HemodialysisNCT06445647
Effect of Core Exercise on ADL in Hemodialysis
A study testing core Stability exercise and Breathing exercises in people with Hemodialysis, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Finding the effect of core stability exercises with breathing exercises on Activities of daily living (ADLs), fatigue level and balance in maintenance hemodialysis patients. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- core Stability exercise and Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2024to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ranging from 55- 70 years old of both genders.
- Diagnosed as maintenance hemodialysis for at least 6 months or more.
- Free from mental illness, neuromuscular disorders, and serious lung problems and able to implement the interventional exercise.
Who cannot join
- Obesity (BMI ≥ 30 kg/m2)
- Orthopeadics or neurological problems that interferes with training.
- History of pulmonary problems (COPD, pneumonia)
- History of Myocardial infarction and/or cardiothoracic surgery
- Unstable medical status
- Dementia that interferes with the ability to follow instructions.
- History Chronic Fatigue Syndrome (CFS).
Trial locations and contacts
1 site in 1 country.
Mohammed S Saif, Ph.D contact
About this study
Official title: Effect of Core Stability Exercise Training on Activities of Daily Living, Fatigue Level and Balance in Hemodialysis
Finding the effect of core stability exercises with breathing exercises on Activities of daily living (ADLs), fatigue level and balance in maintenance hemodialysis patients.
Read the detailed description
Sixty patients will be randomly assigned into two equal groups, the experimental (EX) group and the control group (CON). The participants' age will be 50-65 years and undergo hemodialysis. The Ex-group will attend three sessions/week of core stability exercise training (CSE) combined with Deep Breathing (25:30-min) for 8 weeks, the CON will attend 3 sessions/week of Deep Breathing (15-min) for 8 weeks. All the patients received only routine hemodialysis department care.
- Conditions
- Hemodialysis
- Being tested
- core Stability exercise, Breathing exercises
- Keywords
- Core Exercise, ADL, Balance, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core Stability exerciseOther
core stability exercise training
Breathing exercisesOther
Deep breathing and diaphragmatic breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | 30 hemodialysis patient Receives: Other: core Stability exercise; Other: Breathing exercises |
| Control group | Active comparator | 30 hemodialysis patient Receives: Other: Breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of Daily Livings (ADLs)
ADLs will be assessed by Barthel Index (BI)
Measured: up to 8 weeks
Fatigue
Fatigue will be assessed by fatigue assessment scale. The total score ranges from 10 to 50. A total score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Measured: up to 8 weeks
Balance
Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score < 10 seconds = normal < 20 seconds = good mobility; can walk outside alone; does not require a walking aid < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start30 Jun 2024
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Nov 2025 (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.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Youssef Elhamrawy, Beni-Suef University
- Investigators
- Mohammed S Saif, Principal investigator, National institute for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445647
- Sponsor's protocol ID
- core exercise
- Status last verified
- Jul 2024
- First submitted
- 30 May 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Exercise Training on Activities of Daily Living, Fatigue Level and Balance in Hemodialysis
- ClinicalTrials.gov ID
- NCT06445647
- Acronym / sponsor ID
- core exercise
- Conditions
- Hemodialysis
- Keywords
- Core Exercise, ADL, Balance, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 6 Jun 2024 (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.
Finding the effect of core stability exercises with breathing exercises on Activities of daily living (ADLs), fatigue level and balance in maintenance hemodialysis patients.
Detailed description
Sixty patients will be randomly assigned into two equal groups, the experimental (EX) group and the control group (CON). The participants' age will be 50-65 years and undergo hemodialysis. The Ex-group will attend three sessions/week of core stability exercise training (CSE) combined with Deep Breathing (25:30-min) for 8 weeks, the CON will attend 3 sessions/week of Deep Breathing (15-min) for 8 weeks. All the patients received only routine hemodialysis department care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Other: core Stability exercise, Other: Breathing exercises30 hemodialysis patient |
| Control group | Active comparator | Other: Breathing exercises30 hemodialysis patient |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ranging from 55- 70 years old of both genders.
- Diagnosed as maintenance hemodialysis for at least 6 months or more.
- Free from mental illness, neuromuscular disorders, and serious lung problems and able to implement the interventional exercise.
Key exclusion criteria (7 listed)
- Obesity (BMI ≥ 30 kg/m2)
- Orthopeadics or neurological problems that interferes with training.
- History of pulmonary problems (COPD, pneumonia)
- History of Myocardial infarction and/or cardiothoracic surgery
- Unstable medical status
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 |
|---|---|---|
| core Stability exercisecore stability exercise training | Other | Study Group |
| Breathing exercisesDeep breathing and diaphragmatic breathing exercises | Other | Control group, Study Group |
Primary outcome
Activities of Daily Livings (ADLs)
Time frame: up to 8 weeks
ADLs will be assessed by Barthel Index (BI)
Fatigue
Time frame: up to 8 weeks
Fatigue will be assessed by fatigue assessment scale. The total score ranges from 10 to 50. A total score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Balance
Time frame: up to 8 weeks
Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score < 10 seconds = normal < 20 seconds = good mobility; can walk outside alone; does not require a walking aid < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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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. This study is not recruiting at the moment.
Mohammed S Saif, Ph.D contact
Mohammed S Saif principal investigator
National institute for Gerontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core Stability exercise and Breathing exercises in people with Hemodialysis, run by Beni-Suef University at 1 site in Egypt.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Yo Elhamrawy, Ph.D (+201282805567, dr_melhamrawy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of Daily Livings (ADLs) (time frame: up to 8 weeks). The study lists 3 primary outcomes in all. 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 2 May 2025.