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CTRI Number  CTRI/2024/07/070221 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on knowledge, attitude, and preparedness for exercise among people at risk of stroke 
Scientific Title of Study   Cross-sectional study on knowledge, attitude, and preparedness for physical activity among individuals at risk of stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheik Asifa Parveen 
Designation  Post graduate student 
Affiliation  Father Muller Medical College & Hospital 
Address  Department of Neurophysiotherapy, Father Muller Medical College & Hospital Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7337785580  
Fax    
Email  asifasheik252@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Garima Gupta 
Designation  Associate professor  
Affiliation  Father Muller Medical College & Hospital 
Address  Department of Neurophysicotherapy, Father Muller Medical College & Hospital Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7897044180  
Fax    
Email  garima.gupta@fathermuller.in  
 
Details of Contact Person
Public Query
 
Name  SHEIK ASIFA PARVEEN 
Designation  Post graduate student 
Affiliation  Father Muller Medical College & Hospital 
Address  Department of Neurophysiotherapy, Father Muller Medical College & Hospital Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7337785580  
Fax    
Email  asifasheik252@gmail.com  
 
Source of Monetary or Material Support  
Father Muller College of Physiotherapy, Kankanady, Mangalore, Dakshina Kannada, Karnataka, India. Pin code: 575002 
 
Primary Sponsor  
Name  SHEIK ASIFA PARVEEN 
Address  Department of Neurophysiotherapy, Father Muller Medical College & Hospital Kankanady, Mangalore, Karnataka, India 575002  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheik Asifa Parveen  Father Muller Medical College & Hospital  Medicine OutPatient department, Kankanady, Mangalore, 575002
Dakshina Kannada
KARNATAKA 
7337785580

asifasheik252@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z000||Encounter for general adult medical examination,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  At high risk or caution risk of stroke according to criteria of the National Stroke Association for Stroke Risk Scorecard.
Willing to voluntarily participate.
Able to read or understand English or Kannada. 
 
ExclusionCriteria 
Details  Any known cognitive, neurological, musculoskeletal, psychiatric, terminal illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A customised and content-validated research questionnaire on knowledge, attitude, and preparedness for physical activity among individuals at risk of stroke  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Global Physical Activity Questionnaire (GPAQ) will be used to assess the current level of physical activity among individuals at risk of stroke.   at baseline 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

NEED FOR THE STUDY:

Stroke is a leading cause of morbidity and mortality which places physical, cognitive, emotional, behavioral, and financial burdens. (1),(2) However, it’s preventable by early identification and modification of risk factors. (3) Physical inactivity is emphasized as a key, modifiable risk factor and has a crucial role in decreasing stroke incidence. (4)

As per World Health Organisation (WHO) recommendations, all adults as well as the aged must perform at least 150–300 minutes of moderate-intensity or 75-150 minutes of vigorous-intensity aerobic Physical Activity (PA), or an equivalent combination of both in a week along with moderate or higher intensity muscle-strengthening on at least 2 days a week to achieve significant health benefits. Aged individuals must include functional balance training on 3 or more days a week. (5)

Individuals who overestimate their PA levels probably believe PA is less advantageous and thereby show lack of desire to increase PA when compared to those who are practical about it. Personalized feedback about PA can play a crucial role in attitude and behavior change. (6)

The Transtheoretical Model of Change explains behavior change by expressing it as a sequence of stages and processes. Stages of Change describe where individuals are in their preparedness for change in five stages: pre-contemplation, contemplation, preparation, action, and maintenance whereas the processes of change explain how individuals modify their behavior using strategies and techniques and can be categorized as cognitive and behavioral processes. (7)

Those individuals who are at risk of stroke need to know the guidelines for PA and follow them for stroke prevention, thereby reducing its burden. However, in the Indian context, the demographic data is missing about the knowledge, attitude, and preparedness for PA among individuals at risk of stroke. Hence there is a need for a study that assesses the knowledge, attitude, and preparedness for PA among individuals at risk of stroke.

REVIEW OF LITERATURE:

Veluswamy et al., in the year 2014 conducted a cross-sectional study to understand the perceptions and awareness of health benefits of PA on chronic diseases among rural coastal South India residents.  The study sample included 409 adults living in the selected household for not less than six months and were administered a content-validated questionnaire. Out of which 86.1 % were physically active; 10.5% perceived the need to increase their PA; 89% perceived an active lifestyle; and 75.1 % felt the health benefits of PA but did not report the health benefits of PA on chronic diseases. (1)

Mwimo JL, et al., conducted a cross-sectional study in the year 2021 to evaluate the knowledge, attitude, and practice of PA among diabetic patients in the Kilimanjaro region, including 315 diabetic patients attending the diabetic clinic. Out of which, 98.4% of patients had good knowledge of PA, 95.6% of them had a suitable attitude toward PA, and 94.3% of them had adequate levels of PA.(8)

F. Islam et al., in the year 2021 conducted a study to evaluate the knowledge of the health benefits of PA and attitudes among hypertensive individuals residing in a rural area in Bangladesh. The study included 307 participants with hypertension in the age group of 30-75 years. Global Physical Activity Questionnaire version 2 (GPAQ-2) was administered to the participants to assess PA levels and they were interviewed to assess their attitude towards PA. 44% of the participants had low PA levels, 95% had awareness about the benefits of PA on health but only 10% were interested in organizing PA programs. (6)

OBJECTIVES OF THE STUDY:

To evaluate the knowledge of WHO-recommended PA guidelines, attitude towards their involvement in PA, and their preparedness for engaging in PA using a content-validated questionnaire among individuals at risk of stroke.

To assess the current level of PA among individuals at risk of stroke using GPAQ.


MATERIAL AND METHODS:

SOURCE OF DATA

STUDY SETTING: Medicine OutPatient Department of Father Muller Medical College Hospital.

STUDY SUBJECTS/PARTICIPANTS: Individuals at high risk and caution risk of stroke according to the Stroke Risk Scorecard. (9)


METHOD OF COLLECTION OF DATA

STUDY DESIGN:  Cross-sectional study

STUDY DURATION: 1 year

SAMPLE SIZE CALCULATION:  Based on the sample size guideline for survey research, the minimum sample size required is (15 X 12)=180.(10) But to allow for a possible 20% non-valid questionnaire rate in the survey responses, at least 216 participants will be required.

INCLUSION CRITERIA:

Aged 18 years and above

All gender

At high risk or caution risk of stroke according to criteria of the National Stroke Association for Stroke Risk Scorecard. (9)

Willing to voluntarily participate

EXCLUSION CRITERIA:

Able to read or understand English or Kannada Any known, cognitive, neurological, musculoskeletal, psychiatric, or terminal illness.

OUTCOME MEASURES:

A customized and content-validated research questionnaire will be used to evaluate the knowledge of WHO-recommended PA guidelines, their attitude toward their involvement in PA, and their preparedness for engaging in PA.

GPAQ will be used to assess the current level of PA among individuals at risk of stroke. (11)

PROCEDURE FOR QUESTIONNAIRE PREPARATION & IT’S CONTENT-VALIDATION:

The initial pool of 15 questions regarding the knowledge, attitude, and preparedness for PA according to WHO guidelines and the Transtheoretical Model of Change was developed by the primary investigator.  This initial draft was then sent to five experts in the field of Research in knowledge, attitude, and practice for establishing its face and content validity. Based on experts’ comments, 3 questions were discarded. The final questionnaire has 12 questions. For testing the understanding and ease of readability, feedback was taken from six individuals.

MATERIALS REQUIRED:

Copy of Outcome Measures: Customised research questionnaire, GPAQ

Paper/pen

Screening form

Participant Information sheet

Informed Consent form

Data Collection sheet

PROCEDURE:

Approval has been obtained from Institutional Review Committee and Institutional Ethics Committee. Screening of patients will be done according to the inclusion and exclusion criteria. Informed consent will be obtained from the patients. Demographic details will be recorded. Study participants will be interviewed about their knowledge, attitude, and preparedness for PA using a content-validated questionnaire and about the current level of PA using GPAQ. Data will be collected and analyzed.

STATISTICAL ANALYSIS:

Descriptive statistics will be used to analyze the demographic data and the data will be reported as mean and standard deviation.

Frequency and Percentages will be used to report the knowledge, attitude, and preparedness for PA among individuals at risk of stroke.

IMPLICATION OF THE STUDY:

It will help develop scientific literature about knowledge, attitude, and preparedness for PA among individuals at risk of stroke which may help Physiotherapists lay down better prevention models for stroke prevention.

LIST OF REFERENCES:

1.        Veluswamy SK, Maiya AG, Nair S, Guddattu V, Nair NS, Vidyasagar S. Awareness of chronic disease related health benefits of physical activity among residents of a rural South Indian region: A cross-sectional study. Int J Behav Nutr Phys Act [Internet]. 2014;11(1):1–8. Available from: International Journal of Behavioral Nutrition and Physical Activity

2.        Effects of Stroke | American Stroke Association [Internet].

3.        Boehme AK, Esenwa C, Elkind MSV. Stroke Risk Factors, Genetics, and Prevention. Circ Res. 2017;120(3):472–95.

4.        Tran P, Tran L, Tran L. ARTICLE IN PRESS A Cross-Sectional Analysis of Differences in Physical Activity Levels between Stroke Belt and Non-Stroke Belt US Adults. 2019;1–9.

5.        Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, et al. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020;54(24):1451–62.

6.        Islam FMA, Hosen MA, Islam MA, Lambert EA, Thompson BR, Lambert GW, et al. Knowledge of and intention to participate in physical activity programs and their associated sociodemographic factors in people with high blood pressure in a rural area of bangladesh: Initial investigation from a cluster randomized controlled trial. Int J Environ Res Public Health. 2021;18(18).

7.        Jiménez-Zazo F, Romero-Blanco C, Castro-Lemus N, Dorado-Suárez A, Aznar S. Transtheoretical model for physical activity in older adults: Systematic review. Int J Environ Res Public Health. 2020;17(24):1–14.

8.        Mwimo JL, Somoka S, Leyaro BJ, Amour C, Mao E, Mboya IB. Knowledge, attitude and practice of physical activity among patients with diabetes in Kilimanjaro region, Northern Tanzania: A descriptive cross-sectional study. BMJ Open. 2021;11(9):1–7.

9.        Tarwoto, Elsye Rahmawaty, Argianto, Muhammad Yusro. Effectiveness Test Of Stroke Risk Detection Application Model, Stroke Risk Scorecard (STRIC). J World Sci [Internet]. 2023;2(2):292–9.

10.      Rahman MM. Sample size determination for survey research and non-probability sampling techniques: A review and set of recommendations. J Entrep Bus Econ [Internet]. 2023;11(1):42–62.

11.      Keating XD, Zhou K, Liu X, Hodges M, Liu J, Guan J, et al. Reliability and concurrent validity of global physical activity questionnaire (GPAQ): A systematic review. Int J Environ Res Public Health. 2019;16(21). 

 
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