Investigation the effect of Qigong on depression, anxiety, stress and activity of daily living in elderly referring to comprehensive health center in Rafsanjan 2020
If doing gong exercise can reduce the level of depression, anxiety, stress and increase daily activity in the elderly, it can be suggested as a practical and low-cost method.
Design
Clinical trial with control group, no blinding, randomized
Settings and conduct
Elderly people referring to Rafsanjan Comprehensive Health Centers will be selected in the first session of training exercises in person and then a DVD of exercises will be provided to people and people will do exercises for 8 weeks, 3 times a week for 30 minutes. The statistician does not know which people are in the intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: elderly people 60 years and older; no musculoskeletal problems and mental illness.
Exclusion criteria: start treatments for depression and anxiety; perform relaxation techniques
Intervention groups
Qi Gong Mental-Physical Exercise involves slow focused movements, coordinated with breathing and cognitive skills. This exercise creates more peace and integration of mind and body. The intervention group will perform exercises for 8 weeks, 3 times a week for 30 minutes and the control group will have their daily activities.
Main outcome variables
Depression; anxiety; stress and daily activities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N24
Registration date:2020-10-17, 1399/07/26
Registration timing:prospective
Last update:2020-10-17, 1399/07/26
Update count:0
Registration date
2020-10-17, 1399/07/26
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of Qigong on depression, anxiety, stress and activity of daily living in elderly referring to comprehensive health center in Rafsanjan 2020
Public title
Investigation the effect of Qigong on depression, anxiety, stress and activity of daily living in elderly referring to comprehensive health center in Rafsanjan 2020
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people over 60 years
Ability to use a smartphone
No depression, anxiety, stress disorder when undergoing medication from 3 months before the study
No disability
Interested in participating in research
No Parkinson's and Alzheimer's disease
Do not engage in any kind of relaxation technique
No sports ban
No drug abuse
Lack of musculoskeletal problems
Exclusion criteria:
Reluctance to continue collaborating in this study
Do not do exercises for 3 sessions or more
Performing relaxation techniques such as massage therapy or acupuncture
Diseases such as myocardial infarction, stroke, late stages of cancer, organ transplantation
Initiated taking antidepressants, anxiety, stress drugs
Age
From 60 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
According to the simple randomization, elderly were divided into two group 35 person, the intervention group and the control group. Elderly will divided into two groups of 35 people, A and B, based on a table of random numbers, and finally, groups A and B will divided into intervention and control groups based on the lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Individuals will be divided into two groups of intervention and control, and the intervention group will perform Qi Gong exercise,then will be studied and compared the effect of Qi Gong exercise on the level of depression, anxiety, stress and activity of daily living between the two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Rafsanjan University of Medical Sciences
Street address
School of Nursing and Midwifery, Nurse Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2020-10-04, 1399/07/13
Ethics committee reference number
IR.RUMS.REC.1399.159
Health conditions studied
1
Description of health condition studied
Depression in elderly
ICD-10 code
F32.9
ICD-10 code description
Depression
2
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression
Timepoint
Before, one month and 2 months after intervention
Method of measurement
DASS21 questionnaire
2
Description
Anxiety
Timepoint
Before, one month and 2 months after intervention
Method of measurement
DASS21 questionnaire
3
Description
Stress
Timepoint
Before, one month and 2 months after intervention
Method of measurement
DASS21 questionnaire
4
Description
Activity of daily living
Timepoint
Before, one month and 2 months after intervention
Method of measurement
ADL& IADL questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first session will be given to the necessary training for the companies in the presence of the instructor, and then the training exercises DVD will be provided to you. The members of the intervention group are added to the Watts group and a photo of the exercises in the group is sent to the individuals. Others are asked to do the exercises 3 times a week for 30 minutes to 8 weeks. Then follow up the phone to do the exercises
Category
Treatment - Other
2
Description
Control group: : The first session, which will be held at a predetermined time and date in accordance with health protocols and will be completed by individuals after attracting the participants' opinion on researching the relevant questionnaires.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers in Rafsanjan
Full name of responsible person
Dr. Tayebeh mirzaei
Street address
Jomhory street, Parastar blv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamsinezadeh
Street address
Emam َ Ali blvd.
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3131 5075
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayyebeh Mirzaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebe Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34255900
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available