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The effect of single and dual task balance training on balance, cognitive function and fear of falling retired recovered from COVID-19

Protocol summary

Study aim
Investigate the effect of single and dual task balance training on, fear of falling, cognitive function and balance of older adults who recovers from COVID 19
Design
A semi-experimental clinical trial with a control group with parallel groups, two-way blind randomized on 45 patients. Rand function of Excel software was used for randomization.
Settings and conduct
After achieving the entry criteria, people were divided into three groups of single and dual task balance training and control based on the score inTime up and go test. The experimental groups perform exercises for 4 weeks and a total of 12 sessions. The dual task training group performed cognitive tasks at the same time as balancing tasks. All groups in the pre-test and post-test stage only performed balance tasks without cognitive tasks at the same time.
Participants/Inclusion and exclusion criteria
The criteria for entering the research are at least 60 years old, being able to read and write, living in Kerman, and being able to walk a distance of 10 meters without aids. The severity of COVID 19 in these people is at level 1 whose symptoms include headache, loss of sense of smell, cough, fever, chest pain and fatigue. And those who were severely affected by this disease were not selected in this research. Exclusion criteria include: psychosis and acute psychiatric conditions, progressive psychiatric diseases such as MS and Parkinson's, scoring less than 24 on the MMSE, visual and auditory impairment
Intervention groups
The experimental groups performed the exercises under conditions with and without dual task, while the participants in the control group only participate in the pre-test and post-test
Main outcome variables
Fall prevention; Improve balance; Reduce age-related cognitive disorders; Improvement of the psychological factor associated with falling; Reducing the side effect of Covid 19.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221207056741N1
Registration date: 2023-05-01, 1402/02/11
Registration timing: retrospective

Last update: 2023-05-01, 1402/02/11
Update count: 0
Registration date
2023-05-01, 1402/02/11
Registrant information
Name
Hesam Iranmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 4885
Email address
hesam.iranmanesh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-25, 1401/11/05
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of single and dual task balance training on balance, cognitive function and fear of falling retired recovered from COVID-19
Public title
The effect of single and dual task balance training on balance dependent factors of older adults recovered from COVID-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aging between 60-80 Ability to stand for a minute and walk for 10 for 10 minutes without and aids and stick Normal vision Being able to read and write Being healthy or not having used any balance affecting medicine Having tested positive in COVID19 and being hospitalized in a recent year Living in Kerman city Scoring more than 24 points at Standardized Mini-Mental State Examination
Exclusion criteria:
Progressive neurological condition such as Parkinson disease, or Alzheimer Existence of cardiovascular disease (myocardial infarction, congestive heart disease, uncontrolled blood pressure, hypotension, decreased heart rate) Significant visual and auditory impairments History of depression, anxiety or other mental disorders Having a history of rheumatic and metabolic diseases such as rheumatoid arthritis, diabetes Existence of severe deformities of the joints of the lower limbs or trunk, such as severe Kyphosis or scoliosis, severe osteoarthritis of the hip and knee joints. Having a history of balance disorder and frequent positional dizziness Having a history of joint replacement in the lower limb Consuming alcohol, sedatives or any type of special medicine that affects balance or cognitive status. High inflammation of lungs up to 40% due to COVID 19
Age
From 60 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All of the participants in this investigation are divided in tow experimental groups and a control group. they will be participated in a per-test, training and post-test in separate days and they will not be in communication with each other. Therefor there would be a one-way blinding
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatullah University of Medical Sciences
Street address
MollaSadra street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2023-02-25, 1401/12/06
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.126

Health conditions studied

1

Description of health condition studied
COVID 19
ICD-10 code
U09.9
ICD-10 code description
Post Covid 19 Condition

Primary outcomes

1

Description
Berg Balance scale to measure functional balance status in elderly people.
Timepoint
In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session.
Method of measurement
This test consists of 14 sub-tests that will be administered by the examiner and higher scores in this test indicate higher functional balance. To perform this test, very simple devices such as a timer, a ruler, and a step with a height of 18 to 20 cm will be used.

2

Description
People's reaction time in serial reaction time software to measure cognitive performance in elderly people.
Timepoint
In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session.
Method of measurement
In this test, the person must respond to the stimuli that are presented in a specific and predetermined pattern on the monitor screen as quickly as possible. For the answer, the person must press the desired key of each stimulus on the keyboard. Reaction time refers to the duration of the presentation of the stimulus until the response to it. Obviously, the faster a person responds, it shows the learning of the sequence and the better functioning of the central nervous and cognitive system of the person.

3

Description
Gait speed in Timed Up And Go Test.
Timepoint
In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session.
Method of measurement
Timed Up And Go test will be used to measure gait speed. In this test, the person has to get up from a chair with a handle with a height of approximately 46 cm and a handle height of 65 cm, walk 3 meters, go around an obstacle, turn around and sit down. The person performs this test in two conditions with and without the cognitive task at the same time.

4

Description
Measuring the psychological variable of fear of falling by Yardley et al.'s (2005) fear of falling scale.
Timepoint
In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session.
Method of measurement
This questionnaire contains 16 questions that people fill in two stages at the beginning and at the end of the training protocol. Higher scores in this test indicate greater fear of falling and lower self-efficacy.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1- Single task balance exercise 2- Dual task balance training group 3- Control group, In this research, the single task exercise group only practices balance exercises, while the dual task exercise group simultaneously performs cognitive activity at the same time as balance exercise. The control group in this research only participates in the pre-test and post-test.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Fateme Zahra Hospital
Full name of responsible person
Hossain Shirvani
Street address
Parvin Eetesami St,
City
Kerman
Province
Kerman
Postal code
76139 77895
Phone
+98 34 3246 6116
Email
Info@bmsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossain Shirvani
Street address
Vanak Square, Molla Sadra street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Info@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
hossain shirvani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
MollaSadra street,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
021880400600912
Email
shirvani.h2006@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hesam Iranmanesh
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Motor behaviour
Street address
No. 9 Rezvan alley, Rezvan blvd, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7618973741
Phone
+98 34 3281 4885
Email
hesam.iranmanesh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
hesam iranmanesh
Position
Phd
Latest degree
Master
Other areas of specialty/work
Motor behaviour
Street address
No. 9, Rezvan blvd, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7618973741
Phone
+98 34 3281 4885
Email
hesam.iranmanesh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
The data will be presented as results of the articles
When the data will become available and for how long
One year after publication
To whom data/document is available
The users of the data will be determined according to the opinion of the project officials and Baqiyatullah University of Medical Sciences
Under which criteria data/document could be used
Only under the supervision of Baqiyatullah University of Medical Sciences
From where data/document is obtainable
Baqiyatullah University of Medical Sciences
What processes are involved for a request to access data/document
After the completion of the testing process and a month has passed since its end, the applicant can receive the required information by sending an email to the address of Baqiyatullah University. It is obvious that the information will be provided to them at the discretion of Baqiyatullah University.
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