| CTRI Number |
CTRI/2022/12/048236 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
15/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Autonomic Nervous System and Physical Activity |
|
Scientific Title of Study
|
Influence of Exercise Intervention and Physical Activity on Autonomic Nervous System |
| Trial Acronym |
ANS and PA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogeshwari Raman |
| Designation |
Tutor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Tutor
Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
Porur
Chennai - 116
Plot no 23c, VGN Nagar,
Seneerkuppam,
Chennai.
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9994360164 |
| Fax |
|
| Email |
yogeshwaridinakaran@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogeshwari Raman |
| Designation |
Tutor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Tutor
Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
Porur
Chennai - 116
Plot no 23c, VGN Nagar,
Seneerkuppam,
Chennai.
TAMIL NADU
600116
India |
| Phone |
9994360164 |
| Fax |
|
| Email |
yogeshwaridinakaran@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Yogeshwari Raman |
| Designation |
Tutor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Tutor
Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
Porur
Chennai - 116
Plot no 23c, VGN Nagar,
Seneerkuppam,
Chennai.
TAMIL NADU
600116
India |
| Phone |
9994360164 |
| Fax |
|
| Email |
yogeshwaridinakaran@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
R Yogeshwari |
| Address |
Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research. Deemed to be university. porur .Chennai. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Priscilla Johnson HOD and Professor of Physiology |
Department of Physiology.
Sri Ramachandra Institute of Higher Education and Research. Deemed to be university. porur .Chennai |
| Guide Prof N Venkatesh Chairman |
Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research. Deemed to be university. porur .Chennai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RYogeshwari |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be university) |
Faculty of Physiotherapy
Udayar Block,
Sri Ramachandra Institute of Higher Education and Research (Deemed to be university)
Porur
Chennai-600116
Chennai
TAMIL NADU |
9994360164
yogeshwaridinakaran@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Research Ethics Committee, Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Autonomic system variations with no diagnosed comorbidities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Accumulated Physical Activity |
Modification of the occupational and recreational and leisure activities along with resistance exercises and aerobic exercises |
| Intervention |
High intensity exercises |
Participants exercises upto 70-85% of Vo2peak, for about 3days in a week for about 12 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with sedentary lifestyle having < 600 METS minutes /week
Subjects screened having more perceived stress in Perceived stress scale
|
|
| ExclusionCriteria |
| Details |
Subjects with Body Mass Index >30Kg/m2
Subjects with neurological, diabetes disorder, hypertensive, cardio-vascular disorders, autoimmune disorders, chronic renal disease, endocrine disorders,
Adults related with sports activities or regular physical activity with minimum of 150 min/ week
Subjects who have musculoskeletal problems that affects functional ability, low back pain, knee pain etc.,
Smokers, alcoholics, tobacco chewers
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Autonomic Function test and
Exercise capacity |
o weeks pre intervention and at 12 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Capacity |
o weeks pre intervention and at 12 weeks post intervention |
|
|
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)
|
01/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [yogeshwaridinakaran@sriramachandra.edu.in].
- For how long will this data be available start date provided 19-01-2024 and end date provided 19-01-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The aim of the study is to find out the effects of Accumulated physical activity Vs High intensity exercises on Autonomic nervous system in young sedentary adults. Based on the inclusion criteria the participants are recruited for the study and randomized into 3 group. The high intensity group receive exercises of about 70 to 85% of Vo2peak for about 3 days/weeks * 12 weeks. Initially they will be trained in the low intensity activity and progressed gradually to the high intensity activity. The exercises type includes the aerobic and resistance training exercises. The Accumulated physical activity group includes the activity done by their occupational related, leisure activities and the other activity done in a day for about 12 weeks. The exercises will be supervised in the physiotherapy department for about 1 day for the high intensity exercises and 2 days for the accumulated physical activity. Other group is the control group which receives the education about the importance of exercises. All the participants will undergo initial Autonomic function test, Perceived Stress Scale Questionnaire for stress, anthropometric measures, functional capacity and all will be repeated after 12 weeks of session. |