Evaluation of the effect of home-based balance training exercise on balance indices of older adults
Design
Two parallel group randomized by Permuted block randomization, designed for 50 elderly and blinded outcome
Settings and conduct
It is a randomized clinical trial that is conducted in Imam Reza Army Hospital in Tehran in 1401. In this study, 50 elderly people who refer to Imam Rezai Hospital in Tehran in 1401 are randomly selected. After giving the necessary explanations, a signed written consent is obtained. Then the patients are put through the Timed up and go test, the 6 Minute Walk Test. Then patients are placed in one of two control groups or experimental groups. The control group walks thirty minutes a day, five days a week. The experimental group is trained in motor control exercises first.hen, in addition to walking five days a week for 12 weeks, they also do exercises three times a week at home. Before the intervention, immediately after the completion of the treatment sessions and three months after the completion of the sessions, the patients are examined in terms of the mentioned factors.
Participants/Inclusion and exclusion criteria
elderly more than 60 years old
independent ambulation
use of cane or other assistive devices
established Diabetes mellitus
established neurologic disease
severe cardiovascular disease
severe peripheral vascular disease
any disease preventing participation in more than 30% of training sessions
Intervention groups
Intervention group: walking 30 minutes per day, 5 days per week plus motor control exercise at home, 3 times per week for 12 weeks
Control group: walking 30 minutes per day, 5 days per week
Main outcome variables
Timed up and go test
6 minutes walking test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220620055228N1
Registration date:2022-08-30, 1401/06/08
Registration timing:prospective
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Zahra Ahmadi Mottaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 0059
Email address
zahra.ahmadimottaghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of home-based balance training exercise on balance indices of older adults
Public title
Evaluation of the effect of home-based balance training exercise on elderly's balance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly more than 60 years old
Independent ambulation
Exclusion criteria:
Use of cane or other assistive devices
Established Diabetes mellitus
Established neurologic disease
Severe cardiovascular disease
Severe peripheral vascular disease
Any disease preventing participation in more than 30% of training sessions
Unwillingness to continues
Not having at least two regular physical activity sessions per week
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
First, blocks of 6 are prepared, each block includes 3 patients for the control group and 3 patients for the intervention group. For example, in one block, the first three patients may be placed in the control group and the next three patients in the intervention group. And in another block, the patients may be divided one by one.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the intervention and control groups have an exercise program, but they do not know the difference between the program.
The statistical analyst does not know the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
AJA university of medical science, Etemadzade Ave, West Fatemi Blvd, Amirabad
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2022-06-20, 1401/03/30
Ethics committee reference number
IR.AJAUMS.REC.1401.003
Health conditions studied
1
Description of health condition studied
elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Timed up and go test
Timepoint
Before intervention, just after intervention, 3 months later
Method of measurement
Time required for standing, walking 3 meters, returning, go back and sitting
2
Description
6 minutes walking test
Timepoint
Before intervention, just after intervention, 3 months later
Method of measurement
Distance of walking in 6 minutes
Secondary outcomes
empty
Intervention groups
1
Description
Control group: walking 30 minutes per day, 5 days per week
Category
Lifestyle
2
Description
Intervention group: walking 30 minutes per day, 5 days per week plus motor control exercise at home, 3 times per week for 12 weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Zahra Ahmadi Mottaghi
Street address
Imam Reza hospital, Etemadzadeh Ave, West Fatemi Blvd, Amirabad
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
zahra.ahmadimottaghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
رضا مساعد
Street address
AJA university of medical science, Etemadzade Ave, West Fatemi Blvd, Amirabad
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
zahra.ahmadimottaghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?