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

NCT ID: NCT07176403

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-11-15

Brief Summary

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.

Conditions

Intradialytic Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

intradialytic exercise

Intervention Type: OTHER

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.

control group

50 patients will not perform exercise during hemodialysis session

Group Type: PLACEBO_COMPARATOR

control group

Intervention Type: OTHER

50 patients will not perform exercise during hemodialysis session

Interventions

intradialytic 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.

Intervention Type: OTHER

control group

50 patients will not perform exercise during hemodialysis session

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed mamdouh Elsayed, MD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Iman Ezzat Elgohary, MD

Role: PRINCIPAL_INVESTIGATOR

professor

Marwa Mohamed Hassan, MD

Role: STUDY_CHAIR

professor

Heba Essam Abou EL wafa, MD

Role: STUDY_CHAIR

professor

Raghda Ashraf AboTawila, MBBCh

Role: STUDY_CHAIR

resident

Locations

Faculty of Medicine, Aexandria University

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed mamdouh Elsayed, MD

Role: CONTACT

dr_mohamedmamdouh87@yahoo.com

00201068055103

Facility Contacts

mohamed mamdouh elsayed, MD

Role: primary

dr_mohamedmamdouh87@yahoo.com

00201068055103

References

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.

Reference Type: BACKGROUND

PMID: 22111062 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26997387 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26163057 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22923917 (View on PubMed)

Other Identifiers

exercise effect on HD patients

Identifier Type: -

Identifier Source: org_study_id