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CTRI Number  CTRI/2025/05/087753 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Qualitative Study 
Study Design  Other 
Public Title of Study   Exploring Factors Influencing Patients Participation in Cardiac Rehabilitation  
Scientific Title of Study   Exploring Barriers and Facilitators to Cardiac Rehabilitation among Cardiovascular Disease Patients: A Qualitative 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  Aarzoo Minnat Ansari 
Designation  PhD Scholar 
Affiliation  Veer Narmad South Gujarat University 
Address  PG SECTION
SPB Physiotherapy College Ugat Bhesan Road
Surat
GUJARAT
395007
India 
Phone  9974899245  
Fax    
Email  aarzoo.minnat28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prakash Patel 
Designation  Associate Pofessor 
Affiliation  SPB PHYSIOTHERAPY COLLEGE 
Address  DEPARTMENT OF CARDIOPULMONARY SCIENCES Udhna Magdalla Road
VEER NARMAD SOUTH GUJARAT UNIVERSITY PG SECTION
Surat
GUJARAT
395004
India 
Phone  7874512423  
Fax    
Email  dr.prakash84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aarzoo Minnat Ansari 
Designation  PhD Scholar 
Affiliation  Veer Narmad South Gujarat University 
Address  PG Section Udhna Magdalla Road Surat
SPB Physiotherapy College Bhesan Rd Ugat Bhesan Road
Surat
GUJARAT
395007
India 
Phone  9974899245  
Fax    
Email  aarzoo.minnat28@gmail.com  
 
Source of Monetary or Material Support  
SPB PHYSIOTHERAPY COLLEGE SURAT 
 
Primary Sponsor  
Name  Dr Prakash Patel 
Address  Bhesan Rd Ugat Bhesan Road Rander Road Mora Bhagal Surat Gujarat 395004 
Type of Sponsor  Other [Self] 
 
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 Prakash Patel  SPB Physiotherapy College  Department of Cardiopulmonary Sciences, 1st Floor
Surat
GUJARAT 
7874512423

dr.prakash84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee South Gujarat Medical Education and Research Center SPB Physiotherapy College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I20-I25||Ischemic heart diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients between 30-60 years with a confirmed diagnosis of cardiovascular disease.
Patients those who have been referred to a rehabilitation program.
Patients who voluntarily agree to participate in the study and share their experiences or perspectives.
Patients who can communicate fluently in the language(s) used for data collection (e.g., Gujarati or English). 
 
ExclusionCriteria 
Details  Patients with severe cognitive impairment or mental health conditions.
Patients with terminal illness or end-stage conditions.
Patients with non-cardiovascular disabilities that significantly impede participation in rehabilitation.
Individuals unwilling or unable to engage in the study voluntarily.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Semi-structured interview guide translated in English and Gujarati   AT BASELINE ONLY 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/07/2025 
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="2"
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   Approval from the Institutional Ethical Committee will be obtained. The study will be done in two phases. The first phase includes the development of the Interview Guide and in the second phase, interviews of the CVD patients will be conducted.
Development of the Interview Guide: The first phase involves developing a semi-structured interview guide, ensuring that it comprehensively captures the factors influencing outpatient CR participation among CVD patients. The development of the interview guide will involve four steps:
Step 1: Literature Review and Item Generation: A comprehensive literature search is conducted using PubMed, CINAHL, and GOOGLE Scholar to identify previous studies that discuss the factors associated with the utilization of CR. Search terms included: "cardiovascular diseases," "cardiac rehabilitation in India," and "barriers and facilitators of cardiac rehabilitation." Findings from four prior studies were reviewed to generate relevant interview items. These items were categorized into key themes such as awareness, accessibility, psychological barriers, economic constraints, and support systems. 
Step 2: Translation and Validation: The interview guide will be developed in English and Gujarati by professional linguistic experts, with expertise in both the language. A back-translation process will be conducted to ensure linguistic and conceptual equivalence. Additionally, a panel of subject matter experts in cardiology, rehabilitation, and qualitative research will validate the guide for accuracy and comprehensiveness.
Step 3: Cognitive Interviews (Think-Aloud Method): To assess the clarity and relevance of the interview guide, cognitive interviews will be conducted with representatives involved in CR, including healthcare professionals and CVD patients. The think-aloud method will be used, where participants will read questions aloud and verbalize their thoughts, helping researchers evaluate how questions are interpreted. These interviews will be audio-recorded, transcribed, and analyzed for potential refinements. 
Step 4: Pilot Study: A pilot study will be conducted with 5-7 participants who share similar characteristics with the study population. This process helps the researcher identify any flaws, limitations, or weaknesses in the interview design, allowing for necessary revisions before the actual study is conducted. Additionally, the pilot test aids researchers in refining their research questions, a topic that will be explored in the following section. Following the pilot study, necessary modifications will be made, and the final version of the interview guide will be prepared for implementation. 
Interview of CVD Patients: This study adopts a phenomenological approach to explore the lived experiences of CVD patients in participating in CR. Phenomenology is ideal for uncovering deep, personal insights into the subjective experiences, beliefs, and attitudes that influence CR participation, enabling a holistic understanding of barriers and facilitators. The steps are detailed below:
Recruitment of Participants: With the necessary approvals from the hospital, participants for the study will be selected through purposive sampling to ensure a diverse representation across various factors, including age, gender, socioeconomic status, cultural background, and the extent of their participation in CR programs. To facilitate recruitment, potential participants will be identified and approached only after prior consultation with their treating physicians. The study population will consist of adult patients diagnosed with CVD, specifically those aged between 30 and 60 years, who have been referred to outpatient CR programs in hospitals and rehabilitation centers across the Surat region. Recruitment efforts will take place within both inpatient and outpatient cardiac care departments. Eligible participants will be identified with the active involvement of cardiologists, physiotherapists, and rehabilitation staff, who will assist in screening and selecting individuals who meet the study’s inclusion criteria.
Obtaining Informed Consent: Each potential participant will be provided with a Participant Information Sheet in English and Gujarati, detailing the study’s objectives, procedures, risks, and benefits. Written informed consent will be obtained before participation, ensuring patients understand their rights, including the option to withdraw at any time without consequences. Anonymity and confidentiality will be maintained, with each participant assigned a unique identification number to protect their identity. 
Conducting Semi-Structured Interviews: Face-to-face, in-depth interviews will be conducted in a quiet and comfortable setting (e.g., hospital consultation rooms or rehabilitation centers). The interviews will be conducted in Gujarati or English, depending on the participant’s preference, and audio-recorded with consent. A semi-structured interview guide, developed in Phase 1, will be used to collect the data. 
Ensuring Thematic Saturation: Data collection will continue until thematic saturation is achieved, meaning no new themes or insights emerge. Based on existing qualitative research, saturation typically occurs between 20-30 interviews, though this will be assessed continuously. 
 
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