Study of symmetry in cross transfer on whole body function after a period of rehabilitative training in elderly women
Design
clinical trial with a control group, with parallel groups, double-blind, using simple randomization with lottery method, on 45 participants
Settings and conduct
The research of quasi-experimental with a per-test-post-test design.Upper and lower body strength tests using digital dynamometer, body composition using Akren BIA101 BIVA, gait performance with optogate device and to evaluate blood pressure and resting heart rate from digital sphygmomanometer will be measured in the laboratory of Bojnourd University. To determine the performance of functional tests will be used. double blinding, First, some general information about how to perform the training and testing will be given to the three groups. In order to assign individuals to groups, researchers and participants no information will be the functional characteristics of individuals.
Participants/Inclusion and exclusion criteria
Elderly women inclusion criteria:Having no regular training over the past six months, Healthy women 55 years and older non-Exclusion criteria: Having joint and physiological problems, Having a history of falling
Intervention groups
45 healthy and inactive elderly women will be divided into three groups: Two training groups (30 people) will perform a strength and balance rehabilitative exercise program three times per week. Meanwhile, the control group (15 people) will be without training.
Main outcome variables
Symmetry in whole body function, Upper and lower body
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201030049193N2
Registration date:2021-06-26, 1400/04/05
Registration timing:prospective
Last update:2021-06-26, 1400/04/05
Update count:0
Registration date
2021-06-26, 1400/04/05
Registrant information
Name
Mahdi Hosseinzadeh
Name of organization / entity
Sport Sciences Research Institute of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 7714 6478
Email address
metti@ssrc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of symmetry in cross transfer on whole body function after a period of rehabilitative training in elderly women
Public title
asymmetry in cross transfer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having no regular training over the past six months
Healthy women 55 years and older
Exclusion criteria:
Having joint and physiological problems
Having a history of falling
Age less than 55 years
Age
From 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
From the women's participating in the study, three groups will be selected by the available method and the block randomization method will be used to create a random sequence. In this method, blocks of 6 all possible combinations (8 modes) are created, then these blocks are numbered and randomly selected and placed one after the other, and thus, participants will be assigned two groups A and B (intervention), group C (control).
Blinding (investigator's opinion)
Double blinded
Blinding description
To create blind, double - blind, Individuals will be divided into two groups of strength and balance rehabilitative intervention intervention with one leg (dominant and non-dominant) and a control group without training. First, some general information about how to perform the training and testing will be given to the three groups. In order to assign individuals to groups, researchers and participants no information will be the Functional characteristics of individuals.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Reseatch Institute
Street address
No. 3,Fifth, Mir Emad St.,Ostad Motahari St
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.SSRC.REC.1399.013
Health conditions studied
1
Description of health condition studied
Symmetry in transfer, Symmetry in limbs
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Strength lower body, hamstring and quadriceps muscles
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Digital dynamo-meter device made in Iran, 30 second chair stand test
2
Description
Strength upper body, Biceps muscles
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Digital dynamo-meter device made in Iran, 30 second arm Curl Test
3
Description
Static balance
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Stork balance test, balance berg, Sharpend Romberg with eyes open and closed, static balance test
4
Description
Dynamic balance
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Star Excursion Balance Test, Time Get up and go, Tandem walking
5
Description
Proprioception Knee joint and elbow joint
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Plastic goniometers By accurately measuring 1 degree
6
Description
Functional Gait Assessment
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Optogait With a frequency of 1000 Hz and an accuracy of 1 cm Made in Italy, 10m walk test
7
Description
Pain score
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Visual Analogue Scale, Timed 10-stair climb and descent
8
Description
Blood pressure
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Digital pressure gauge
9
Description
Anthropometric indices such as around the arm, forearm, thigh, leg
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Weight measurement using a digital scale made in China with an accuracy of 100 grams. Measure the circumference of the arm, forearm, thigh, leg using a tape meter made in Iran with an accuracy of 0.1 cm. Body composition using the BIA101 BIVA Akren body composition machine made in Italy
10
Description
resting heart rate
Timepoint
Before the start of the study, during the study (Eighth week) and then after the end of twelve weeks with or without applying the treatment.
Method of measurement
Digital pressure gauge
Secondary outcomes
empty
Intervention groups
1
Description
first intervention group: Consisting of 15 people and implementing a rehabilitative program 3 sessions per week and each session 45-60 minutes of training with the dominant leg And by observing the principle of overload will be for 12 weeks. This program consists of three parts: warm-up lower limbs (part I), 10 minutes of stretching movements and a variety of steps in two directions, including (wedding march), knee-high walking, side ways walking, (Sami tandem walk) Walking in one direction and in a straight line, walking in one direction so that the hind toe touches the heel of the front foot, walking on the toe and on the heel (Rogers et al., 2012). Strength and balance training for the hamstrings and quadriceps dominant leg (Part II), strength exercises sitting on a chair and standing with a focus on strengthening the quadriceps and hamstrings dominant leg. The first three weeks, 3 sets with 10 repetitions of training based on the individual's weight and without external resistance, the second three weeks, 3 sets with 10 repetitions of two colors (green, purple) stretch bands as external resistance, the third three weeks added to the number of repetitions and training with cache (3 sets with 15 repetitions), three fourth weeks added to the number of courses (4 sets with 15 repetitions). After strength training, subjects will engage in dynamic and static balance exercises with the dominant leg , and the number of repetitions in dynamic balance training and standing time in static balance will be increased every three weeks; Cool down (part III), 10 minutes walking, standing and sitting stretching movements.
Category
Rehabilitation
2
Description
second intervention group: consisting of 15 people and implementing a rehabilitative program 3 sessions per week and each session 45-60 minutes of training with the non-dominant leg And by observing the principle of overload will be for 12 weeks. This program consists of three parts: warm-up lower limbs (part I), 10 minutes of stretching movements and a variety of steps in two directions, including (wedding march), knee-high walking, sideways walking, (Sami tandem walk) Walking in one direction and in a straight line, walking in one direction so that the hind toe touches the heel of the front foot, walking on the toe and on the heel (Rogers et al, 2012). Strength and balance exercises for the hamstrings and quadriceps non-dominant leg (Part II), strength training sitting on a chair and standing with a focus on strengthening the quadriceps and hamstrings non-dominant leg. The first three weeks, 3 sets with 10 repetitions of training based on the individual's weight and without external resistance, the second three weeks, 3 sets with 10 repetitions of two colors (green, purple) stretch bands as external resistance, the third three weeks added to the number of repetitions and training with cache (3 sets with 15 repetitions), three fourth weeks added to the number of courses (4 sets with 15 repetitions). After strength training, subjects will engage in dynamic and static balance exercises with the non-dominant leg, and the number of repetitions in dynamic balance exercises and standing time in static balance will be increased every three weeks; Cool down (part III), 10 minutes walking, standing and sitting stretching movements.
Category
Rehabilitation
3
Description
Control group: Consists of a group of 15 people and they will be engaged in their daily and former activities for twelve weeks.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Univercity of Bojnord
Full name of responsible person
Mahta Sardroodian
Street address
4th Km along the Road to Esfarayen, Bojnord, North Khorasan
City
Bojnord
Province
North Khorasan
Postal code
9453155111
Phone
+98 58 3220 1000
Fax
+98 58 3228 4605
Email
Info@ub.ac.ir
Web page address
https://ub.ac.ir/en/home
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Univercity of Bojnord
Full name of responsible person
Hasan Sajjadi
Street address
4th Km along the Road to Esfarayen, Bojnord, North Khorasan
City
Bojnord
Province
North Khorasan
Postal code
9453155111
Phone
+98 58 3220 1000
Fax
+98 58 3228 4605
Email
Info@ub.ac.ir
Web page address
https://ub.ac.ir/en/home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is a plan to make this available
Title and more details about the data/document
We share data files including personal information and data related to pre-test and post-test in a coded and unanimous folder by the person in charge, Dr. Mehdi Hosseinzadeh, on the website of Bojnord University.
When the data will become available and for how long
Start the access period as soon as the results are published
To whom data/document is available
It will be available to all research groups as well as all other people who are interested
Under which criteria data/document could be used
The data can be used for further studies as well as in all research groups, and any kind of research analysis and use is allowed on the data, and under the conditions that the person use it should refer to us (the paper published), this data will be provided to them.
From where data/document is obtainable
Refer to the person responsible for answering Dr. Mehdi Hosseinzadeh: Address: No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran, Iran Sport Science Researcher Institute Postal Code 1587958711 Email: metti@ssrc.ac.ir Phone: 009877146478 : 00988739092
What processes are involved for a request to access data/document
The applicant will send his/her application to the e-mail address of Dr. Mehdi Hosseinzadeh (metti@ssrc.ac.ir) and Dr. Hosseinzadeh will provide the information to his/her after the necessary checks.