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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,
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group received home based exercise. | Experimental | Received home based exercise as following:
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| Control group | Active Comparator | This group will receive the standard care as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Intervention, will receive home based exercise multi times per week for 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suwaiq Renal Dialysis unit. | Sohar | Batinah North | 315 | Oman |
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| Label | URL |
|---|---|
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Saving patients data, confidentiality.
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We started with 54 who were fit with our inclusion criteria, during second phase of intervention, one from intervention group withdraw as he is went into transplantation operation, and one from control group passed away. this lead as to 52 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention group. | after randomized fit patient and and doing pre assessment of psychological distress this group, received a non-pharmacological exercise home based program that includes:
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| FG001 | Control group | Received standard care as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| assessment/data collection period. |
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| Intervention period. |
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| follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group. | after randomized fit patient and and doing pre assessment of psychological distress this group, received a non-pharmacological exercise home based program that includes:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Region of Enrollment | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Unit on a scale. | Baseline (prior to intervention.) and 6 months after intervention. |
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from enrollment until end of follow-up, up to 6 months
no adverse events were observed or reported during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention group. | after randomized fit patient and and doing pre assessment of psychological distress this group, received a non-pharmacological exercise home based program that includes:
|
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amal Salim AlSahi | OmanMOH | 96103040 | 968 | amalalsahi@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2024 | Sep 11, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2024 | Sep 11, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 30, 2024 | Jul 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Standard medical treatment | Other | Control group will receive the usual standard care. |
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| Related Info | View source |
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| BG001 | Control Group | Received the standard care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Generalized anxiety disorder. | Through using approved survey from depression center of Michigan university, all participants were assessed before and after the intervention to measures any significant effect, this questionnaire consists of 7 questions with a four-point response option. The scoring is as follows: Low to mild anxiety severity (1-9 points), Medium anxiety severity (10-14 points), and High anxiety severity (15-21 points). | Mean | Standard Deviation | score on a scale (GAD-7) |
|
| Depression Scale | Through using approved survey from depression center of Michigan university, all participants were assessed before and after the intervention to measures any significant effect, this depression questionnaire consists of 9 questions with a four-point response option. with the scoring: Low depression severity (1-9 points), Medium depression severity (10-14 points), and High depression severity (15-27 points).applied face to face interviewing | Mean | Standard Deviation | score on a scale (PHQ_9) |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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after randomized fit patient and and doing pre assessment of psychological distress this group, received a non-pharmacological exercise home based program that includes:
|
| OG001 | control group | this group received standard care as usual. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Unit on a scale. | Baseline (prior to intervention.) and 6 months after intervention. |
|
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| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | control group | this group received standard care as usual. | 0 | 52 | 0 | 52 | 0 | 52 |
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| >=65 years |
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A superiority analysis was performed to compare depression and anxiety scores between the intervention and control groups. |