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Recruiting NCT07176403

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

No phase Interventional Intradialytic Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intradialytic exercise, control group.
Who it may be relevant to
Registry conditions: Intradialytic Exercise. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Intradialytic Exercise Program on Sleep Quality, Depression and Anxiety in Hemodialysis Patients

Overview

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.

Interventions

  • Other 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.
  • Other control group
    50 patients will not perform exercise during hemodialysis session

Primary outcome measures

  • change in sleep quality [Time frame: 12 weeks]
  • change in depression scale [Time frame: 12 weeks]
  • change in anxiety level [Time frame: 12 weeks]
Secondary outcome measures (2)
  • effect on dialysis adequacy [Time frame: 12 weeks]
  • effect on lipid profile [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine, Aexandria University — Alexandria

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. PMID 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. PMID 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. PMID 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. PMID 22923917

Identifiers

NCT: NCT07176403 · exercise effect on HD patients

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗