The effect of exercise therapy and lifestyle modification on metabolic syndrome components in patients with severe mental illness referred to exercise therapy unit in outpatient setting
The effect of exercise therapy and lifestyle modification training on the components of metabolic syndrome in patients with severe mental illness
Design
Pretest-posttest
Settings and conduct
The patient's overall performance is determined by the Global Assessment of Functioning (GAF). The patient is checked for metabolic syndrome and the patient's height, weight, blood pressure and waist circumference are measured and BMI is determined and recorded and the patient's level of physical activity is determined based on the interview and 6 min walk test is performed. Some lab tests including fasting blood sugar and lipid profile are requested.
1) 20 sessions of exercise therapy
2) 4 group training sessions of lifestyle modification
The lifestyle modification sessions are held by a trained nurse every week in a group manner. The duration of each session is about 45-30 minutes.
Patients attend exercise therapy sessions under the supervision of a trainer twice a week for 10 weeks.
At the end of 10 weeks, the patient's overall function is determined again and the fasting blood sugar assessment and lipid profile are repeated.
The patient's BMI, blood pressure, and waist circumference are measured and recorded again after 5 weeks and at the end of week 10.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with severe mental illness, in the age range of 18-50 years, in the remission phase and under the medication treatment
Exclusion criteria: Patients with a history of substance abuse in the past month, unstable physical or neurological disorders, patients with diabetes mellitus or heart disease, uncontrolled seizures or musculoskeletal disease
Intervention groups
The intervention includes 20 sessions of exercise therapy and 4 sessions of a nutrition education program.
Main outcome variables
weight
BMI
Waist circumstances
Blood pressure
FBS and lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210703051765N1
Registration date:2021-09-16, 1400/06/25
Registration timing:registered_while_recruiting
Last update:2021-09-16, 1400/06/25
Update count:0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Zahra Mirsepassi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8838 5809
Email address
mirsepassizahra@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-04, 1400/04/13
Expected recruitment end date
2023-07-04, 1402/04/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise therapy and lifestyle modification on metabolic syndrome components in patients with severe mental illness referred to exercise therapy unit in outpatient setting
Public title
The effect of exercise therapy and lifestyle modification on metabolic syndrome components in patients with severe mental illness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe mental illness
In the remission phase
Under the treatments
Exclusion criteria:
Substance use in the last month
Presence of any uncontrolled medical or neurological disease
Diabetes mellitus
Heart disease
Uncontrolled seizure
Musculoskeletal disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poorsina Ave, Ghods Ave, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.320
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
2
Description of health condition studied
schizoaffective disorder
ICD-10 code
F25
ICD-10 code description
Schizoaffective disorders
3
Description of health condition studied
bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
4
Description of health condition studied
depressive disorders without psychotic feature
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder without psychotic features
5
Description of health condition studied
depressive disorders with psychotic feature
ICD-10 code
F32.3
ICD-10 code description
Major depressive disorder with psychotic features
Primary outcomes
1
Description
Waist circumstance
Timepoint
Before starting the intervention/after 10 sessions of exercise therapy/after 20 sessions of exercise therapy
Method of measurement
Centimeter tape measure
2
Description
Weight
Timepoint
Before starting the intervention/after 10 sessions of exercise therapy/after 20 sessions of exercise therapy
Method of measurement
Scale
3
Description
Blood Glucose
Timepoint
Before starting the intervention and after 20 sessions of exercise therapy
Method of measurement
Lab tests
4
Description
Lipid profile
Timepoint
Before starting the intervention and after 20 sessions of exercise therapy
Method of measurement
Lab tests
5
Description
Systolic blood pressure
Timepoint
Before starting the intervention/after 10 sessions of exercise therapy/after 20 sessions of exercise therapy
Method of measurement
Sphygmomanometer
6
Description
Diastolic Blood pressure
Timepoint
Before starting the intervention/after 10 sessions of exercise therapy/after 20 sessions of exercise therapy
Method of measurement
Sphygmomanometer
Secondary outcomes
1
Description
Global assessment of functioning
Timepoint
Before the intervention/at the end of the intervention
Method of measurement
GAF scale
Intervention groups
1
Description
The intervention includes exercise therapy and a nutrition education program. The nutrition educational program includes 4 group educational sessions. The intervention to increase physical activity includes 20 sessions of exercise therapy. Nutrition education program: In the first 4 sessions, patients will participate in a group educational session and then receive exercise therapy intervention. In the following sessions, the individual's nutritional habits will be explored and then exercise therapy will be provided. The training sessions will be held by a trained nurse, occupational therapist or psychologist who has participated in a workshop. These sessions are held every week in a group manner (5-8 people). The duration of each session will be about 30-45 minutes. The first session includes being familiar with the team members and reviewing the basics principles of healthy eating. In the second and third sessions, different food categories, the fiber content of foods, different food calories and the importance of physical activity will be explained. In the fourth session, in addition to review the previous contents, the patients' misconceptions about nutrition, will be discussed. The exercise therapy as an intervention to increase physical activity: The exercise program including 5 to 10 minutes of warm-up (low-intensity exercise with flexibility movements), 15 to 30 minutes of aerobic exercise includes stationary and elliptical cycling, 15 minutes of strength training with the device for upper and lower limbs and 5 minutes of cooling. Exercise intervention will be the same for all patients, and aerobic exercise and moderate-intensity strength exercise will be defined according to the Borg table (between 11 and 14). Exercise therapy sessions will be performed twice a week for 10 weeks (20 sessions of exercise therapy) under the supervision of a trained trainer. The patient's vital signs will be recorded by the nurse, before and after the intervention. The exercise program will be performed under the supervision of a coach for 30-45 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Exercise therapy unit in Roozbeh Hospital
Full name of responsible person
Zahra Mirsepassi
Street address
Roozbeh hospital, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 2222
Email
mirsepassizahra@gmail.com
Web page address
https://roozbehhospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr shahin Akhondzadeh
Street address
Tehran University of Medical Sciences, Poorsina Ave, Ghods Ave, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3405
Email
s.akhond@neda.net
Web page address
http://medicine.tums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Mirsepassi
Position
Assistant professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh Hospital, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mirsepassizahra@gmail.com
Web page address
https://roozbehhospital.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Mirsepassi
Position
Assistant professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh Hospital, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
Email
mirsepassizahra@gmail.com
Web page address
https://roozbehhospital.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Mirsepassi
Position
Assistant professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh Hospital, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mirsepassizahra@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to ethical concerns the data will not be published.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Publication as a manuscript
When the data will become available and for how long
Three years later
To whom data/document is available
The researchers
Under which criteria data/document could be used
Planning for health promotion
From where data/document is obtainable
The journal
What processes are involved for a request to access data/document