this study aim is to compare the effectiveness of aerobic exercises as an adjunctive therapy along with antidepressants on depression.
Design
In this observer blinded Randomised Controlled Trial, total 32 patients with depression were recruited via consecutive sampling. Both groups were having equal number of patients that is 16 in each.
Settings and conduct
I-fitness Gym of Iqra National Univeristy Peshawar Pakistan
Participants/Inclusion and exclusion criteria
This study will include patients (both male and females) with mild to severe depression of age 18-35. 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 Pakistan will be included.
Patients who had participated in any other clinical study/trial at the time the present study will be excluded patients who is involved in any sporting or exercise activity at the time of this study conduction or anyone who could not participate in any physical activity or had any other psychiatric or physical disorder will be excluded from this study. Patients who had been taking any antipsychotic drugs or psychotherapy within last 3 months before the commencement of the present study will also be excluded.
Intervention groups
The experimental group received aerobic exercises and antidepressants while the controls received only antidepressants for 8 weeks.
Main outcome variables
The primary outcome measures were Hamilton Depression rating scale (HDRS) and Beck Depression Inventory-II (BDI-II).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211011052727N1
Registration date:2022-05-19, 1401/02/29
Registration timing:prospective
Last update:2022-05-19, 1401/02/29
Update count:0
Registration date
2022-05-19, 1401/02/29
Registrant information
Name
Salman farooqi
Name of organization / entity
Khyber Medical University Peshawar Pakistan
Country
Pakistan
Phone
+92 91 5823496
Email address
salman.farooqi@kmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-31, 1401/03/10
Expected recruitment end date
2022-09-01, 1401/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Aerobic Exercises as an Adjunctive Therapy In Depression: A Randomized Controlled Trial
Public title
Effectiveness of Aerobic Exercises as an Adjunctive Therapy In Depression: A Randomized Controlled Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical review committee of Khyber Medical University
Street address
Phase 5 Hayatabad Peshawar
City
Peshawar
Postal code
25001
Approval date
2022-03-25, 1401/01/05
Ethics committee reference number
KMU/ERC- 15011
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
Primary outcomes
1
Description
the primary outcome is the level of depression
Timepoint
8 weeks
Method of measurement
Hamilton Depression rating scale
Secondary outcomes
empty
Intervention groups
1
Description
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)
Category
Rehabilitation
2
Description
Control group: Antidepressant drugs (n=16) for 16 weeks types and dosage as per the condition of the patient ( prescribe by a Psychiatrist)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Iqra National University
Full name of responsible person
Dr. Eiman Summaya
Street address
Hayatabad Phase 2 Peshawar Pakistan
City
Peshawar
Postal code
25000
Phone
+92 315 9710104
Email
eimaanktk@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khyber Medical University
Full name of responsible person
Dr Masood Ifrah
Street address
Hayatabad Phase 5 Peshawar Pakistan
City
Peshawar
Postal code
25001
Phone
+92 321 6710675
Email
ifrah.masood@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khyber Medical University
Proportion provided by this source
100
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
Khyber Medical University
Full name of responsible person
Farooqi Salman
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
K5/47 Phase 3 hayatabad Peshawar
City
Peshawar
Province
Khyber Pukhtunkhwa
Postal code
25001
Phone
+92 345 2231141
Email
salmankmu@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khyber Medical University Peshawar Pakistan
Full name of responsible person
Salman Farooqi
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Phase 5 hayatabad
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25001
Phone
+92 91 5823496
Fax
Email
salman.farooqi@kmu.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Khyber Medical University Peshawar Pakistan
Full name of responsible person
Salman Farooqi
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Phase 5 hayatabad
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25001
Phone
+92 91 5823496
Fax
Email
salman.farooqi@kmu.edu.pk
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
there is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available