CClinicalTrials.gg
RecruitingNCT07176403Updated Sep 16, 2025

Effect of Intradialytic Exercise on Sleep, Depression and Anxiety in HD Patients

An interventional study of intradialytic exercise and control group in Intradialytic Exercise, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Intradialytic Exercise

Keywords

  • Intradialytic exercise
  • sleep
  • depression
  • anxiety
  • hemodialysis
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 100 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ESKD patients on maintenance hemodialysis for more than three months.
  2. Age more than 18 years.

Exclusion criteria

Exclusion Criteria:

  1. Mentally or physically unfit patients or with severe psychiatric illness.
  2. Patients who receive any psychotropic medications.
  3. Patients with overt ischemic heart disease or cardiac decompensation.
  4. Anemic patients (Hb ≤ 8 mg/dl).
  5. Patients presented with severe bone pains or muscle weakness secondary to chronic kidney disease-mineral and bone disorder (CKD-MBD).
  6. Patients with advanced lower limbs joints disease.
  7. Lower limb amputation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Exercise group

    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.

    Other: intradialytic exercise

  • Placebo comparator
    control group

    50 patients will not perform exercise during hemodialysis session

    Other: control group

Interventions

  • Otherintradialytic exercise

    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.

  • Othercontrol group

    50 patients will not perform exercise during hemodialysis session

06

What researchers measure

Primary outcomes

  1. change in sleep quality

    by using The Pittsburgh sleep Quality Index (PSQI).

    Time frame: 12 weeks

  2. change in depression scale

    by using Beck Depression inventory (BDI)

    Time frame: 12 weeks

  3. change in anxiety level

    by using The Beck Anxiety Inventory (BAI) scoring

    Time frame: 12 weeks

Secondary outcomes

  1. effect on dialysis adequacy

    by assessing urea reduction ratio (URR)

    Time frame: 12 weeks

  2. effect on lipid profile

    by assessing triglycerides and cholesterol

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine, Aexandria University
    Alexandria, 21526, Egypt
    Recruiting
08

References and documents

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 22111062 ↗
  • Rajan 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 26997387 ↗
  • Mollayeva 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 26163057 ↗
  • Gordon 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07176403
Lead sponsor
Alexandria University
Responsible party
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD (Associate professor, Alexandria University) — Principal investigator
First posted
Sep 16, 2025
Start date
Jul 15, 2025
Primary completion
Oct 15, 2025 (estimated)
Completion
Nov 15, 2025 (estimated)
Last update
Sep 16, 2025

Study contacts

Mohamed mamdouh Elsayed, MD
Contact
dr_mohamedmamdouh87@yahoo.com
00201068055103
Mohamed mamdouh Elsayed, MD
principal investigator · Associate professor
Iman Ezzat Elgohary, MD
principal investigator · professor
Marwa Mohamed Hassan, MD
study chair · professor
Heba Essam Abou EL wafa, MD
study chair · professor
Raghda Ashraf AboTawila, MBBCh
study chair · resident

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion