Intradialytic ExerciseNCT07176403
Effect of Intradialytic Exercise on Sleep, Depression and Anxiety in HD Patients
A study testing intradialytic exercise in people with Intradialytic Exercise, run by Alexandria University at 1 site in Egypt.
Trial summary
this study aims To assess the effect of intradialytic exercise program on sleep quality, depression and anxiety in HD Patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Exercise
- What is being tested?
- intradialytic exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 15 Nov 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESKD patients on maintenance hemodialysis for more than three months.
- Age more than 18 years.
Who cannot join
- Mentally or physically unfit patients or with severe psychiatric illness.
- Patients who receive any psychotropic medications.
- Patients with overt ischemic heart disease or cardiac decompensation.
- Anemic patients (Hb ≤ 8 mg/dl).
- Patients presented with severe bone pains or muscle weakness secondary to chronic kidney disease-mineral and bone disorder (CKD-MBD).
- Patients with advanced lower limbs joints disease.
- Lower limb amputation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Aexandria University
Alexandria, 21526
mohamed mamdouh elsayed, MD, 00201068055103, dr_mohamedmamdouh87@yahoo.com
About this study
Official title: Effect of Intradialytic Exercise Program on Sleep Quality, Depression and Anxiety in Hemodialysis Patients
this study aims To assess the effect of intradialytic exercise program on sleep quality, depression and anxiety in HD Patients.
Read the detailed description
Intradialytic exercise is a common recommendation given to encourage patients to be physically active. Previous studies have suggested that intradialytic exercise is effective in reducing fatigue severity, improving sleep quality, enhancing exercise tolerance, improving quality of life and even psychological status. Research also revealed that intradialytic exercise can increase the efficacy of dialysis, subsequently alleviating inflammation, improving nutrition and bone mineral density. Patients typically undergo two or three hemodialysis sessions a week, with each session lasting for approximately 4 hours. Since many patients maintain bed rest during HD sessions, intradialytic exercise can be a potentially useful approach to improve their health without consuming extra time during the interdialytic period.
- Conditions
- Intradialytic Exercise
- Being tested
- intradialytic exercise, control group
- Keywords
- Intradialytic exercise, sleep, depression, anxiety, hemodialysis
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradialytic exerciseOther
50 patients will undergo Exercise training program for twelve weeks during hemodialysis session.
- Type of exercise: aerobic exercise training sessions using a lower limb ergometer.
- Frequency: three times per week.
- Duration: thirty minutes per session.
control groupOther
50 patients will not perform exercise during hemodialysis session
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 50 patients will undergo Exercise training program for twelve weeks during hemodialysis session.
1. Type of exercise: aerobic exercise training sessions using a lower limb ergometer.
2. Frequency: three times per week.
3. Duration: thirty minutes per session. Receives: Other: intradialytic exercise |
| control group | Placebo comparator | 50 patients will not perform exercise during hemodialysis session Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in sleep quality
by using The Pittsburgh sleep Quality Index (PSQI).
Measured: 12 weeks
change in depression scale
by using Beck Depression inventory (BDI)
Measured: 12 weeks
change in anxiety level
by using The Beck Anxiety Inventory (BAI) scoring
Measured: 12 weeks
Secondary outcomes (2)
effect on dialysis adequacy
by assessing urea reduction ratio (URR)
Measured: 12 weeks
effect on lipid profile
by assessing triglycerides and cholesterol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Jul 2025
- Primary completion15 Oct 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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intradialytic ExerciseStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include seventy patients maintained on regular hemodialysis in Alexandria University Hospitals. Patients will be divided into two groups: Group (A): 50 patients will perform exercise during hemodialysis session. Group (B): 50 patients will not be assigned to any exercise program (as a control group).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Mohamed mamdouh Elsayed, MD, Principal investigator, Associate professorIman Ezzat Elgohary, MD, Principal investigator, professorMarwa Mohamed Hassan, MD, Study chair, professorHeba Essam Abou EL wafa, MD, Study chair, professorRaghda Ashraf AboTawila, MBBCh, Study chair, resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176403
- Sponsor's protocol ID
- exercise effect on HD patients
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jung TD, Park SH. Intradialytic exercise programs for hemodialysis patients. Chonnam Med J. 2011 Aug;47(2):61-5. doi: 10.4068/cmj.2011.47.2.61. Epub 2011 Aug 31.
PubMed 22111062Rajan EJ, Subramanian S. The effect of depression and anxiety on the performance status of end-stage renal disease patients undergoing hemodialysis. Saudi J Kidney Dis Transpl. 2016 Mar;27(2):331-4. doi: 10.4103/1319-2442.178555.
PubMed 26997387Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.
PubMed 26163057Gordon L, McGrowder DA, Pena YT, Cabrera E, Lawrence-Wright M. Effect of exercise therapy on lipid parameters in patients with end-stage renal disease on hemodialysis. J Lab Physicians. 2012 Jan;4(1):17-23. doi: 10.4103/0974-2727.98665.
PubMed 22923917
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intradialytic Exercise Program on Sleep Quality, Depression and Anxiety in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07176403
- Acronym / sponsor ID
- exercise effect on HD patients
- Conditions
- Intradialytic Exercise
- Keywords
- Intradialytic exercise, sleep, depression, anxiety, hemodialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 16 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.
this study aims To assess the effect of intradialytic exercise program on sleep quality, depression and anxiety in HD Patients.
Detailed description
Intradialytic exercise is a common recommendation given to encourage patients to be physically active. Previous studies have suggested that intradialytic exercise is effective in reducing fatigue severity, improving sleep quality, enhancing exercise tolerance, improving quality of life and even psychological status. Research also revealed that intradialytic exercise can increase the efficacy of dialysis, subsequently alleviating inflammation, improving nutrition and bone mineral density. Patients typically undergo two or three hemodialysis sessions a week, with each session lasting for approximately 4 hours. Since many patients maintain bed rest during HD sessions, intradialytic exercise can be a potentially useful approach to improve their health without consuming extra time during the interdialytic period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include seventy patients maintained on regular hemodialysis in Alexandria University Hospitals. Patients will be divided into two groups: Group (A): 50 patients will perform exercise during hemodialysis session. Group (B): 50 patients will not be assigned to any exercise program (as a control group).
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: intradialytic exercise50 patients will undergo Exercise training program for twelve weeks during hemodialysis session. 1. Type of exercise: aerobic exercise training sessions using a lower limb ergometer. 2. Frequency: three times per week. 3. Duration: thirty minutes per session. |
| control group | Placebo comparator | Other: control group50 patients will not perform exercise during hemodialysis session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ESKD patients on maintenance hemodialysis for more than three months.
- Age more than 18 years.
Key exclusion criteria (7 listed)
- Mentally or physically unfit patients or with severe psychiatric illness.
- Patients who receive any psychotropic medications.
- Patients with overt ischemic heart disease or cardiac decompensation.
- Anemic patients (Hb ≤ 8 mg/dl).
- Patients presented with severe bone pains or muscle weakness secondary to chronic kidney disease-mineral and bone disorder (CKD-MBD).
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 |
|---|---|---|
| intradialytic exercise50 patients will undergo Exercise training program for twelve weeks during hemodialysis session. 1. Type of exercise: aerobic exercise training sessions using a lower limb ergometer. 2. Frequency: three times per week. 3. Duration: thirty minutes per session. | Other | Exercise group |
| control group50 patients will not perform exercise during hemodialysis session | Other | control group |
Primary outcome
change in sleep quality
Time frame: 12 weeks
by using The Pittsburgh sleep Quality Index (PSQI).
change in depression scale
Time frame: 12 weeks
by using Beck Depression inventory (BDI)
change in anxiety level
Time frame: 12 weeks
by using The Beck Anxiety Inventory (BAI) scoring
2 secondary outcomes
effect on dialysis adequacy
Time frame: 12 weeks
effect on lipid profile
Time frame: 12 weeks
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 16 Sep 2025.
- Background: PubMed 22111062Jung TD, Park SH. Intradialytic exercise programs for hemodialysis patients. Chonnam Med J. 2011 Aug;47(2):61-5. doi: 10.4068/cmj.2011.47.2.61. Epub 2011 Aug 31.
- Background: PubMed 26997387Rajan EJ, Subramanian S. The effect of depression and anxiety on the performance status of end-stage renal disease patients undergoing hemodialysis. Saudi J Kidney Dis Transpl. 2016 Mar;27(2):331-4. doi: 10.4103/1319-2442.178555.
- Background: PubMed 26163057Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.
- Background: PubMed 22923917Gordon L, McGrowder DA, Pena YT, Cabrera E, Lawrence-Wright M. Effect of exercise therapy on lipid parameters in patients with end-stage renal disease on hemodialysis. J Lab Physicians. 2012 Jan;4(1):17-23. doi: 10.4103/0974-2727.98665.
- Individual participant dataSharing planned: Undecided
Related trials for Intradialytic Exercise
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Hemodialysis
Recruiting
Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD)
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Enrolling by invitation
The Effect of Intradialytic Eye Exercise in Hemodialysis Patients
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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.
Mohamed mamdouh Elsayed, MD principal investigator
Associate professor
Iman Ezzat Elgohary, MD principal investigator
professor
Marwa Mohamed Hassan, MD study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intradialytic exercise in people with Intradialytic Exercise, run by Alexandria 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 2 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: looking for participants now, as of the sponsor's last update on 16 Sep 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. Some participants in this study may receive a placebo. 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 Mohamed mamdouh Elsayed, MD (00201068055103, dr_mohamedmamdouh87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in sleep quality (time frame: 12 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?
On the ClinicalTrials.gov record for NCT07176403, which also lists 4 linked publications.
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 16 Sep 2025.