The purpose of the study is to compare effect of exergame, strength training and mixed of them on knee proprioception, balance and quality of life among elderly
Design
A randomized clinical trial study, single-blind, Factorial, 56 elderly randomized to 3 intervention groups and a control group through web-based randomization
Settings and conduct
Participants are divided into four groups: Balance training, exergame, the combination of balance, and exergame, and control groups. This study is single-blind that the outcome assessor is blind to interventions. This study will be conducted in the neighborhood of Tehran Municipality, District 7, and the participants will be explained the importance of protocol. The protocols are 8 weeks and three 40-minute sessions per week.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 65 years of age and older with the ability and mobility to join the group training sessions. Able to walk without an Assistive Device. Exclusion Criteria: Have acute or chronic disease with influence on balance control (e.g., Parkinson’s disease; diabetes or peripheral neuropathy).
Who participated in regular exercise programs in the last 6th month.
Intervention groups
Balance training (intervention 1): Balance training is done for 8 weeks and three days a week 2. Video game training (intervention 2): Participants play Xbox Kinect games for 8 weeks and three days in the week. 3 combinations of both (intervention 3): the combination of Xbox games and balance training for 8 weeks and three days a week. 4. Control group: There is no activity during the 8 weeks of the training program.
Main outcome variables
Knee proprioception, Balance, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040251N4
Registration date:2021-09-14, 1400/06/23
Registration timing:registered_while_recruiting
Last update:2021-09-14, 1400/06/23
Update count:0
Registration date
2021-09-14, 1400/06/23
Registrant information
Name
Hassan Sadeghi
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8001
Email address
hassan.sadeghi81@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-10-04, 1400/07/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of exergame and balance training on knee proprioception, balance and quality of life among older adults. Randomized control trial
Public title
Comparison of exergame and balance exercises on balance and knee proprioception of the elderly
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
65 years of age and older with the ability and mobility to join the group training sessions.
Able to walk without an Assistive Device.
Exclusion criteria:
Have acute or chronic disease with influence on balance control (e.g., Parkinson’s disease; diabetes or peripheral neuropathy).
Who participated in regular exercise programs in the last 6th month.
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized into one of four groups (Three intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.
Activity, other involving muscle strengthening exercises
5
Description of health condition studied
Quality of Life
ICD-10 code
Z73
ICD-10 code description
Problems related to life management difficulty
Primary outcomes
1
Description
Knee Proprioception test
Timepoint
immediately before intervention; immediately after intervention and 3 month after intervention
Method of measurement
Biodex Isokinetic Dynamometer
Secondary outcomes
1
Description
Static Balance
Timepoint
immediately before intervention; immediately after intervention and 3 month after intervention
Method of measurement
Single leg Stance test
2
Description
Quality of Life
Timepoint
immediately before intervention; immediately after intervention and 3 month after intervention
Method of measurement
Quality of Life questioner
Intervention groups
1
Description
Intervention group1: In this group, the Exergaming training sessions are done by the Xbox Kinect, which uses Console and Kinect Sensors. The sensor is an infrared camera that diagnoses the position and movements of the player automatically and records the various activities of the participants. By selecting the games, the person is placed in front of the infrared camera and performs the movements based on the movements performed by the console. The experiment is carried out three times per week and continues for eight weeks. Each session will be 40 minutes, which includes warming up and cooling down before and after the exercise.
Category
Rehabilitation
2
Description
Intervention group 2: Three times per week in eight weeks of balance exercises. These exercises’ programs are including activities to improve balance and lower limb muscle proprioception. Such exercises are the single leg stance with eyes open and closed, then standing on the unstable surface. The duration of each session is 40 minutes, including warming up and cooling down before and after the exercise sessions.
Category
Rehabilitation
3
Description
Intervention group 3: Participants of this group perform two types of exercises including exergame and balance in each session three times per week in eight weeks. Half of the training session time is assigned to exergame (intervention one) and the other half is devoted to balance exercises (intervention two). Each session, which includes warming up and cooling down before and after the exercise, lasts for 40 minutes.
Category
Rehabilitation
4
Description
Control group 1: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Department of Municipality District 7
Full name of responsible person
Miss Maryam Priyaie
Street address
Gorgan Neighborhood House, Tavakoli Park, Shahid Madani St,
City
Tehran
Province
Tehran
Postal code
1615786614
Phone
+98 21 7754 0432
Email
info.region7@tehran.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Jamshid Shanbehzadeh
Street address
Vice-Chancellor for Research and Technology. No. 43. South Mofatteh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 2222 8001
Fax
Email
Jamshids@khu.ac.ir
Web page address
https://research.khu.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi University
Proportion provided by this source
50
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
Kharazmi University
Full name of responsible person
Dr. Hassan Sadeghi
Position
Postdoctoral Research
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Email
Hassan.sadeghi81@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr. Hassan Sadeghi
Position
Postdoctoral Research
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Email
Hassan.sadeghi81@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr. Hassan Sadeghi
Position
Postdoctoral Research
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Email
Hassan.sadeghi81@yahoo.com
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