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

NCT07176403 | Recruiting

• 1 other identifier: exercise effect on HD patients
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

this study aims To assess the effect of intradialytic exercise program on sleep quality, depression and anxiety in HD Patients.

Conditions

Intradialytic Exercise

Keywords

Intradialytic exercise; sleep; depression; anxiety; hemodialysis

Outcome Measures

Primary Outcomes (3)

• change in sleep quality

  by using The Pittsburgh sleep Quality Index (PSQI).

  12 weeks

• change in depression scale

  by using Beck Depression inventory (BDI)

  12 weeks

• change in anxiety level

  by using The Beck Anxiety Inventory (BAI) scoring

  12 weeks

Secondary Outcomes (2)

• effect on dialysis adequacy

  12 weeks

• effect on lipid profile

  12 weeks

Study Arms (2)

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.

Other: intradialytic exercise

control group

PLACEBO COMPARATOR

50 patients will not perform exercise during hemodialysis session

Other: control group

Interventions

intradialytic exercise 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.

Exercise group

control group OTHER

50 patients will not perform exercise during hemodialysis session

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 22111062 BACKGROUND

• 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.

  PMID: 26997387 BACKGROUND

• 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.

  PMID: 26163057 BACKGROUND

• 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.

  PMID: 22923917 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mohamed mamdouh Elsayed, MD

  Associate professor

  PRINCIPAL INVESTIGATOR

• Iman Ezzat Elgohary, MD

  professor

  PRINCIPAL INVESTIGATOR

• Marwa Mohamed Hassan, MD

  professor

  STUDY CHAIR

• Heba Essam Abou EL wafa, MD

  professor

  STUDY CHAIR

• Raghda Ashraf AboTawila, MBBCh

  resident

  STUDY CHAIR

Central Study Contacts

Mohamed mamdouh Elsayed, MD

CONTACT

00201068055103; dr_mohamedmamdouh87@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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).

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: July 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 15, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

EG (1)