2025 (estimated)
- Study completion3 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group assignment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norther Private Collage of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Hashem, Norther Private Collage of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181746
- Sponsor's protocol ID
- amalhasem@nec.edu.sa
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises on Restless Leg Syndrome, Functional Capacity and Physical Self-perception Among Older Adult Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT07181746
- Acronym / sponsor ID
- amalhasem@nec.edu.sa
- Conditions
- Hemodialysis, Functional Capacities, Excercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Norther Private Collage of NursingUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 2 Oct 2025 (estimated)
- Study completion
- 3 May 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group assignment
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Procedure: leg exercisesPilates Exercises |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age of ≥ 65 years old,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leg exercisesThe 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 | Procedure or surgery | intervention group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing leg exercises in people with Hemodialysis and Functional Capacities, run by Norther Private Collage of Nursing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amal Mohamed, phd (0568637931, amalm53@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity level of restless leg syndrome (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.