Trial Outcomes & Findings for Exercise Effect on Psychological Distress of Patients Undergoing Hemodialysis at Al-Suwaiq Dialysis Center (NCT NCT07083843)
NCT ID: NCT07083843
Last Updated: 2025-12-08
Results Overview
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.
COMPLETED
NA
54 participants
Baseline (prior to intervention.) and 6 months after intervention.
2025-12-08
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Control group
Received standard care as usual.
|
|---|---|---|
|
assessment/data collection period.
STARTED
|
27
|
27
|
|
assessment/data collection period.
COMPLETED
|
27
|
27
|
|
assessment/data collection period.
NOT COMPLETED
|
0
|
0
|
|
Intervention period.
STARTED
|
27
|
27
|
|
Intervention period.
COMPLETED
|
26
|
26
|
|
Intervention period.
NOT COMPLETED
|
1
|
1
|
|
follow-up
STARTED
|
26
|
26
|
|
follow-up
COMPLETED
|
26
|
26
|
|
follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Control group
Received standard care as usual.
|
|---|---|---|
|
Intervention period.
Withdrawal by Subject
|
1
|
0
|
|
Intervention period.
Death
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group.
n=26 Participants
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.
|
Control Group
n=26 Participants
Received the standard care.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=26 Participants
|
19 Participants
n=26 Participants
|
42 Participants
n=52 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=26 Participants
|
7 Participants
n=26 Participants
|
10 Participants
n=52 Participants
|
|
Region of Enrollment
Oman
|
26 Participants
n=26 Participants
|
26 Participants
n=26 Participants
|
52 Participants
n=52 Participants
|
|
Generalized anxiety disorder.
|
4.8 score on a scale (GAD-7)
STANDARD_DEVIATION 4.030 • n=26 Participants
|
6.69 score on a scale (GAD-7)
STANDARD_DEVIATION 4.412 • n=26 Participants
|
5.75 score on a scale (GAD-7)
STANDARD_DEVIATION 4.29 • n=52 Participants
|
|
Depression Scale
|
2.96 score on a scale (PHQ_9)
STANDARD_DEVIATION 1.871 • n=26 Participants
|
8.00 score on a scale (PHQ_9)
STANDARD_DEVIATION 5.710 • n=26 Participants
|
5.48 score on a scale (PHQ_9)
STANDARD_DEVIATION 4.68 • n=52 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=26 Participants
|
14 Participants
n=26 Participants
|
26 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=26 Participants
|
12 Participants
n=26 Participants
|
26 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention group.
n=26 Participants
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.
|
control group
n=26 Participants
this group received standard care as usual.
|
|---|---|---|
|
Change in Depression Score (PHQ-9) From Baseline to 6 Months.
|
2.96 Unit on a scale.
Standard Deviation 1.871
|
8.00 Unit on a scale.
Standard Deviation 5.710
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention group.
n=26 Participants
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.
|
control group
n=26 Participants
this group received standard care as usual.
|
|---|---|---|
|
Change in Anxiety Score (GAD-7) From Baseline to 6 Months.
|
4.80 Unit on a scale.
Standard Deviation 4.030 • Interval 4.03 to 2.8
|
6.69 Unit on a scale.
Standard Deviation 4.412 • Interval 4.412 to 0.865
|
Adverse Events
Intervention group.
control group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place