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IRCT20211011052727N1 IRCT 2022-05-19 Khyber Medical University Effectiveness of Aerobic Exercises as an Adjunctive Therapy In Depression: A Randomized Controlled Trial Effectiveness of Aerobic Exercises as an Adjunctive Therapy In Depression: A Randomized Controlled Trial 2022-05-31 anticipated 32 Complete https://irct.ir/trial/63467 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After meeting the inclusion criteria and filling a written informed consent, a total of 32 patients will be enrolled in this study. These participants will be randomly allocated into two groups namely; the Experimental group (aerobic exercises and antidepressants) and the Control group (antidepressants only). The random allocation will be performed using sealed envelope (opaque). Total 32 envelopes will be prepare, 16 will have a paper with group A (control group: antidepressants) written on it and 16 will have group B (experimental group: aerobic exercises and antidepressants). This will be for equal distribution of subjects in the two groups. Each participant will be asked to pick an envelope and he/she will hand over the envelop to the researcher. Participants were not blinded about their allocation as it was not possible. All the participants were well informed about the goals and intervention of the study by providing detailed, Blinding description: the investigator was unawear of the patient level of depression and of the detail of weather the patient is in the control group or experimental group. N/A Depression. Intervention 1: Intervention group: Aerobic Exercises and Antidepressants (n=16) Exercises: three days for 8 weeks• 5 mins warm up, 30 mins treadmill walk, 5 mins cool down (1st 4 weeks)• 5 mins warm up, 30 mins cycling on cycle ergometer, 5 mins cool (next 4 weeks). Intervention 2: Control group: Antidepressant drugs (n=16) for 16 weeks types and dosage as per the condition of the patient ( prescribe by a Psychiatrist). No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no further information
public Farooqi Salman
K5/47 Phase 3 hayatabad Peshawar
Peshawar Pakistan 25001 +92 345 2231141 salmankmu@gmail.com Khyber Medical University scientific Salman Farooqi
Phase 5 hayatabad
Peshawar Pakistan 25001 +92 91 5823496 salman.farooqi@kmu.edu.pk Khyber Medical University Peshawar Pakistan Pakistan This study included both male and females patients patients with mild to severe depression will be included in the study Patients who resided in Peshawar Pakistan and had an easy access to the aforementioned clinic or the i-fitness gym of Iqra National University, Peshawar will be included. patients with the age between 18-35 will be included 18 years 35 years Both Patients who are currently enrolled in any other clinical study/trial Patients who are involved in any sporting or exercise activity at the time of this study conduction Anyone who could not participate in any physical activity Patients having other psychiatric or physical disorder will be excluded from this study Patients who are taking any antipsychotic drugs or psychotherapy within last 3 months before the commencement of the present study will be excluded F06.31 Mood disorder due to known physiological condition with depressive features Rehabilitation Treatment - Drugs Intervention group: Aerobic Exercises and Antidepressants (n=16) Exercises: three days for 8 weeks• 5 mins warm up, 30 mins treadmill walk, 5 mins cool down (1st 4 weeks)• 5 mins warm up, 30 mins cycling on cycle ergometer, 5 mins cool (next 4 weeks) Control group: Antidepressant drugs (n=16) for 16 weeks types and dosage as per the condition of the patient ( prescribe by a Psychiatrist) The primary outcome is the level of depression. Timepoint: 8 weeks. Method of measurement: Hamilton Depression rating scale. Khyber Medical University Approved 2022-03-25 ethical review committee of Khyber Medical University Phase 5 Hayatabad Peshawar Peshawar Khyber Pukhtoonkhwa Pakistan