Investigating the differences between 30 minutes of exergaming versus brisk walking on some physiological and psychological measures in older adults
Design
This is a single-blind, crossover study comprising of two groups, totaling 40 subjects in a single center setting
Settings and conduct
This study will be conducted in a day center for the elderly and a park. Also, the outcome assessor and data analyzer, which are two different people are blind to which person has been assigned to which group and they just work with the study population, or look at data as a whole.
Participants/Inclusion and exclusion criteria
40 Men and women aged ≥60 years are enrolled in the study. The inclusion criteria are as follows:
being able to walk with or without assistive devices for 10 meters; obtaining a score <6 (out of 15) in the Geriatric Depression Scale; obtaining a score >23(out of 30) in the Mini-Mental State Examination; responding No to all of the 7 questions in the Physical Activity Readiness Questionnaire; and the exclusion criteria are: having uncorrected vision, hearing or cardiovascular disorders; taking medications that could affect balance or orientation.
Intervention groups
There are 2 interventions in this study. One is Exergaming, which is playing video games that encourage the physical movement of the body by simulating exercise-like activities and the other intervention is walking briskly in an outdoor park. Both of the interventions are done once for 30 minutes.
Main outcome variables
Average and peak heart rate; blood pressure, and double product measurements; time spent in each heart rate zone; the rate of perceived exertion and enjoyment using Physical Activity Enjoyment Scale Questionnaire (PACSES)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151118025105N3
Registration date:2019-03-18, 1397/12/27
Registration timing:prospective
Last update:2019-03-18, 1397/12/27
Update count:0
Registration date
2019-03-18, 1397/12/27
Registrant information
Name
Sobhan Sobhani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71136271551
Email address
sobhanis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-26, 1398/03/05
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of 30 minutes of Exergaming with brisk walking in physiological and psychological measures of older adults
Public title
Comparing the effects of Exergaming with brisk walking in older adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having ≥60 years of age
Being able to walk with or without assistive devices for 10 meters
Obtaining a score <6 (out of 15) in the Geriatric Depression Scale
Obtaining a score >23(out of 30) in the Mini-Mental State Examination
Responding No to all of the 7 questions in the Physical Activity Readiness Questionnaire
Exclusion criteria:
Having uncorrected vision, hearing or cardiovascular disorders
Taking medications that could affect balance or orientation
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Each participant is randomized to an AB or BA group, therefore the participant is used as his or her own control. Participants in the AB group receive intervention A (Brisk Walking) followed by intervention B (Exergaming) and the ones in the BA group receive intervention B (Exergaming) followed by intervention A (Brisk Walking).
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor and data analyzer, which are two different people are blind to which person has been assigned to which group and they just work with the study population, or look at data as a whole.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.SUMS.REHAB.REC.1397.007
Health conditions studied
1
Description of health condition studied
Ageing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average heart rate
Timepoint
During the intervention
Method of measurement
Heart rate monitor
2
Description
Peak Heart Rate
Timepoint
During the Intervention
Method of measurement
Heart Rate Monitor
3
Description
Rate of Perceived Exertion
Timepoint
Immediately after the Intervention
Method of measurement
10-Point Rate of Perceived Exertion Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before and immediately after the intervention
Method of measurement
Sphygmomanometer
2
Description
Double product
Timepoint
Immediately after the intervention
Method of measurement
Multiplying systolic blood pressure number by heart rate over 1 minute
Intervention group AB- Brisk walking first and then Exergaming: In this group, the participant will first walk briskly for 30 minutes in a park area. Before the start of intervention, their resting blood pressure will be measured and then their heart rate will be consistently recorded throughout the walking session. Also the rest of research valuables like the Rate of Perceived Exertion Scale and the Physical Activity Enjoyment Scale Questionnaire will be measured/filled after the intervention. After 1 week, these participants will perform the second intervention, which is playing Exergames for 30 minutes. In this session, all of the measurements will be taken just like the previous session.
Category
Other
2
Description
Intervention group BA- Exergaming first and then brisk walking: In this group, the participant will be first playing Exergames for 30 minutes. Before the start of intervention, their resting blood pressure will be measured and then their heart rate will be consistently recorded throughout the Exergaming session. Also the rest of research valuables like the Rate of Perceived Exertion Scale and the Physical Activity Enjoyment Scale Questionnaire will be measured/filled after the intervention. After 1 week, these participants will perform the second intervention, which is walking briskly for 30 minutes in a park area. In this session, all of the measurements will be taken just like the previous session.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Jahandidegan Center
Full name of responsible person
Sobhan Sobhani
Street address
Kholdebarin Park, Beesat St., Shiraz
City
Shiraz
Province
Fars
Postal code
7183654876
Phone
+98 71 3647 5010
Email
sobhanis@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University
Full name of responsible person
Dr. Farhad Daryanoosh
Street address
Shiraz University, Eram Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7196484334
Phone
+98 71 3613 4634
Email
Daryanoosh@Shirazu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sobhan Sobhani
Position
Assistant Professor, PT, PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences , 1st Abiverdi Street , Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Fax
Email
SobhaniS@Sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sobhan Sobhani
Position
Assistant Professor, PT, PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences , 1st Abiverdi Street , Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Fax
Email
SobhaniS@Sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sobhan Sobhani
Position
Assistant Professor, PT, PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences , 1st Abiverdi Street , Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Fax
Email
SobhaniS@Sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data of the participant alone is useless.
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of primary outcomes will be shared.
When the data will become available and for how long
two months after the publication of the results.
To whom data/document is available
academic researchers
Under which criteria data/document could be used
Once accessed, individuals have the right to use the study protocol for rehabilitation purposes.
From where data/document is obtainable
Reza Sayar will be responsive through email.
Rez.Sayar@gmail.com
What processes are involved for a request to access data/document
After receiving the request and mentioning the reasons for the request, the data will be answered within a maximum of one month.