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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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,
- Does hemodialysis patients have high level of psychological distress.
- 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.
- Conditions
- Exercise, Renal Dialysis, Anxiety, Depression
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise |
| Control group | Active comparator | This 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.
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.
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.
- First posted24 Jul 2025
- Study start15 Aug 2024
- Primary completion20 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Saving patients data, confidentiality.