Comparison of the effect of aerobic exercise and Xbox Kinect on blood pressure and quality of sleep and life in elderly people with hypertension
Design
This study is the double-blind randomized trial. Participants randomly divided into three groups of aerobic(15), Xbox(15), and control(15).
Settings and conduct
Participants divided into three groups of aerobic, XBox and control. In this single-blind study, the outcome assessors are blind to the details of protocols. This study was done in the Jahandidegan retirement community center. duration of exercise is 8 weeks and three times per week and 40 min for each session.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: the age of participants be 50 years and above;
Willing to participate in the study;
At least one year has passed since the diagnosis of primary hypertension by a specialist physician;
No underlying diseases like diabetes, congestive heart failure, nephropathy;
They have not participated in any other exercise program in the past six months;..
Have systolic and diastolic blood pressure;
The participants are authorized to participate in the exercise program with the permission of a specialist physician;
Having no physical limitation to attend exercise;
Exclusion Criteria:
Acute or chronic disease with documented influence on balance and gait Control (e.g., Parkinson’s disease; diabetes or peripheral neuropathy);
Joint replacement and fracture;
Use of assertive gait devices (e.g., walking canes and frames;
Missing exercise protocol more than two sessions;
Intervention groups
1. Aerobic Exercise Group: Perform aerobic exercises for 8 weeks and three days a week
2. Video Game Training Group: The players play Xbox Kinect games for 8 weeks and three days a week.
Control group: without exercise
Main outcome variables
Blood Pressure; Quality of Life; Quality of Sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040251N1
Registration date:2020-03-30, 1399/01/11
Registration timing:retrospective
Last update:2020-03-30, 1399/01/11
Update count:0
Registration date
2020-03-30, 1399/01/11
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
2019-10-22, 1398/07/30
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Xbox Kinect and aerobic exercise on blood pressure, quality of sleep, and quality life among elderly
Public title
Effects of aerobic exercises and Xbox Kinect on blood pressure, quality of sleep and life of older adults
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50 years and above
Willing to participate in the study
At least one year has passed since the diagnosis of primary hypertension by a specialist physician
No underlying diseases like diabetes, congestive heart failure, nephropathy
They have not participated in any other exercise program in the past six months
With a systolic blood pressure of 120-140 mmHg and diastolic blood pressure of 90-80 mmHg
The participants are authorized to participate in the exercise program with the permission of a specialist physician
Having no physical limitation to attend exercise
Having a sense of hearing and vision
Exclusion criteria:
acute or chronic disease with documented influence on balance and gait control (e.g., Parkinson’s disease; diabetes or peripheral neuropathy
Joint replacement and fracture
use of assertive gait devices (e.g., walking canes and frames
Missing exercise protocol more than two session
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to interventions during the pre-test and post-test.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shiraz University of Medical Science
Street address
5th Floor, Central building of Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.SUMS.REC.1398.669
Health conditions studied
1
Description of health condition studied
Blood Pressure
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis
2
Description of health condition studied
Quality of Life
ICD-10 code
Z73
ICD-10 code description
Problems related to life management difficulty
3
Description of health condition studied
Quality of Sleep
ICD-10 code
G47
ICD-10 code description
Sleep disorders
4
Description of health condition studied
Aerobic Exercise
ICD-10 code
Y93.A3
ICD-10 code description
Activity, aerobic and step exercise
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before and after intervention
Method of measurement
Aneroid Sphygmomanometer Measure
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and after intervention
Method of measurement
Quality of Life questioner
2
Description
Quality of Sleep
Timepoint
Before and after intervention
Method of measurement
Quality of sleep Questioner
Intervention groups
1
Description
Exergame Intervention group: Participants play video games with Xbox Kinect for 8 weeks and three days a week. The duration of each session is 40 minutes, including pre-workout warm-up, a video game program, and post-workout cooling.
Category
Rehabilitation
2
Description
Intervention group Aerobic Exercise: Participants do aerobic exercise for 8 weeks and three days a week. The duration of each session is 40 minutes, including pre-workout warm-up, aerobic exercise program, and post-workout cooling.
Category
Rehabilitation
3
Description
Control group without exercise or Intervention: Participants in this group will have no exercise during the study
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahandidegan Community Center in Shiraz
Full name of responsible person
Dr Mosavi
Street address
Khold Barin Park, Besaat St., Shiraz. Iran
City
Shiraz
Province
Fars
Postal code
67566-71746
Phone
+98 71 3647 5010
Email
Jahandidegandaycare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
7th floor, Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz,
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir/fa/index.html
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
60
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. Mohammadali Nazarinia
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz Geriatric Research center, Mohammad Rasul Allah Research Tower,Khalili St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
36122203-071
Fax
+98 71 3235 7282
Email
sgrc@sums.ac.ir
Web page address
http://sgrc.sums.ac.ir/fa/contact_us/index.html
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hassan Sadeghi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shiraz Geriatric Research center, Mohammad Rasul Allah Research Tower, Khalili St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3612 2203
Fax
Email
hassan.sadeghi81@yahoo.com
Web page address
http://sgrc.sums.ac.ir/fa/contact_us/index.html
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hassan Sadeghi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shiraz Geriatric Research center, Mohammad Rasul Allah Research Tower,Khalili St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3612 2203
Fax
Email
hassan.sadeghi81@yahoo.com
Web page address
http://sgrc.sums.ac.ir/fa/contact_us/index.html
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data can publish for publishing paper
When the data will become available and for how long
The study protocol will be available after publishing the paper
To whom data/document is available
everyone
Under which criteria data/document could be used
For future studies
From where data/document is obtainable
Via email
What processes are involved for a request to access data/document
The applicant needs to introduce his/her and need to explain the purpose of request as well. The information will send you as soon as possible.