Social Functioning, Alexithymia and Sense of Coherence , Bipolar DisordersNCT05741281
The Effect of Physical Exercises Program on Social Functioning, Alexithymia and Sense of Coherence Among Patients With Bipolar Disorders
A study testing Physical exercises program in people with Social Functioning, Alexithymia and Sense of Coherence , Bipolar Disorders, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Social Functioning, Alexithymia and Sense of Coherence , Bipolar Disorders
- What is being tested?
- Physical exercises program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2022to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Physical exercises program
- Medical subject headings
- Social Adjustment, Affective Symptoms, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercises programBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | Experimental | 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). Receives: Behavioral: Physical exercises program |
| Control group | Active comparator | Those in the control group will be left to undergo the usual hospital routine Receives: Behavioral: Physical exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start5 Feb 2022
- Primary completion5 Dec 2022
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Functioning, Alexithymia and Sense of Coherence , Bipolar DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741281
- Sponsor's protocol ID
- 1692022
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Exercises Program on Social Functioning, Alexithymia and Sense of Coherence Among Patients With Bipolar Disorders
- ClinicalTrials.gov ID
- NCT05741281
- Acronym / sponsor ID
- 1692022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | Experimental | Behavioral: Physical exercises programPhysical 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). |
| Control group | Active comparator | Behavioral: Physical exercises programThose in the control group will be left to undergo the usual hospital routine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Control group, STUDY GROUP |
Primary outcome
The Social Functioning Scale (SFS)
Time frame: 2 weeks
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
Time frame: 2 weeks
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
Time frame: 2 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercises program in people with Social Functioning, Alexithymia and Sense of Coherence , Bipolar Disorders, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Social Functioning Scale (SFS) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.