Protocol summary

Study aim
Determining the effect of virtual sitting exercises on depression, anxiety and stress in the elderly in the Covid 19 epidemy
Design
Random clinical trial with control and test group, community-based and pragmatic, randomized, Excel software rand function is used for randomization.
Settings and conduct
Obtaining confirmation from the university and the code of ethics - referring to the comprehensive center of health services in Karaj - explanation about Executive plan, purpose and research process - Admission of people to the study in an accessible manner according to the inclusion criteria and sample size - Assignment of a code to each sample and based on randomly assigned blocking to the volume of 4 blocks, individuals as Equal to two groups of control and test - participants complete online demographic questionnaire and dass-21- Perform sports exercises online through the Skype application by a sports coach, for 12 weeks, three days a week, 30-45 minutes - Send sport video for the control group in WhatsApp - Take the dass-21 post-test from the two groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 79-60 years- Tending to attend online seated exercise classes - Have the physical ability to attend classes.- Be able to use the facilities needed to participate in classes. Criteria for not entering: Any psychological disorder reported by the individual- History of participating in any virtual sports activity that is similar to the activity in the present study. Use of psychiatric medications before the study
Intervention groups
For the experimental group, doing sports exercises virtually through the Skype application, for 12 weeks, three days a week, time: 30-45 minutes. control group: sending videos through whatsapp (they are voluntarily, not supervised and not seated exercises(
Main outcome variables
variables: Depression, Anxiety and Stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220107053651N1
Registration date: 2022-02-28, 1400/12/09
Registration timing: retrospective

Last update: 2022-02-28, 1400/12/09
Update count: 0
Registration date
2022-02-28, 1400/12/09
Registrant information
Name
Shadi Ghadiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3253 3478
Email address
shadikio95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-01-25, 1400/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of online Floor-seated Exercise training on depression, anxiety and stress of older adults in COVID-19 epidemy
Public title
The effect of online Floor-seated Exercise training on depression, anxiety and stress of older adults during COVID-19 epidemy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 79-60 years Willingness to attend online sitting sport classes Have the physical ability to attend sitting sports classes at a distance. Have the ability to use the tools and facilities needed to participate in online sitting sport classes
Exclusion criteria:
Any psychological disorder reported by the individual History of participation in any virtual sports activities that are similar to the activities intervened in the present study. Use of psychiatric drugs before the study
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Quadruple blocking. Explanation of the method: Each sample is assigned a code and these codes are given to a person other than the researcher without the names of the samples and based on randomly assigned block allocation to the volume of 4 blocks (two assignments to the control group and two Assignment to the test group) - in such a way that the letter A will be considered for the test group and the letter B will be considered for the control group. Possible modes in the four blocks of six modes include AABB, BBAA, ABAB, BABA, ABBA, BAAB, each mode will be written on a card and the cards will be assigned the number one to six, then using the dice of the six modes One may be selected and the selected seniors will be divided into two groups based on that. This process will continue until the sample size is completed. block randomization is performed in practice using SAS statistical software. Concealment is done through the SNOSE (Sequentially Numbered, Opaque, Sealed Envelopes) method: based on the size of the research sample, a number of envelopes with aluminum wrappers (in order not to clarify the contents of the envelopes), are prepared and each of the random sequences created is recorded on a card and the cards are inside. Letter envelopes are placed in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. At the time of registration, based on the order in which eligible participants enter the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
13th floor, block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Ghods Town (West), Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-12-21, 1400/09/30
Ethics committee reference number
IR.TUMS.FNM.REC.1400.175

Health conditions studied

1

Description of health condition studied
anxiety, stress, depression
ICD-10 code
41.2
ICD-10 code description
Mixed anxiety and depressive disorder

Primary outcomes

1

Description
Anxiety score in DASS-21 questionnaire
Timepoint
assessing anxiety at the beginning and end of the research after 3 month of intervention
Method of measurement
anxiety measured by DASS-21 questionnaire

2

Description
Stress score in DASS-21 questionnaire
Timepoint
assessing Stress at the beginning and end of the research after 3 month of intervention
Method of measurement
Stress measured by DASS-21 questionnaire

3

Description
Depression score in DASS-21 questionnaire
Timepoint
assessing Depression at the beginning and end of the research after 3 month of intervention
Method of measurement
Depression measured by DASS-21 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Forming a WhatsApp group - Sending a link to provide online sessions and explanations about it and a link to the online demographic and DASS-21 questionnaires before the intervention - Completing the questionnaires online through the Pors-Line site by individuals - Providing sitting exercises online Through the Skype application by the sports expert trainer, during 12 weeks, three days a week, each session lasts for 30-45 minutes and the exercises are performed by people at the same time. Exercise with soft music including topics such as flexibility, deep breathing with up and down arm pulling, wrist grip, wrist pressure, knee support, quadriceps muscle training and mind focus - Completion of DASS-21 questionnaire after the last session by Persons
Category
Rehabilitation

2

Description
Control group: Formation of WhatsApp group - Send the link of online demographic and DASS-21 questionnaires before the intervention - Complete the questionnaires online through the Press Line site - Send only 30-45 minute short sports training videos (if you do not send this period) Video time is cut by WhatsApp, videos are sent in several videos of 10-15 minutes in a group.) Three times a week for 12 weeks in a group - Doing exercises in person if they want to (the exercises are not online and they are not supervised by the constructor and they are not mostly seated exercises so some of the participants may have trouble doing them due to their frailty)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Base No. 2
Full name of responsible person
Shadi Ghadiri
Street address
Ground floor, Arian Building, After the Clergy School, Barghan St., Azadegan Square
City
karaj
Province
Alborz
Postal code
3813716917
Phone
+98 26 3422 1644
Email
salamat2krj@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8899 2970
Fax
+98 21 8898 7382
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran School of Nursing and Midwifery
Proportion provided by this source
1
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
Shadi Ghadiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 80, Ardalan 2 Ave, Emam Reza Blvd, Azadegan Square
City
Karaj
Province
Alborz
Postal code
3149658857
Phone
0098 26 2533478
Email
shadikio95@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadi Ghadiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No80, Ardalan 2 Ave, Emam Reza Blvd
City
Karaj
Province
Tehran
Postal code
3149658857
Phone
+98 26 3253 3478
Email
shadikio95@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadi Ghadiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 80, Ardalan 2 Ave, Emam Reza Blv
City
Karaj
Province
Alborz
Postal code
3149658857
Phone
+98 26 3253 3478
Email
shadikio95@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions, or people who are also involved in industry can apply for it.
Under which criteria data/document could be used
Data analysis is allowed for scientific and statistical review, and the necessary conditions for submitting a request for access to data or documents include the provision of legal permission.
From where data/document is obtainable
Name: Shadi Ghadiri- Adress: N0.80, Ardalan 2 Ave, Emam Reza Blv- Postal Code: 3149658857- Tell: 09120427148- 02632533478- Email: shadikio95@gmail.com
What processes are involved for a request to access data/document
After sending my details and documents including personal, professional and scientific details and also the reason for the need to access project information via email to me, I will contact you at the earliest opportunity and after consulting with the project supervisor and his approval and University information will be sent to you via email. It takes a week to confirm and send the data.
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