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

A

Alexandria University

Status

Enrolling

Conditions

Intradialytic Exercise

Treatments

Other: control group
Other: intradialytic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07176403
exercise effect on HD patients

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups, including a placebo group

Exercise group
Experimental group
Description:
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.
Treatment:
Other: intradialytic exercise
control group
Placebo Comparator group
Description:
50 patients will not perform exercise during hemodialysis session
Treatment:
Other: control group

Trial contacts and locations

1

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Central trial contact

Mohamed mamdouh Elsayed, MD

Data sourced from clinicaltrials.gov

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