Comparison of the effect of Otago exercises and chair squat under supervision at home on the fear of falling and the quality of life of the elderly referring to Rafsanjan comprehensive health centers in 2023.
Determining the comparative effect of the effect of Otago exercises and chair squat under supervision at home on the fear of falling and the quality of life of the elderly.
Design
120 eligible seniors will be divided into 3 groups (two intervention groups and one control group) using a simple random division method using a random number table, and the type of intervention will be determined again by random division.
Settings and conduct
The intervention will done on elderly with fear of falling and low quality of life referring to Rafsanjan health centers. Both interventions will done at home by Individuals.
Participants/Inclusion and exclusion criteria
Entry criteria: over 60 years old, score of 10 from the SAFFE questionnaire, low average quality of life based on the SF-36 questionnaire, not having a severe hearing and vision problems and physical and mental problems that prevent movement, not having to diseases and the use of drugs that cause balance disorders and fear of falling, complete mastery of the Persian language, not living in Nursing home or other institutions, not having an activity prohibition order from a doctor, not having a disability.Exit criteria: unwillingness to continue cooperation, not doing more than 3 sessions of training, suffering from physical diseases that prevent full participation in training.
Intervention groups
Both intervention groups with one of their family members participates in an orientation session and the protocol of each exercise in each group is taught by the researcher using handbook and videos. then for 8 weeks, 3 sessions of 45 minutes per week at home they exercises according to the training method. control group do their usual daily activities. Fear of falling and quality of life of all participants in the study will be measured before and one month after the end of the intervention.
Main outcome variables
Fear of falling, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N29
Registration date:2023-07-21, 1402/04/30
Registration timing:prospective
Last update:2023-07-21, 1402/04/30
Update count:0
Registration date
2023-07-21, 1402/04/30
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
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Otago exercises and chair squat under supervision at home on the fear of falling and the quality of life of the elderly referring to Rafsanjan comprehensive health centers in 2023.
Public title
Comparison of the effect of Otago exercises and chair squat under supervision at home on the fear of falling and the quality of life of the elderly.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 60 years old
Obtaining an average score of 10 from the SAFFE questionnaire
Having a low average quality of life based on the SF-36 questionnaire
Not having a severe hearing problem
Not having severe vision problems
Not having physical and mental problems that prevent movements
Not suffering from diseases such as stroke, dementia, multiple sclerosis, orthopedic problems, as well as taking medications that cause balance disorders and fear of falling (obtaining information through interviews and examining the health status of the elderly)
Complete mastery of the Persian language
Not living in a nursing home or other institutions
Not having an activity prohibition order from the doctor
No having disability
Exclusion criteria:
History of spine fracture and vertebral and orthopedic problems
Having a regular exercise program in the previous 6 months
Having health problems affecting doing exercises at home such as heart disorder, brain disorder, dyspnea, arrhythmia
Chronic use of knee braces, crutches, walkers and wheelchairs
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the samples, the data will be divided into 3 groups A, B, and C according to age and sex, in such a way that the first data in one of the 3 groups will be divided by a simple random method and using the "Random allocation software" are selected and and in the next 2 groups, the data is allocated in the same way based on the software. After allocating the data equally to 3 groups, treatment methods were written on 3 separate sheets and a method will be assigned to each group by lottery, and the intervention groups of Otago exercise and Chair Squat exercise and the Control group will be determined.
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
Research Ethics 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
2023-07-19, 1402/04/28
Ethics committee reference number
IR.RUMS.REC.1402.051
Health conditions studied
1
Description of health condition studied
Fear of falling
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Quality of Life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
elderly Fear of falling
Timepoint
All participants will complete the SAFFE fear of falling questionnaire before and one month after the end of the intervention.
Method of measurement
SAFFE fear of falling questionnaire
2
Description
elderly quality of life
Timepoint
All participants will complete the SF-36 quality of life questionnaire before and one month after the end of the intervention.
Method of measurement
SF-36 Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Otago exercise intervention group with one of their family members participates in an orientation session and the exercise protocol is taught by the researcher using training handbook and videos, and at the end of the session, all the elderly are assessed one by one in terms of correct performance of exercises. Then, for 8 weeks, 3 sessions a week and each session lasts 45 minutes at home, they do Otago exercises according to the training method. During the study, all the participants are monitored through virtual groups in which the elderly themselves or one of their family members who attended the briefing session are members, as well as telephone follow-ups, and they can raise their questions and problems. Each session exercises is reminded and monitored, and if possible, training videos of the exercises are also shared for them.
Category
Treatment - Other
2
Description
Intervention group: The Chair squat exercise intervention group with one of their family members participates in an orientation session and the exercise protocol is taught by the researcher using training handbook and videos, and at the end of the session, all the elderly are assessed one by one in terms of correct performance of exercises. Then, for 8 weeks, 3 sessions a week and each session lasts 45 minutes at home, they do Chair squat exercises according to the training method. During the study, all the participants are monitored through virtual groups in which the elderly themselves or one of their family members who attended the briefing session are members, as well as telephone follow-ups, and they can raise their questions and problems. Each session exercises is reminded and monitored, and if possible, training videos of the exercises are also shared for them.
Category
Treatment - Other
3
Description
Control group: In the control group with the same conditions as the intervention groups, there is no intervention and they continue their usual daily activities.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan comprehensive health centers
Full name of responsible person
Dr.Tayebeh Mirzaei, KHalil Abadi
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Reza Vazirinejad
Street address
Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3131 5075
Email
rvazirinejad@yahoo.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.Tayebeh Mirzaei, KHalil Abadi
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
Fax
+98 34 3425 8497
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, KHalil Abadi
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
Fax
+98 34 3425 8497
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.Tayebeh Mirzaei, KHalil Abadi
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