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

NCT07083843 | Completed Results

• 1 other identifier: MoH/CSR/24/28651
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does hemodialysis patients have high level of psychological distress.
2. 2.Does exercise has effect on reducing psychological distress on hemodialysis patients.

Conditions

Exercise; Renal Dialysis; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline (prior to intervention.) and 6 months after intervention.

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

  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.

  Baseline (prior to intervention.) and 6 months after intervention.

Study Arms (2)

Intervention group received home based exercise.

EXPERIMENTAL

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.

Behavioral: Exercise

Control group

ACTIVE COMPARATOR

This group will receive the standard care as usual.

Other: Standard medical treatment

Interventions

Standard medical treatment OTHER

Control group will receive the usual standard care.

Control group

Exercise BEHAVIORAL

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

Intervention group received home based exercise.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oman Ministry of Health: lead

Study Sites (1)

Suwaiq Renal Dialysis unit.

Sohar, Batinah North, 315, Oman

Location

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MeSH Terms

Conditions

Motor Activity; Anxiety Disorders; Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The study has several limitations. The sample size was relatively small (n=52 for final analysis), which may affect the generalizability of the findings. Adherence to the home-based exercise regimen was self-reported, which may introduce reporting bias or variability in actual physical activity levels. Additionally, The study duration was six months, which may not be sufficient to assess long-term sustainability

Results Point of Contact

• Title: Amal Salim AlSahi
• Organization: OmanMOH

amalalsahi@gmail.com

96103040

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 24, 2025
• Study Start: August 15, 2024
• Primary Completion: June 20, 2025
• Study Completion: July 1, 2025
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)