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
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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 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 groups in NCT07083843
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.

15 Aug 20241 Jul 2025

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)

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07083843
Acronym / sponsor ID: MoH/CSR/24/28651
Conditions: Exercise, Renal Dialysis, Anxiety, Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Oman Ministry of HealthOther government
Study start: 15 Aug 2024 (actual)
Primary completion: 20 Jun 2025 (actual)
Study completion: 1 Jul 2025 (actual)
First posted: 24 Jul 2025 (actual)
Results: Posted 8 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention group received home based exercise.	Experimental	Behavioral: ExerciseReceived 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.
Control group	Active comparator	Other: Standard medical treatmentThis group will receive the standard care as usual.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExerciseIntervention, will receive home based exercise multi times per week for 6 months	Behavioural	Intervention group received home based exercise.
Standard medical treatmentControl group will receive the usual standard care.	Other	Control group

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 8 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention group.	27	27
Control group	27	27

Primary outcome: Change in Depression Score (PHQ-9) From Baseline to 6 Months.

Time frame: Baseline (prior to intervention.) and 6 months after intervention.. Mean (Standard Deviation). Unit: Unit on a scale.

Measure	Intervention group. n = 26	control group n = 26
Value	2.96 (1.871)	8.00 (5.710)

Intervention group. vs control group: Mean Difference (Final Values): 4.115 (95% CI 2.87 to 5.36), p = 0.05, paired sample T-test.

Primary outcome: Change in Anxiety Score (GAD-7) From Baseline to 6 Months.

Time frame: Baseline (prior to intervention.) and 6 months after intervention.. Mean (Standard Deviation). Unit: Unit on a scale.

Measure	Intervention group. n = 26	control group n = 26
Value	4.80 (4.030)	6.69 (4.412)

Intervention group. vs control group: Mean Difference (Final Values): 2.192 (95% CI 0.986 to 3.238), p = 0.05, paired sample T-test.

Adverse events

Time frame: from enrollment until end of follow-up, up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention group.	0 of 52 (0%)	0 of 52 (0%)	0 of 52
control group	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Saving patients data, confidentiality.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression Score (PHQ-9) From Baseline to 6 Months. (time frame: Baseline (prior to intervention.) and 6 months after intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07083843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.