Exercise Effect on Psychological Distress of Patients Undergoing Hemodialysis at Al-Suwaiq Dialysis Center

Oman Ministry of Health

Status: Completed

Conditions: Depression; Anxiety; Renal Dialysis; Exercise

Treatments: Behavioral: Exercise; Other: Standard medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07083843

MoH/CSR/24/28651

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Intervention group received home based exercise.

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Control group

Active Comparator group

Description:

This group will receive the standard care as usual.

Treatment:

Other: Standard medical treatment