comparative study of planter reflexology and chair-based-exercise on the fear of falling and self-efficacy in the elderly
Design
A randomized clinical trial was conducted in two intervention groups without control group 50 elderly people randomly assigned randomly into two equal groups and randomized interventions for each research unit.
Settings and conduct
A randomized clinical trial was conducted in two intervention groups without control group. 50 elderly people divided of Student Health Center, Neshat's daily rehabilitation center, Mashhad University of Medical Sciences Acupuncture Center, are randomly divided into two intervention groups.12 reflexology sessions the sole of the foot. 12 sessions of chair exercises in the other group, in groups of 10 people Done. Fear of falling and self-efficacy in fall Completed before and after intervention.
Participants/Inclusion and exclusion criteria
Entry requirements: age 60 to 85 years; having informed consent
Non entry requirements: having history of acute musculoskeletal disorders
Intervention groups
12 sessions of reflexology the sole of the foot individually for each research sample (weekly 2 times and each session for 30 minutes)
12 sessions of chair exercises in the other group, in groups of 10 people for research sample (weekly 2 times and each session for 60 minutes).
Main outcome variables
Fear of falling , Self-efficacy in the fall
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180303038928N1
Registration date:2018-05-18, 1397/02/28
Registration timing:registered_while_recruiting
Last update:2018-05-18, 1397/02/28
Update count:0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Leyla Mohammadabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3760 6184
Email address
mohammadabadiL941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of planter reflexology and chair-based-exercise on the fear of falling and falls self-efficacy in the elderly
Public title
planter reflexology and chair-based-exercise on the fear of falling and falls self-efficacy in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 60-85 years
Earning a score higher than 32 from the FESI Fall Inventory
Score less than 8 of self-efficacy moderated questionnaire in MFES fall
Earn more than 7 score from the AMT Cognitive Questionnaire
Have written consent to participate in the study
Exclusion criteria:
Having history of acute musculoskeletal disorders
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Peoples are divided into two groups by random allocation according to the random allocation table.
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
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Dneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-03-01, 1396/12/10
Ethics committee reference number
IR.MUMS.REC.1396.346
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
Self-efficacy in the fall
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of falling
Timepoint
Before the intervention and 45 days after the intervention
Method of measurement
Fall Efficacy Scale International
2
Description
Self-efficacy in the fall
Timepoint
Before the intervention and 45 days after the intervention
Method of measurement
Modifive fall efficacy scale
Secondary outcomes
empty
Intervention groups
1
Description
"intervention group 1": Implementation of 12 sessions of reflexology the sole of the foot in the reflexology group individually for each unit of research (2 times in week and each session for 30 minutes).
Category
Prevention
2
Description
"intervention group 2 ": 12 sessions of Chair exercises in the other group for research units (2 times in week each session for 60 minutes)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Student Health Center
Full name of responsible person
Leyla Mohammadabadi
Street address
Student Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
-
Phone
+98 51 3893 2322
Email
mohammadabadil941@mums.ac.ir
2
Recruitment center
Name of recruitment center
Neshat daily rehabilitation center
Full name of responsible person
Leyla Mohammadabadi
Street address
Kalantari Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
-
Phone
+98 51 3893 2322
Email
mohammadabadil941@mums.ac.ir
3
Recruitment center
Name of recruitment center
Acupuncture Center, University of Mashhad
Full name of responsible person
Leyla Mohammadabadi
Street address
Taghi Abad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
-
Phone
+98 51 3802 2500
Email
mohammadabadil941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
-
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Leyla Mohammadabadi
Position
Graduate Student, geriatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Mohammadabadil941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir reza Salehmoghaddam
Position
Professor science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Salehmoghaddamar@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Leyla Mohammadabadi
Position
Graduate Student, geriatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mohammadabadil941@mums.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
Not applicable
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