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CTRI Number  CTRI/2018/07/015051 [Registered on: 26/07/2018] Trial Registered Prospectively
Last Modified On: 23/07/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Physical activity for health ageing and well being  
Scientific Title of Study   Physical activity to improve wellbeing and promote healthy ageing among older adults: Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anita Choudhary 
Designation  Professor and HOD 
Affiliation  Department of Physiology, R D Gardi Medical College 
Address  R D Gardi Medical College Department of Physiology, 2nd floor Agar Road Village Surasa Ujjain

Ujjain
MADHYA PRADESH
4560006
India 
Phone  00917368261235  
Fax  00917368261235  
Email  uctharc@sancharnet.in  
 
Details of Contact Person
Scientific Query
 
Name  Vishal Diwan 
Designation  Associate Professor  
Affiliation  Public Health and Environment  
Address  Public Health and Environment Ground Floor R D Gardi Medical College Agar Road Village Surasa Ujjain

Ujjain
MADHYA PRADESH
4560006
India 
Phone  00917368261235  
Fax  00917368261235  
Email  vishaldiwan@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Vishal Diwan 
Designation  Associate Professor  
Affiliation  Public Health and Environment  
Address  Public Health and Environment Ground Floor R D Gardi Medical College Agar Road Village Surasa Ujjain

Ujjain
MADHYA PRADESH
4560006
India 
Phone  00917368261235  
Fax  00917368261235  
Email  vishaldiwan@hotmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar New Delhi  
Type of Sponsor  Research institution 
 
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 
Anita Choudhary  R D Gardi Medical College  Department of Physiology Agar Road Village Surasa Ujjain- MP 456006
Ujjain
MADHYA PRADESH 
00917368261235

uctharc@sancharnet.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee R D Gardi Medical College (IEC-RDGMC) (ECR/1030/Inst/MP/2018)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Included:(1)age above 65yr(2)residents within 2 km from study site Excluded:(1)health/mobility problems that can interfere with training(2)severe cognitive deficits(3)current/recent practice of yoga 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group activity(Regular physical exercise)  Control Group participants will undergo 1 hour session twice in a week for 12 weeks, it will include mild regular exercises such as warm up movements, walking and stretching. If demanded by participants, they will be advised regarding how they can improve health behaviour by sitting less and standing/walking more throughout the day, where feasible. The rationale for including such control group, where participants are contacted with a similar frequency as the intervention group, is to reduce the likelihood of a Hawthorne effect. In this way, the control group will receive a similar frequency of ‘attention’ from the intervention.  
Intervention  Yoga  Yoga intervention will be done in a designate centre of R.D. Gardi Medical College by the team of trained team of Yoga instructors. Classes will be designed to be suitable for beginners and elderly, and include common yoga poses such as: knee presses, cow pose, bound angle, easy forward bend, twist with leg bent, half cobra and chair pose. Some balance exercises are also typically included, along with a focus on controlled breathing. Participants are encouraged to train at a level they find suitable while maintaining proper form, as instructed. The sessions will be of 1 hour and normally conclude with a 5 minute rest/relaxation period. Each class will be one hour long, and participants will be instructed to attend at least 2 sessions per week for 12-weeks. In addition, they will be encouraged to complete at least one additional yoga session at home, practicing what they learn at the center. Attendance will be monitored. Those who have not attended any classes for one week or more will be contacted by project team and will be encouraged to continue. Participants will also keep a diary where they note the number of sessions completed each day/week.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  (1) age (60+ years) and (2) residents with in two km from study centre. 
 
ExclusionCriteria 
Details  Exclusion criteria: (1) health or mobility problems that would interfere with yoga training (e.g. paralysis or inability to sit/stand); (2) severe cognitive deficits (e.g. dementia); and (3) current or recent (last 2 months) practice of yoga or regular (2 x per week or more) participation in other planned exercises, such as aerobics or strength training.  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to explore the effects of participation in a yoga-based exercise program on wellbeing  Pre-randomization
Post-intervention
6-month follow-up
 
 
Secondary Outcome  
Outcome  TimePoints 
to explore the effects of participation in a yoga-based exercise program on Health-related Quality of Life in older adults   Pre-randomization
Post-intervention
6-month follow-up
 
to explore the effects of participation in a yoga-based exercise program on Mobility and falls in older adults  Pre-randomization
Post-intervention
6-month follow-up
 
to explore the effects of participation in a yoga-based exercise program on depression in elder adutls  Pre-randomization
Post-intervention
6-month follow-up
 
to explore the effects of participation in a yoga-based exercise program on pain in elderly adults  Pre-randomization
Post-intervention
6-month follow-up
 
to explore the effects of participation in a yoga-based exercise program on cognition in elderly adults  Pre-randomization
Post-intervention
6-month follow-up
 
to explore the effects of participation in a yoga-based exercise program on physical activity in elderly adults  Pre-randomization
Post-intervention
6-month follow-up
 
to explore the effects of participation in a yoga-based exercise program on cardio-metabolic indicators,cortisol and inflammatory markers in elderly adults  Pre-randomization
Post-intervention
6-month follow-up
 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/09/2018 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Several scientific papers will be produced, starting with a study protocol. Proposed specific papers are as follows: Primary outcome paper (yoga and wellbeing),Cognition, Biological markers/mechanisms, Physical activity sedentary behaviour, Remaining secondary outcomes (Pain, sleep, depression and quality of life, mobility and falls).  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Most elderly adults do not meet the physical activity levels recommended for general health, which increases the risk for a variety of preventable health conditions. The aim is to improve the health and wellbeing of elderly adults through the practice of yoga-based exercises. Outcomes measured will include: wellbeing, health-related quality of life, cardio-metabolic risks, pain, physical activity and sedentary behaviour, mood states, mobility and falls, sleep quality, and cognition. Changes in cortisol and inflammatory markers will also be assessed.The world’s population is ageing and more people are living longer. At the same time, those that do live longer have more years lived with disease and disability. While many older adults enjoy good health, poor physical mobility, mood disorders, pain and cognitive deficits are common and have been linked to poor life quality. Regular physical activity can assist these health problems, yet most older adults are inactive. One possible reason is that conventional aerobic and strength exercises may not be feasible or appealing. The purpose of this project is to explore the effects of participation in a yoga-based exercise program on wellbeing (primary study outcome) in older adults. Effects of yoga on a range of secondary health outcomes will also be examined.

Randomized controlled trial is proposed to evaluate the effects of a 12-week yoga-based intervention to be implemented in India. About 150 participants will be recruited in Ujjain, India. Assessments will be taken at baseline (pre-randomization), post-intervention, and 6-month follow-up. The study is designed to empower elderly adults to initiate and continue the practice of yoga beyond the intervention. 

Classes will be designed to be suitable for beginners, and include common yoga poses such as: knee presses, cow pose, bound angle, easy forward bend, twist with leg bent, half cobra and chair pose. Some balance exercises are also typically included, along with a focus on controlled breathing. Participants are encouraged to train at a level they find suitable while maintaining proper form, as instructed. The sessions normally conclude with a 5 minute rest/relaxation period. Each class is one hour long, and participants will be instructed to attend at least 2 sessions per week for 12-weeks.  In addition,  they will be encouraged  to complete at least one additional yoga session at home, practicing what they learn at the center. Attendance will be monitored. Those who have not attended any classes for one week or more will be contacted by project team and will be encouraged to continue.

Control Group participants will undergo 1 hour session twice in a week for 12 weeks, it will include mild regular exercises such as warm up movements, walking and stretching. If demanded by participants, they will be advised regarding how they can improve health behaviour by sitting less and standing/walking more throughout the day, where feasibleThe rationale for including such control group, where participants are contacted with a similar frequency as the intervention group, is to reduce the likelihood of a Hawthorne effect. In this way, the control group will receive a similar frequency of â€˜attention’ from the intervention. 

 
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