The Effect of Non-pharmacological (Exercise Home-based Method) Intervention on Psychological Distress of Patients Undergoing Hemodialysis at Al-Suwaiq Renal Dialysis Center
Phase: NA
Conditions: Exercise, Renal Dialysis, Anxiety, Depression
Sponsor: Oman Ministry of Health

 
The Effect of Non-Pharmacological (Home-Based 
Exercise) Intervention on Psychological Distress of 
Patients Undergoing Hemodialysis at Al Suwaiq Renal 
Dialysis Center 
 
 
 
NCT07083843 
 
 
Date: 15/08/2024 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
Background and Rationale 
Patients undergoing hemodialysis experience multiple physical and psychological 
challenges, with depression and anxiety being highly prevalent. These psychological 
burdens negatively affect quality of life, treatment adherence, and long-term outcomes. 
While pharmacological treatments are commonly used, non-pharmacological interventions 
such as exercise have shown promising benefits in improving mental health. 
However, structured facility-based exercise programs are often inaccessible to many dialysis 
patients due to physical, logistical, and economic limitations. Home-based exercise 
programs, which are low-cost and simple to implement, may represent a feasible alternative. 
This study aims to assess the effect of a home-based walking exercise program on reducing 
psychological distress among patients undergoing hemodialysis. 
Study Aim and Objectives 
Aim: To investigate the effectiveness of a non-pharmacological, home-based exercise 
program in reducing psychological distress, depression, and anxiety in patients undergoing 
hemodialysis. 
Objectives: 
1. 
To assess the baseline level of psychological distress among patients undergoing 
hemodialysis. 
2. 
To evaluate the effectiveness of a home-based walking exercise program in reducing 
depression and anxiety scores compared to a control group receiving standard care. 
Hypotheses 
H1: There is a high level of psychological distress among patients undergoing dialysis 
treatment. 

H2: Home-based exercise intervention significantly reduces psychological distress 
(depression and anxiety scores) compared to standard care. 
Study Design 
This research will be conducted in two main phases: 
Phase I: Cross-sectional study to assess baseline levels of depression and anxiety using 
validated tools. 
Phase II: Randomized controlled trial (RCT) with two groups: 
- Intervention Group: Receives structured, home-based walking exercise program for 6 
months. 
- Control Group: Receives standard care without exercise intervention. 
Post-intervention assessment will be conducted for both groups after 6 months using the 
same tools. 
Study Population 
Inclusion Criteria: Adults ≥18 years old; Diagnosis of ESRD on hemodialysis for ≥3 years; 
Stable clinical status; No diabetic foot complications; Able to walk without assistance. 
Exclusion Criteria: Any acute or chronic condition limiting participation in exercise; Refusal 
to give informed consent. 
Sample Size and Sampling Technique 
Using Cochran’s formula for finite populations, with a total population of 132, a 95% 
confidence interval, 5% margin of error, and an estimated prevalence of depression of 73%, 
the calculated sample size is 54 participants. 
Sampling Method: Simple random sampling from the list of eligible patients at Al Suwaiq 
Renal Dialysis Center. 
Intervention 
Home-Based Exercise Program: Walking or cycling for 5–10 minutes once or multiple times 
daily; Gradually increasing duration by 3–5 minutes until reaching 30–60 minutes per 
session; Exercise 2–3 days per week initially, progressing to 4–7 days per week; Performed 
on non-dialysis days. 
Data Collection Tools and Methods 
Depression Assessment: PHQ-9 questionnaire (University of Michigan Depression Center). 
Anxiety Assessment: GAD-7 questionnaire (University of Michigan Depression Center). 

Data will be collected via face-to-face interviews and patient medical records from the Al 
Shifa system. 
Data Analysis Plan 
Data entry and cleaning using SPSS v22; Descriptive statistics for demographics and 
baseline variables; Baseline comparisons using t-tests or non-parametric equivalents; 
Paired t-tests for within-group changes; Independent t-tests for between-group differences; 
Significance set at p < 0.05 (two-tailed). 
Ethical Considerations 
Ethical approval will be obtained from the Institutional Research and Ethics Committee. 
Informed consent will be taken from all participants. Confidentiality will be maintained, and 
participants can withdraw anytime without affecting their treatment. 
Expected Outcomes 
The intervention group is expected to show a statistically significant reduction in 
depression and anxiety scores compared to the control group, supporting the integration of 
home-based exercise programs in dialysis care.