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Completed

NCT Number: NCT07083843

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

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.

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Key information

Conditions

Exercise Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Motor Activity Renal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suwaiq Renal Dialysis unit.

Sohar, Batinah North, 315, Oman

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years of age
  • Diagnosis of ESRD on dialysis at least for 3 years
  • Stable (no recent exacerbation).
  • Not having Diabetic feet.
  • Walking without assistance.

Exclusion criteria

  • Any acute or chronic condition that would limit the ability of the patient to participate in the study.
  • Refusal to give informed consent

Treatment and study plan

Exercise

Behavioral

Intervention, will receive home based exercise multi times per week for 6 months

Standard Medical Treatment

Other

Control group will receive the usual standard care.

Primary outcomes

  1. Change in Depression Score (PHQ-9) From Baseline to 6 Months.

    Time frame: Baseline (prior to intervention.) and 6 months after intervention.

    Depression severity was assessed using the PHQ-9 questionnaire ( patient health questionnaire-9), which consists of 9 questions rated on 4- points Likert scale from 0 (not at all)to 3 (nearly every day). the total score ranges from 0 to 27, with higher scores indicating more severe depression,

    Depression Severity levels :

    Low depression severity (1-9 points) Medium depression severity (10-14 points) and High depression severity (15-27 points). The outcome measure represents the change in PHQ-9 from baseline (pre- intervention) to 6 months post-intervention.

    The change in depression score was calculated by subtracting the score at 6 months from the score at baseline. this calculation was performed for both the intervention and control groups to evaluate the effectiveness of the exercise- based intervention.

  2. Change in Anxiety Score (GAD-7) From Baseline to 6 Months.

    Time frame: Baseline (prior to intervention.) and 6 months after intervention.

    Anxiety severity was assessed using the GAD-7 tool (General Anxiety disorder-7), which consists of 7 questions rated on 4- points Likert scale from 0 (not at all)to 3 (nearly every day). the total score ranges from 0 to 21, with higher scores indicating more severe anxiety,

    Anxiety Severity levels :

    Low Anxiety severity (1-9 points) Medium Anxiety severity (10-14 points) and High Anxiety severity (15-21 points). The outcome measrues represents the change in GAD_7 scores from baseline (pre-intervention) to 6 months post- intervention.

    The change in Anxiety score was calculated by subtracting the score at 6 months from the score at baseline. this calculation was performed for both the intervention and control groups to evaluate the effectiveness of the exercise- based intervention.

Sponsors and collaborators

Lead sponsor

Oman Ministry of Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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