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
|
|
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
|
|
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 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. |