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The effect of home-based exercise in older adults

Protocol summary

Study aim
The aim of the present study is to help the elderly adult during the corona pandemic to perform home-based exercise to improve postural control, physical self-efficacy and improve their quality of life.
Design
Double-blind randomized clinical trial with control group (n=36).
Settings and conduct
The present quasi-experimental study is performed in the rehabilitation laboratory of Arak University. The experimental groups performs Otago and Fit and fall proof home-based exercise for 8 weeks, 3 sessions per week. Static and dynamic balance, quality of life, fear of falling, physical and cognitive self-efficacy measure with 4 stage static balance test, timed up and go test, OPQOL-35, FES-I questionnaire, SSEA and MMSE quesionnaire respectively. Data analyzer and evaluators do not know how to allocate and group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 60-80 years, no history of spine surgery and hip replacement. Exclusion criteria: history of cardio-respiratory disorders in the last two years, visual impairment, severe musculoskeletal disorders such as severe osteoarthritis.
Intervention groups
Intervention groups: The participants in the intervention group 1,2 perform Otago and fit and fall proof exercises respectively for eight weeks, three sessions per week. Control group: They will have the usual routine of their lives.
Main outcome variables
Static and dynamic balance, quality of life, fear of falling, physical and cognitive self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200204046368N6
Registration date: 2021-08-14, 1400/05/23
Registration timing: registered_while_recruiting

Last update: 2021-08-14, 1400/05/23
Update count: 0
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-12, 1400/05/21
Expected recruitment end date
2021-08-20, 1400/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of home-based exercise in older adults
Public title
Home based exercise and older adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 to 80 years No neurological disorders such as Alzheimer's, MS, Parkinson's No musculoskeletal disorders such as rheumatoid arthritis and muscular dystrophy
Exclusion criteria:
History of spine or hip surgery Visual impairment Any illness that can affect the research variables
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is parallel. The randomization unit is individual. The Randlist software is used to randomly assign subjects to study groups. At , the number of subjects and groups is given to the software. Then, with this software, each subject is assigned a code. A group is then randomly assigned to each code by the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher that do laboratory tests were not aware of the allocation of study groups. The data analyzer will not be aware of the groups classification. The information of the groups will be provided to the data analyzer in the form of numbers 1, 2, 3 and for each participant with a code.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bu Ali Sina university ethics committee in research
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2021-07-10, 1400/04/19
Ethics committee reference number
IR.BASU.REC.1400.022

Health conditions studied

1

Description of health condition studied
---
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Static and dynamic balance
Timepoint
Before and after 8 week intervention
Method of measurement
4 stage static balance test and timed up and go test

2

Description
Quality of life
Timepoint
Before and after 8 week intervention
Method of measurement
Older People’s Quality of Life Questionnaire (OPQOL-35)

3

Description
Fear of falling
Timepoint
Before and after 8 week intervention
Method of measurement
Falls Efficacy Scale - International Questionnaire (FES-I)

4

Description
physical and cognitive self-efficiency
Timepoint
Before and after 8 week intervention
Method of measurement
self-efficacy scale (SSES) questionnaire and Mini-Mental State Exam (MMSE) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: The intervention group 1 performs Otago exercises for 8 weeks, 3 sessions per week. Subjects are monitored by researchers every week. They write down their activity level in a notebook.Exercise booklet including complete guide and video including explanations and how to perform the exercises correctly will be provided to the participants.
Category
Rehabilitation

2

Description
Intervention group 2: The intervention group 2 performs Fit and fall proof exercises for 8 weeks, 3 sessions per week. Subjects are monitored by researchers every week. They write down their activity level in a notebook.Exercise booklet including complete guide and video including explanations and how to perform the exercises correctly will be provided to the participants.
Category
Rehabilitation

3

Description
Control group: The control group performs their normal activities for 8 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak university
Full name of responsible person
Zahra Raeisi
Street address
Shariati street
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3277 4031
Email
Z_raisi13@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak university
Full name of responsible person
Alireza Fazlali
Street address
Shariati street
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 2000
Email
d-research@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Basij Square, Arak University
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@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
Not applicable
Data Dictionary
Not applicable
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