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CTRI Number  CTRI/2019/02/017869 [Registered on: 28/02/2019] Trial Registered Prospectively
Last Modified On: 23/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Scale to measure compliance to exercise 
Scientific Title of Study   Development and Validation of Adherence Rating Scale for healthy living 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Jairaj Suvarna 
Designation  Post Graduate Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  7259630130  
Fax    
Email  vaishnavisuvarna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishali K 
Designation  Professor, Head of Department 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9483929754  
Fax    
Email  vaishali.kh@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vaishali K 
Designation  Professor, Head of Department 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9483929754  
Fax    
Email  vaishali.kh@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, Karnataka. 576104 
 
Primary Sponsor  
Name  Ms Vaishnavi Jairaj Suvarna 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, Karnataka. 576104 
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 
Ms Vaishnavi Jairaj Suvarna  Cardiopulmonary Rehabilitation and Fitness Laboratory  Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 7259630130

vaishnavisuvarna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young healthy individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise intervention   Participants will be given an exercise protocol for three weeks.This protocol will be based on WHO recommendations 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Participants (male/female) between the ages of 18 – 40 with low risk to exercise as per AHA/ACSM pre participation screening 
 
ExclusionCriteria 
Details  Moderate - high risk to exercise as per AHA/ACSM pre participation screening. Participants who are not available to participate in the study. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Adherence rate will be assessed using exercise log. For tool development: Content validity will be established by the rating of 7-9 subject content experts Reliability will be established with Cronbach alpha score using item analysis  Time point for phases 1: Participants will be called once for focus group discussion.

Time point for phase 2: The developed scale will be given to 7-9 experts for validation. After the evaluation of the scale, the feedback collected back from the experts

Time point for phase 3: participants will be called twice with a gap of 21 days. First participants will be given intervention and an adherence dairy After 21 days, they will be called to return the dairy for evaluation.
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   15/03/2019 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This study is a mixed method research aimed to develop and validate a adherence rating scale for health living living. This study has three phases.
Phase 1: Gathering of data for item generation
An extensive literature review will be done to generate an interview set for the Focus group discussion. Three focus groups will be made with adherent to exercise and non-adherent participants individually. Therefore a total of six focus groups will be formed with 8 members in each. Total members for focus group discussion are 48. A focus group discussion will be conducted for each group. This discussion will be audio tape recorded and based on this recording a transcript will generated. This transcript will analyzed through inductive content analysis. 
Phase 2: Test Generation
The codes and themes identified from the inductive content analysis of the FGD will be used to generate items of the scale. Once the scale is developed it will be given to 7-9 expects for content validation.  The experts are individuals pursing PhD or have completed PhD in Physiotherapy or Psychology.  Based on the feedback from the experts, changes in the scale will be made. Translation and back translation of the final draft to Kannada and Hindi will be done.
Phase 3: Feasibility of the scale
The final scale will be given to 105 participants willing to participate in this study along with an exercise protocol to be followed for three weeks. This protocol will be based on WHO recommendations. An exercise log will be given to a close relative of the participant who will be blinded about the protocol. Information from the scale and the exercise log will be compared after three weeks.
 
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