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CTRI Number  CTRI/2024/06/069555 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Challenges faced by stroke survivors for performing physical activity in coastal Karnataka, India  
Scientific Title of Study   Barriers to physical activity among stroke survivors in coastal Karnataka, India. A cross sectional study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Menezes Dalton Dolphy 
Designation  Post Graduate Student 
Affiliation  Father Muller College of Physiotherapy 
Address  Father Muller College of Physiotherapy, Father Muller Medical college Hospital Kankanady Manguluru
Department of Physiotherapy 3rd floor R ward Asha Kiran Building Father Muller Medical college Hospital Kankanady Manguluru
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9167636362  
Fax    
Email  menezesdalton7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Garima Gupta 
Designation  Associate Professor 
Affiliation  Father Muller College of Physiotherapy 
Address  Father Muller College of Physiotherapy FMCI Kankanady Manguluru
Department of Physiotherapy 3rd floor R ward Asha Kiran Building Father Muller Medical college Hospital Kankanady Manguluru
Dakshina Kannada
KARNATAKA
575002
India 
Phone  7897044180  
Fax    
Email  garima.gupta@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Menezes Dalton Dolphy 
Designation  Post Graduate Student 
Affiliation  Father Muller College of Physiotherapy 
Address  Department of Physiotherapy 3rd floor R ward Asha Kiran Building Father Muller Medical college Hospital Kankanady Manguluru
Father Muller College of Physiotherapy FMCI Kankanady Manguluru
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9167636362  
Fax    
Email  menezesdalton7@gmail.com  
 
Source of Monetary or Material Support  
Father Muller College of Physiotherapy Department of Physiotherapy 3rd floor R ward Asha Kiran Building Father Muller Medical college Hospital Kankanady Manguluru 575002 Karnataka, India 
 
Primary Sponsor  
Name  Father Muller Medical College and Hospitals 
Address  Kankannady, Mangalore-575002, Karnataka, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Dalton Menezes  Father Muller Medical College Hospital   OPD and IPD Neurology, First Floor Room 16, OPD and IPD Physiotherapy, R-ward, Father Muller Medical College Hospitals and Charitable Institutions Kankanady Manguluru
Dakshina Kannada
KARNATAKA 		 9167636362

menezesdalton7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee (FMIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I60-I69||Cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Type of Stroke Ischemic Stroke and Hemorrhagic Stroke

2. Modified Rankin Score ≤3

3. Ability to understand and follow simple commands

4. The patient should be able to walk at a speed ≥ 40m/s in the 10-metre walk test  
 
ExclusionCriteria 
Details  1. Unwilling to participate

2. Neurological symptoms due to any other medical condition apart from stroke

3. Acute or Chronic Pain due to any Illness / Injury that may affect ambulation

4. Any musculoskeletal, orthopedic, or cardiovascular disorder that may affect ambulation

5. Congenital deformities that may affect ambulation

6. Medically diagnosed cases of psychiatric illnesses

7. Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify barriers to physical activity among stroke survivors in Coastal Karnataka, India using the
Barriers to Physical Activity after Stroke
Barriers to Being Active Quiz
 		 Once during the study at baseline during recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the current level of physical activity among stroke survivors in Coastal Karnataka, India using global physical activity questionnaire  Once during the study at baseline during recruitment 
 
Target Sample Size   Total Sample Size="367"
Sample Size from India="367" 
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)   05/07/2025 
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 the third-leading cause of disability globally. The burden of disability due to stroke was high with 89% of Disability Affected Life Years (DALYs) being in developing countries. [1]

Regular physical activity (PA) is advised to lower the chances of experiencing additional strokes and enhance the mental, physical, and psychosocial well-being of individuals who have had a stroke. [2] As per the ACSM guidelines, adults should engage in at least 30 minutes of moderate-intensity exercise on five days per week, totalling a minimum of 150 minutes per week. [3] Exercise is paramount for recovery from physical disability due to stroke hence we must focus on initiating exercise as early as possible. [4]

Despite these benefits, PA levels among stroke survivors still fall short of the recommended thresholds. Approximately 77% of individuals who have had a stroke lead sedentary lifestyles or engage in minimal physical activity, accompanied by decreased frequency of exercise. [5]

Identification of the barriers to exercise after stroke will provide us with a deeper understanding of sedentary behaviour in these patients. The studies done on barriers to physical activity are mostly done in developed countries. Hence this study aims to identify and quantify barriers in the Indian context.

REVIEW OF LITERATURE 

 A cross-sectional study was conducted on patients with stroke. To investigate the perceived barriers to exercise in stroke survivors who can walk in the community. This study included 95 individuals who were diagnosed with stroke, and ≥ 20 years of age. The main outcome measure used was the Exercise Benefits and Barriers Scale (EBBS). The three commonly reported barriers were, fatigue after exercising was the main barrier to exercise, reduced number of places to practice, and long distances to exercise places. [6] 

A systematic review of qualitative studies was conducted in post-stroke patients. To understand the adherence of these patients to recovery-oriented self-practice outside of clinical settings. This study included 12 papers. The articles were based on 108 individuals who were diagnosed with stroke, and ≥ 18 years of age. Four analytical themes were drawn out from these studies. The review emphasizes the importance of tailoring self-practice programs to patients’ situations and preferences, and highlights how adherence can be shaped by self, others (the team of prescribing therapists and caregivers), and an individual’s everyday reality. [7] 

A cross–sectional study was conducted on patients with stroke. To identify barriers to physical activity faced by stroke survivors in Singapore. This study included 38 individuals who were diagnosed with stroke, and ≥ 21 years of age. The main outcome measure used was the Barriers to Physical Activity Questionnaire- Mobility Impairments (BPAQ-MI). The three commonly reported barriers were, the three most commonly reported barriers included lack of accessible classes for exercise, lack of assistance for exercise and fatigue from exercise. [8] 

A cross–sectional study was conducted on patients with stroke. To identify barriers to physical activity faced by stroke survivors in Nigeria. This study included 121 individuals who were diagnosed with stroke, and ≥ 30 years of age. The main outcome measure used was the Exercise Benefits and Barriers Scale (EBBS). The three commonly reported barriers were, The four most commonly reported barriers were limited access to exercise facilities, exercise facilities not having convenient schedules exercise taking too much time and lack of encouragement from spouse. [9]

Aim of The Study: 

This study aims to identify barriers to physical activity among stroke survivors in Coastal Karnataka, India. 

OBJECTIVE OF THE STUDY: 

To identify barriers to physical activity among stroke survivors in Coastal Karnataka, India using the 

➢ Barriers to Physical Activity after Stroke (BAPAS) 

➢ Barriers to Being Active Quiz (BBAQ) 

To identify the current level of physical activity among stroke survivors in Coastal Karnataka, India using global physical activity questionnaire (GPAQ). 


MATERIALS AND METHODS:

SOURCE OF DATA 

Study Setting: OPD Neurology and IPD of Father Muller Medical College Hospital, Mangaluru. 

Study Subjects/Participants: Stroke Survivors 

METHODS OF DATA COLLECTION 

Study Design: Cross-sectional study Study Duration: One year 

Sample Size Calculation: Taking the prevalence rate to be 39.2%, d (margin of error) = 5%, Z α (confidence interval) = 1.96, n = 367 [10] 

Inclusion Criteria: 

•        Age ≥ 21 years

•        Type of Stroke- Ischemic Stroke and Hemorrhagic Stroke

•        Modified Rankin Score (mRS) ≤3 (Validity = 0.89) [11]

•        Ability to understand and follow simple commands

•        The patient should be able to walk at a speed ≥ 40m/s in the 10-metre walk test [12]

Exclusion Criteria:

•        Unwilling to participate

•        Neurological symptoms due to any other medical condition apart from stroke

•        Acute or Chronic Pain due to any Illness / Injury that may affect ambulation

•        Any musculoskeletal, orthopedic, or cardiovascular disorder that may affect ambulation

•        Congenital deformities that may affect ambulation

•        Medically diagnosed cases of psychiatric illnesses

•        Pregnant and lactating women

Outcome Measures: 

GPAQ: Global Physical Activity Questionnaire [13]

BAPAS: Barriers to Physical Activity after Stroke scale [14]

BBAQ: Barriers to Being Active Quiz [15]

Materials Required:

-        Copy of outcome measures: BAPAS, BBAQ, GPAQ

-        Standard chair

-        Paper/pencil 

-        Data collection sheet

-        Participant Information Sheet

-        Informed consent form

Procedure: 

Written informed consent will be obtained from the patients/caregivers/family members. Stroke survivors will be screened according to the inclusion and exclusion criteria. The demographic data will be noted. The participants will be informed that their current physical activity levels will be noted using the Global Physical Activity Questionnaire (GPAQ) scale. The participants will be informed that their barriers to physical activity will be assessed using two outcome measures namely the Barriers to Physical Activity after Stroke (BAPAS) and the Barriers to Being Active Quiz (BBAQ) scale. The BAPAS and BBAQ instruments will be administered to the participants, and data will be collected using the respective data collection forms. Both the instruments will be administered on the same day.

Statistical Analysis:

•        Demographic data will be analyzed using descriptive statistics and reported as mean as the current level and standard deviation (SD)

•        Frequency and Percentages will be used to report the knowledge of WHO recommended PA guidelines, the attitude, and the preparedness of individuals at risk of stroke towards their involvement in PA

Implication Of The Study:

This study will help therapists understand the barriers to physical activity among stroke survivors in coastal Karnataka, India. 

LIST OF REFERENCES:

1.     Feigin VL, Stark BA, Johnson CO, Roth GA, Bisignano C, Abady GG, Abbasifard M, Abbasi-Kangevari M, Abd-Allah F, Abedi V, Abualhasan A. Global, regional, and national burden of stroke and its risk factors, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet Neurology. 2021 Oct 1;20(10):795-820.

2.     van Wijck F, Bernhardt J, Billinger SA, Bird ML, Eng J, English C, Teixeira-Salmela LF, MacKay-Lyons M, Melifonwu R, Sunnerhagen KS, Solomon JM. Improving life after stroke needs global efforts to implement evidence-based physical activity pathways. International Journal of Stroke. 2019 Jul;14(5):457-9.

3.     Pescatello LS, editor. ACSM’s guidelines for exercise testing and prescription. Lippincott Williams & Wilkins; 2014.

4.     Askim T, Bernhardt J, Salvesen Ø, Indredavik B. Physical activity early after stroke and its association to functional outcome 3 months later. Journal of Stroke and Cerebrovascular Diseases. 2014 May 1;23(5):e305-12.

5.     Senes S. How we manage stroke in Australia. Australian Institute of Health and Welfare and University of Sydney; 2006.

6.     Débora Pacheco B, Guimaraes Caetano LC, Amorim Samora G, Sant’Ana R, Fuscaldi Teixeira-Salmela L, Scianni AA. Perceived barriers to exercise reported by individuals with stroke, who are able to walk in the community. Disability and rehabilitation. 2021 Jan 30;43(3):331-7.

7.     Vadas D, Prest K, Turk A, Tierney S. Understanding the facilitators and barriers of stroke survivors’ adherence to recovery-oriented self-practice: a thematic synthesis. Disability and Rehabilitation. 2022 Oct 23;44(22):6608-19.

8.     Teo R, Thilarajah S, Jiale L, Yu FL, Khim KL. Barriers to physical activity of stroke survivors in Singapore: A face-to-face cross-sectional survey. Proceedings of Singapore Healthcare. 2023 Jun 14; 32:20101058231184953

9.     Idowu OA, Adeniyi AF, Ogwumike OO, Fawole HO, Akinrolie O. Perceived barriers to physical activity among Nigerian stroke survivors. Pan African Medical Journal. 2015;21(1).

10.  Nicholson SL, Greig CA, Sniehotta F, Johnston M, Lewis SJ, McMurdo ME, Johnston D, Scopes J, Mead GE. Quantitative data analysis of perceived barriers and motivators to physical activity in stroke survivors. Journal of the Royal College of Physicians of Edinburgh. 2017 Sep;47(3):231-6.

11.  Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar 1;38(3):1091-6.

12.  Watson MJ. Refining the ten-metre walking test for use with neurologically impaired people. Physiotherapy. 2002 Jul 1;88(7):386-97.

13.  Cleland CL, Hunter RF, Kee F, Cupples ME, Sallis JF, Tully MA. Validity of the global physical activity questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour. BMC public health. 2014 Dec; 14:1-1

14.  Drigny J, Joussain C, Gremeaux V, Morello R, Van Truc PH, Stapley P, Touzé E, Ruet A. Development and validation of a questionnaire to assess barriers to physical activity after stroke: the barriers to physical activity after stroke scale. Archives of physical medicine and rehabilitation. 2019 Sep 1;100(9):1672-9. 

15. Zalewski K, Alt C, Arvinen-Barrow M. Identifying barriers to remaining physically active after rehabilitation: differences in perception between physical therapists and older adult patients. journal of orthopaedic & sports physical therapy. 2014 Jun;44(6):415-24. 


 
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