Intradialytic exercise to improve sleep, depression, and anxiety in adults on hemodialysis
Effect of Intradialytic Exercise Program on Sleep Quality, Depression and Anxiety in Hemodialysis Patients
This trial will try an exercise program performed during routine hemodialysis to see if it improves sleep quality, depression, and anxiety in adults on maintenance hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07176403 on ClinicalTrials.gov |
What this trial studies
Adults on maintenance hemodialysis will be assigned to an intradialytic exercise program or a control group receiving usual care. The exercise is performed during regular dialysis sessions so it does not require extra clinic visits. Researchers will measure changes in sleep quality, depressive symptoms, and anxiety, along with related clinical measures. Patients with major cardiac disease, severe anemia, significant orthopedic limitations, current psychotropic medication use, or severe psychiatric illness are excluded.
Who should consider this trial
Good fit: Adults over 18 with end-stage kidney disease who have been on maintenance hemodialysis for more than three months and who can safely perform lower-limb exercise are ideal candidates.
Not a fit: Patients with severe cardiac disease, advanced anemia, major psychiatric illness, current use of psychotropic medications, significant lower-limb joint disease, or lower-limb amputation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could improve sleep and mood for people on hemodialysis without adding extra time outside dialysis sessions.
How similar studies have performed: Previous studies have suggested intradialytic exercise can reduce fatigue and improve sleep quality, exercise tolerance, quality of life, and some psychological outcomes, though findings vary between trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ESKD patients on maintenance hemodialysis for more than three months. 2. Age more than 18 years. 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.
Where this trial is running
Alexandria
- Faculty of Medicine, Aexandria University — Alexandria, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed mamdouh Elsayed, MD — Associate professor
- Study coordinator: Mohamed mamdouh Elsayed, MD
- Email: dr_mohamedmamdouh87@yahoo.com
- Phone: 00201068055103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.