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ExerciseNCT07083843

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

A study testing Exercise and Standard medical treatment in people with Exercise and Renal Dialysis, run by Oman Ministry of Health at 1 site in Oman.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Exercise, Renal Dialysis, Anxiety
What is being tested?
Exercise and Standard medical treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteOman
Study dates
15 Aug 2024to 1 Jul 2025
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Oman1 site
  • Suwaiq Renal Dialysis unit.

    Sohar, Batinah North, 315

Other trials in Oman

About this study

Official title: The Effect of Non-pharmacological (Exercise Home-based Method) Intervention on Psychological Distress of Patients Undergoing Hemodialysis at Al-Suwaiq Renal 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.
Read the 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.

Being tested
Exercise, Standard medical treatment
Medical subject headings
Motor Activity, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

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

  • Standard medical treatmentOther

    Control group will receive the usual standard care.

Study groups in NCT07083843
Study groupRoleWhat they receive
Intervention group received home based exercise.ExperimentalReceived 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.
Receives: Behavioral: Exercise
Control groupActive comparatorThis group will receive the standard care as usual.
Receives: Other: Standard medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start15 Aug 2024
  3. Primary completion20 Jun 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083843
Sponsor's protocol ID
MoH/CSR/24/28651
Status last verified
Sep 2025
First submitted
5 Jul 2025
Last updated
8 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Saving patients data, confidentiality.

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