Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741281
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2023-02-14
Brief Title:
The Effect of Physical Exercises Program on Social Functioning Alexithymia and Sense of Coherence Among Patients With Bipolar Disorders
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
The Effect of Physical Exercises Program on Social Functioning Alexithymia and Sense of Coherence Among Patients With Bipolar Disorders
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None