The Effect of Physical Exercises Program on Social Functioning, Alexithymia and Sense of Coherence Among Patients With Bipolar Disorders

NCT ID: NCT05741281

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-05
• Study Completion Date: 2023-02-05

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.

Conditions

Social Functioning, Alexithymia and Sense of Coherence , Bipolar Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

STUDY GROUP

Physical exercises will be carried out for patients in the study group . 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).

Group Type: EXPERIMENTAL

Physical exercises program

Intervention Type: BEHAVIORAL

\- Physical exercise program is an innovative exercise program-consisting of three basic parts (warm up - physical fitness - cool down). It was developed previously by the researcher under the supervision of experienced trainer of physical exercise. The session will begin with a 5- to 10-minutes warm-up consisting of stretching and bending movements. This will be followed by physical fitness phase for 30 to 35 minutes which consist of rapid walking accompanied by a variety of arm and leg movements. The session will be ended by a 5- to 10-minutes cool down phase similar to the warm-up. The total time needed for finishing the physical exercise intervention will be approximately 1 hour.

Control group

Those in the control group will be left to undergo the usual hospital routine

Group Type: ACTIVE_COMPARATOR

Physical exercises program

Intervention Type: BEHAVIORAL

\- Physical exercise program is an innovative exercise program-consisting of three basic parts (warm up - physical fitness - cool down). It was developed previously by the researcher under the supervision of experienced trainer of physical exercise. The session will begin with a 5- to 10-minutes warm-up consisting of stretching and bending movements. This will be followed by physical fitness phase for 30 to 35 minutes which consist of rapid walking accompanied by a variety of arm and leg movements. The session will be ended by a 5- to 10-minutes cool down phase similar to the warm-up. The total time needed for finishing the physical exercise intervention will be approximately 1 hour.

Interventions

Physical exercises program

\- Physical exercise program is an innovative exercise program-consisting of three basic parts (warm up - physical fitness - cool down). It was developed previously by the researcher under the supervision of experienced trainer of physical exercise. The session will begin with a 5- to 10-minutes warm-up consisting of stretching and bending movements. This will be followed by physical fitness phase for 30 to 35 minutes which consist of rapid walking accompanied by a variety of arm and leg movements. The session will be ended by a 5- to 10-minutes cool down phase similar to the warm-up. The total time needed for finishing the physical exercise intervention will be approximately 1 hour.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Khedr

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Nursing

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

1692022

Identifier Type: -

Identifier Source: org_study_id