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IRCT20210703051765N1 IRCT 2021-09-16 Tehran University of Medical Sciences The effect of exercise therapy and lifestyle modification on metabolic syndrome components in patients with severe mental illness 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 2021-07-04 anticipated 100 Complete https://irct.ir/trial/57281 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. N/A Condition 1: schizophrenia. Condition 2: schizoaffective disorder. Condition 3: bipolar disorder. Condition 4: depressive disorders without psychotic feature. Condition 5: depressive disorders with psychotic feature. 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.. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to ethical concerns the data will not be published.
public Zahra Mirsepassi
Roozbeh Hospital, South Kargar Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 mirsepassizahra@gmail.com Tehran University of Medical Sciences scientific Zahra Mirsepassi
Roozbeh Hospital, South Kargar Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 mirsepassizahra@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with severe mental illness In the remission phase Under the treatments 18 years 50 years Both Substance use in the last month Presence of any uncontrolled medical or neurological disease Diabetes mellitus Heart disease Uncontrolled seizure Musculoskeletal disease F20 F25 F31 F32.2 F32.3 Schizophrenia Schizoaffective disorders Bipolar disorder Major depressive disorder without psychotic features Major depressive disorder with psychotic features Rehabilitation 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. 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. Weight. Timepoint: Before starting the intervention/after 10 sessions of exercise therapy/after 20 sessions of exercise therapy. Method of measurement: Scale. Blood Glucose. Timepoint: Before starting the intervention and after 20 sessions of exercise therapy. Method of measurement: Lab tests. Lipid profile. Timepoint: Before starting the intervention and after 20 sessions of exercise therapy. Method of measurement: Lab tests. Systolic blood pressure. Timepoint: Before starting the intervention/after 10 sessions of exercise therapy/after 20 sessions of exercise therapy. Method of measurement: Sphygmomanometer. Diastolic Blood pressure. Timepoint: Before starting the intervention/after 10 sessions of exercise therapy/after 20 sessions of exercise therapy. Method of measurement: Sphygmomanometer. Global assessment of functioning. Timepoint: Before the intervention/at the end of the intervention. Method of measurement: GAF scale. Tehran University of Medical Sciences Approved 2021-06-22 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Poorsina Ave, Ghods Ave, Enghelab Ave Tehran Tehran Iran (Islamic Republic of)