Clinical trial NCT05741281: The Effect of Physical Exercises Program on Social Functioning, Alexithymia and Sense of Coherence Among Patients With Bipolar Disorders
Official title: The Effect of Physical Exercises Program on Social Functioning, Alexithymia and Sense of Coherence Among Patients With Bipolar Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Functioning, Alexithymia and Sense of Coherence , Bipolar Disorders
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to:

Investigate the effect of applying physical exercises program on social functioning, alexithymia and sense of coherence among patients with bipolar disorders Research Hypotheses

* Clients who participated in physical exercises program will exhibit better social functioning and sense of coherence than the control group.
* Clients who participated in physical exercises program will exhibit less alexithymia than the control group.

Detailed description: * Psychotic male patients' wards will be randomly selected using simple random sampling technique. The first selected ward will be assigned for the first small study group and its control group. The second selected ward will be assigned for the second study and control group and so on. Then the wards will be revisited again in the same order to achieve the required number of subjects.
* Patients' medical charts in the selected wards will be reviewed to identify those who meet the inclusion criteria. From all patients who meet the predetermined inclusion criteria in the selected ward, the patients will be recruited using simple randomization technique.
* A medical checkup will be performed for patients in the study group to exclude any contraindications for carrying out physical exercise.
* The study group (20 patients) will be divided into 4 small groups of 5 patients. Every patient will be interviewed individually to establish rapport and build trustful relationship. Time of each interview will take from 15 to 30 minutes according to patient's familiarity with the researcher, willingness to talk or cooperate and cognitive abilities. By the end of these interviews, the researcher will explain the purpose of the study, and an informed written consent will be obtained from each patient.
* Patients from the study and control groups will be interviewed and observed individually by the researcher to apply the study tools.
* Physical exercises will be carried out for patients in the study group while those in the control group will be left to undergo the usual hospital routine. The physical exercise intervention phase will take three weeks for each patient (three sessions per week for three weeks - Nine sessions for each group). It will be applied for two groups each week for three weeks (one group / day - 3 sessions /week for each group - six days/ week for the two groups).
* Patients' addresses and telephone numbers will be kept in confidential notebook by the researcher after taking their permission to facilitate follow up of patients at the outpatient level to collect data after intervention.
* After termination of the physical exercise program, every patient recruited in both groups will be interviewed immediately using the study tools. In addition, after three months of discharge, patients in both groups will be interviewed and observed at the outpatient level.

Eligibility criteria: Inclusion Criteria:

male patients with no co-morbidity, with duration of illness not exceeding 10 years, physically fit to be able to participate in physical exercise (based on physician recommendations), recently admitted (2 - 3 weeks) Exclusion Criteria

Primary outcomes:
measure: The Social Functioning Scale (SFS)
timeFrame: 2 weeks
measure: Toronto Alexithymia Scale
timeFrame: 2 weeks
measure: The Sense of Coherence
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
References: