Anxiety, Depression, Exercise, Renal Dialysis
Conditions
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. 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.
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.
Interventions
BEHAVIORALExercise
Intervention, will receive home based exercise multi times per week for 6 months
OTHERStandard medical treatment
Control group will receive the usual standard care.
Sponsors
Oman Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Any acute or chronic condition that would limit the ability of the patient to participate in the study. * Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Score (PHQ-9) From Baseline to 6 Months. | 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. | 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. |
Countries
Oman
Participant flow
Recruitment details
1. Adults ≥18 years of age 2. Diagnosis of ESRD on dialysis at least for 3 years 3. Stable (no recent exacerbation). 4. Not having Diabetic feet. 5. Walking without assistance.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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:
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. the intervention has been followed for 6 months. | 26 |
| Control Group Received the standard care. | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Intervention period. | Death | 0 | 1 |
| Intervention period. | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention Group. | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 10 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 42 Participants | 19 Participants |
| Depression Scale | 2.96 score on a scale (PHQ_9) STANDARD_DEVIATION 1.871 | 5.48 score on a scale (PHQ_9) STANDARD_DEVIATION 4.68 | 8.00 score on a scale (PHQ_9) STANDARD_DEVIATION 5.71 |
| Generalized anxiety disorder. | 4.8 score on a scale (GAD-7) STANDARD_DEVIATION 4.03 | 5.75 score on a scale (GAD-7) STANDARD_DEVIATION 4.29 | 6.69 score on a scale (GAD-7) STANDARD_DEVIATION 4.412 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Oman | 26 Participants | 52 Participants | 26 Participants |
| Sex: Female, Male Female | 12 Participants | 26 Participants | 14 Participants |
| Sex: Female, Male Male | 14 Participants | 26 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
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.
Time frame: Baseline (prior to intervention.) and 6 months after intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention group. | Change in Anxiety Score (GAD-7) From Baseline to 6 Months. | 4.80 Unit on a scale. | Standard Deviation 4.03 |
| control group | Change in Anxiety Score (GAD-7) From Baseline to 6 Months. | 6.69 Unit on a scale. | Standard Deviation 4.412 |
Comparison: data were processed and analyzed using the SPSS software, version 22.0. The descriptive statistics were calculated, including frequencies and percentages for categorical data, and means and standard deviations for numerical variables. A paired t-test was used to assess the change in the psychological level before and after the intervention program. All hypothesis testing was done at the 5% level of significancep-value: 0.0595% CI: [0.986, 3.238]paired sample T-test.
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.
Time frame: Baseline (prior to intervention.) and 6 months after intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention group. | Change in Depression Score (PHQ-9) From Baseline to 6 Months. | 2.96 Unit on a scale. | Standard Deviation 1.871 |
| control group | Change in Depression Score (PHQ-9) From Baseline to 6 Months. | 8.00 Unit on a scale. | Standard Deviation 5.71 |
Comparison: Data was analyzed using SPSS v22.0., Descriptive statistics will summarize baseline variables. Paired t-test will assess pre- vs. post - intervention scores within groups, and between-group differences will be compared, the null hypothesis states there is no difference between intervention and control groups. A two-tailed P\< 0.05 will be considered statistically significant.p-value: 0.0595% CI: [2.87, 5.36]paired sample T-test.