Determining the effect of the Otago exercise program on the quality of life of stroke patients.
Design
A clinical trial with a control group, with parallel groups without blinding, randomized on 60 patients.
Settings and conduct
The research population is all the admitted stroke patients to Vali-Asr-Arak Hospital. The participating patients are placed in two control and test groups by random method. The demographic information questionnaire and the stroke impact scale (SIS)questionnaire are filled by the control and test group patients at the beginning of the research. Then, the patients from the intervention group will receive the Otago exercise program in addition to taking the usual care. Moreover, the patients of the control group will only take the usual care after the stroke. The (SIS) questionenaire will be filled by the patients of the test and control groups 1 and 3 months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion and exclusion criteria: Diagnosis of stroke by a neurologist, Passing less than 2 weeks after the patient’s stroke, Being older than 60 years old, Getting a score 7 and higher in Abbreviated Mental Test (AMT), Getting the score of 3 and less in Modified Rankin Scale in the stroke, Having the companion, Not having chronic renal failure, Not suffering from chronic diseases, Not Having musculoskeletal problems in the lower organs, Access to cell phone and EITAA application.
Intervention groups
The control group will take the usual care after the stroke. Moreover, the patients of the test group will take the Otago exercise program in addition to the usual care after the strokes, and will execute it for 8 weeks and 3 times a week.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221027056319N1
Registration date:2023-02-12, 1401/11/23
Registration timing:prospective
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Sajad Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3425 1158
Email address
sajadsalehi878@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-10, 1401/12/19
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of the Otago exercise program on quality of life of stroke patients.
Public title
Effect of Otago exercise program on stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of stroke by a neurologist
Passing less than 2 weeks after the patient’s stroke
Being older than 60 years
Getting a score 7 and higher in Abbreviated Mental Test (AMT)
Getting the score of 3 and less in Modified Rankin Scale (MRS) in the stroke
Having the companion
Access to cell phone and EITAA application (by the patient or the companion) to contact and remember the exercises.
Exclusion criteria:
Having an experience of stroke in the past
Having neurological disorders(dementia, Alzheimer's, Parkinson's, amyotrophic lateral sclerosis)
Having musculoskeletal problems in the lower organs such as significant muscular weakness as severe joint osteoarthritis and pelvic bone fracture complications
Having chronic renal failure
Heart complication (congestive heart failure) and lung disorder.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the block randomization method will be used. The randomization unit was personal in this research, and afflicted patients to stroke had inclusion criteria to the research based on the file number, and people's intention to participate in this research was convenience non-random. Then, they were attributed to groups A and B by the block randomization method (quadruple block). In this research, 6 various modes can be imagined based on having a quadruple volume of blocks which include AABB, ABAB, ABBA BBAA, BABA, and BAAB. The various modes of blocks will be written on cardboard cards of the same size and color. According to the sample volume (60 patients) and 6 modes for blocks, ten cards were selected randomly with the re-substitution and indicated the order of blocks and order of patients in group A (control) and group B (intervention).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Management of Research and Medical Information, Deputy of Research and Technology, University Complex of the Prophet (pbuh), Basij Square
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-12-10, 1401/09/19
Ethics committee reference number
IR.ARAKMU.REC.1401.275
Health conditions studied
1
Description of health condition studied
patients with stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Quality of life
Timepoint
Measuring the quality of life at the baseline (before the start of the intervention) and 1 and 3 months after the end of the intervention.
Method of measurement
Stroke Impact Scale Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Description of intervention: the test group will receive the educational intervention including the Otago exercise program in person and 5-member groups by gender separation with the companion’s participation in 3 sessions. The educational program will be executed for all groups by the researcher and based on the published booklet by Otago University with the supervision of a physiotherapist. In addition, an illustrated book containing transparent instructions and an educational video about how to perform the exercises are given to the patients to fix the presented information and to have more accurate performance. The exercise level is determined based on the patient’s condition by the physiotherapist. Then, an exercise schedule will be given to the patients, and they will be asked to do and record the rigid exercises three times a week for 30- 40 min at home under the supervision. Moreover, the 15-minute walking program is given to the patient 2 times a week. The researcher will contact the patients at the end of each week to follow up on these exercises. Furthermore, the phone number of the researcher is given to the patients to call whenever they have a problem with their exercises, how to do them, or the level of exercises. Generally, this exercise program includes walking, turning the head to the sides, bending the body back, turning the body to the sides, moving the ankle up and down, straightening the knee (with weights), bending the knee, opening legs from the sides, standing on the toes, standing on the heels, bending the knees, walking on the toes, walking on the heels, putting the feet together, walking backward, standing on one leg, walking sideways, walking backward, getting up and sitting down from a chair, walking and turning, going up and down stairs, and stretching the muscles of the back of the leg and thigh. In addition to strength exercises, weights of 0.5-2 kg will be given to the patients based on their ability and the diagnosis of the physiotherapist. The patients were asked to make a video of their performed exercises each week to increase the assurance of doing the exercises accurately and sending it by EITA software. The exercise duration will be 8 weeks. The test groups will receive the usual care after the stroke in addition to the Otago exercise program.
Category
Rehabilitation
2
Description
Control group :The control group will receive the usual care after the stroke in all research period. In addition, the Otago exercise program will be given to the control group at the end of research for the ethical considerations.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Vali-asr
Full name of responsible person
Sajad Salehi
Street address
Vali-asr St, Vali-asr Hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3383 8242
Email
sajadsalehi878@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
Deputy of Research and Technology, University complex of the great prophet (pbuh), Basij Squere, Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.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 of Medical Sciences
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 of Medical Sciences
Full name of responsible person
Sajad Salehi
Position
Nursing master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Corner of Hamidi nasab Alley., Tafresh st., Shohada Ave
City
Arak
Province
Markazi
Postal code
3814713497
Phone
+98 86 3425 1158
Email
sajadsalehi878@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Saiedeh Bahrampouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3425 1158
Email
s.bahrampouri@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sajad Salehi
Position
Nursing master student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Corner of Hamidi nasab Alley., Tafresh st., Shohada Ave
City
Arak
Province
Markazi
Postal code
3814713497
Phone
+98 86 3425 1158
Email
sajadsalehi878@gmail.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