Exercise Effect on Psychological Distress of Patients Undergoing Hemodialysis at Al-Suwaiq Dialysis Center
NCT ID: NCT07083843
Last Updated: 2025-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2024-08-15
2025-07-01
Brief Summary
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the main questions aims to answer,
1. Does hemodialysis patients have high level of psychological distress.
2. Does exercise has effect on reducing psychological distress on hemodialysis patients.
participants randomized into control and intervention group, intervention group received home based exercise for 6 month while control group not, to compare in reducing of psychological distress.
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Detailed Description
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This is a two-phases study in which a cross-sectional study will be conducted to evaluate the level of psychological distress among (n=132) patient undergoing hemodialysis at Al- Suwaiq renal dialysis center. as second phase patients randomize into two groups, One group will receive the non- pharmacological intervention (exercise home based) while the other group will continue the regular treatment plan. After 6 months of follow-up, a post-assessment of the psychological symptoms of the interventional and the control groups, using the same tool designed by University of Michigan Depression Center. A face-to-face survey will be applied among selected patients. A paired t-test will be used to assess the expected improvement due to the intervention program by comparing the pre-post assessments of psychological distress level. This study is expected to provide an alternative method of treatment to help renal patients to cope with their treatment consequences.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group received home based exercise.
Received home based exercise as following:
1. Exercise (such as walking or biking) for 5 to 10 minutes. once a day or a few times throughout the day.
2. Slowly adding 3 to 5 minutes to the exercise session. And keep adding time up to 30 to 60 minutes in 1 session.
3. Begin exercising 2 to 3 days a week on the days free of a dialysis treatment.
4. Then increase exercise session 4 to 7 times.
Exercise
Intervention, will receive home based exercise multi times per week for 6 months
Control group
This group will receive the standard care as usual.
Standard medical treatment
Control group will receive the usual standard care.
Interventions
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Exercise
Intervention, will receive home based exercise multi times per week for 6 months
Standard medical treatment
Control group will receive the usual standard care.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ESRD on dialysis at least for 3 years
* Stable (no recent exacerbation).
* Not having Diabetic feet.
* Walking without assistance.
Exclusion Criteria
* Refusal to give informed consent
18 Years
ALL
No
Sponsors
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Oman Ministry of Health
OTHER_GOV
Responsible Party
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Locations
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Suwaiq Renal Dialysis unit.
Sohar, Batinah North, Oman
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Related Info
Related Info
Related Info
Related Info
Other Identifiers
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MoH/CSR/24/28651
Identifier Type: -
Identifier Source: org_study_id
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