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

Primary Purpose

Social Functioning, Alexithymia and Sense of Coherence , Bipolar Disorders

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Physical exercises program
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Social Functioning, Alexithymia and Sense of Coherence , Bipolar Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STUDY GROUP

Control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

The Social Functioning Scale (SFS)
The SFS is a self-administered questionnaire and consists of 79 items with varying response format (dichotomous questions, three point likert scale, four point likert scale and five point likert scale). These items are classified into seven subscales; withdrawal/social engagement )5 items), interpersonal communication (4 items), independence-performance(13 items), independence-competence (13 items), recreation (15 items), prosocial activities (22 items), and employment/occupation(5 items), in addition to two unscored preliminary questions.
Toronto Alexithymia Scale
The Toronto Alexithymia Scale (TAS-20) was developed by (Bagby, Taylor, & Parker, 1994) and it is a 20-items, self-administered questionnaire that measures difficulty in identifying and describing emotions, which is a big part of alexithymia. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
The Sense of Coherence
The SOC scale was developed by Antonovsky to measure the concept of sense of coherence. The short form of the SOC scale consists of 13 items that comprise three components: comprehensibility (to which 5 items contribute), manageability (4 items), and meaningfulness (4 items). The respondents indicate agreement or disagreement on a 7-category semantic differential scale with two anchoring responses tailored to the content of each item. Five items (1, 2, 3, 5, and 7) are reversed before summing the total score. The total score can range from 13 to 91, and a higher score indicates higher SOC

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
February 14, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05741281
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2022 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
February 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Functioning, Alexithymia and Sense of Coherence , Bipolar Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STUDY GROUP
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Those in the control group will be left to undergo the usual hospital routine
Intervention Type
Behavioral
Intervention Name(s)
Physical exercises program
Intervention Description
- 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.
Primary Outcome Measure Information:
Title
The Social Functioning Scale (SFS)
Description
The SFS is a self-administered questionnaire and consists of 79 items with varying response format (dichotomous questions, three point likert scale, four point likert scale and five point likert scale). These items are classified into seven subscales; withdrawal/social engagement )5 items), interpersonal communication (4 items), independence-performance(13 items), independence-competence (13 items), recreation (15 items), prosocial activities (22 items), and employment/occupation(5 items), in addition to two unscored preliminary questions.
Time Frame
2 weeks
Title
Toronto Alexithymia Scale
Description
The Toronto Alexithymia Scale (TAS-20) was developed by (Bagby, Taylor, & Parker, 1994) and it is a 20-items, self-administered questionnaire that measures difficulty in identifying and describing emotions, which is a big part of alexithymia. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Time Frame
2 weeks
Title
The Sense of Coherence
Description
The SOC scale was developed by Antonovsky to measure the concept of sense of coherence. The short form of the SOC scale consists of 13 items that comprise three components: comprehensibility (to which 5 items contribute), manageability (4 items), and meaningfulness (4 items). The respondents indicate agreement or disagreement on a 7-category semantic differential scale with two anchoring responses tailored to the content of each item. Five items (1, 2, 3, 5, and 7) are reversed before summing the total score. The total score can range from 13 to 91, and a higher score indicates higher SOC
Time Frame
2 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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