Clinical Trials Directory

Trials / Completed

CompletedNCT07083843

Exercise Effect on Psychological Distress of Patients Undergoing Hemodialysis at Al-Suwaiq Dialysis Center

The Effect of Non-pharmacological (Exercise Home-based Method) Intervention on Psychological Distress of Patients Undergoing Hemodialysis at Al-Suwaiq Renal Dialysis Center

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Oman Ministry of Health · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim to investigate the level of psychological distress on patients undergoing hemodialysis at Al-Suwaiq Renal dialysis center as well as to explore the effectiveness of home-based exercise method in reducing such psychological distress, depression, and anxiety. 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.

Detailed description

Patients with kidney failure undergoing hemodialysis experience psychological distress.Several psychosocial stressors have an impact on patients undergoing hemodialysis as dialysis treatment imposes several lifestyle changes. These include the impact of disease and treatment, dietary and fluid restrictions, functional limitations, sexual dysfunction, future uncertainty and fear of death. Commonly associated psychosocial issues include depression and anxiety. Exercise interventions may mitigate this outcome, but their clinical role is unclear. Thus. this project aims to examine the effect of non- pharmacological intervention exercise, walking, in reducing psychological distress. 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

Interventions

TypeNameDescription
BEHAVIORALExerciseIntervention, will receive home based exercise multi times per week for 6 months
OTHERStandard medical treatmentControl group will receive the usual standard care.

Timeline

Start date
2024-08-15
Primary completion
2025-06-20
Completion
2025-07-01
First posted
2025-07-24
Last updated
2025-12-08
Results posted
2025-12-08

Locations

1 site across 1 country: Oman

Source: ClinicalTrials.gov record NCT07083843. Inclusion in this directory is not an endorsement.