| CTRI Number |
CTRI/2025/07/090970 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Exercise Snacking] |
| Study Design |
Other |
|
Public Title of Study
|
In our study we will be including inactive young adults. We will be giving short duration exercises to see its effects on functional capacity and cognition. |
|
Scientific Title of Study
|
Effect of Exercise Snacking on Functional Capacity And Cognition In Inactive Young Adults: A Quasi-Experimental 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 |
Dr Harshita Asati |
| Designation |
postgraduate student |
| Affiliation |
MGM Institue of physiotherapy Aurangabad |
| Address |
Department of Cardiovascular and respiratory physiotherapy, MGM Institute of physiotherapy,Aurangabad
Aurangabad MAHARASHTRA 431003 India |
| Phone |
7038317160 |
| Fax |
|
| Email |
harshi.asati@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Santosh Dobhal |
| Designation |
Associate professor |
| Affiliation |
MGM Institute of physiotherapy Aurangabad |
| Address |
Department of Cardiovascular and respiratory physiotherapy, MGM Institute of physiotherapy,Aurangabad
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9923401079 |
| Fax |
|
| Email |
santoshdobhal@mgmiop.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Santosh Dobhal |
| Designation |
Associate professor |
| Affiliation |
MGM Institute of physiotherapy Aurangabad |
| Address |
Department of Cardiovascular and respiratory physiotherapy, MGM Institute of physiotherapy,Aurangabad
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9923401079 |
| Fax |
|
| Email |
santoshdobhal@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of physiotherapy N6 Cidco Aurangabad, 431003, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N6 Cidco Aurangabad, 431003, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Harshita Asati |
MGM Institute of Physiotherapy |
Department of Cardiovascular and Respiratory OPD No. 4, N6 Cidco 431003 aurangabad Aurangabad MAHARASHTRA |
7038317160
harshi.asati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
inactive young adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise Snacking |
exercise snacks(includes 10 exercise) sit to stand, standing knee bends,jumping jacks,march on spot,squats,seated leg kicks,lunges,standing calf raisesknee pushups, standing overhead arm raise will be given to inactive young adults ,3sessions/week for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged between 18-30 years.
2. Self- reported physical inactivity (less than150 minutes of moderate-to-vigorous physical activity per week). |
|
| ExclusionCriteria |
| Details |
1. Regular participation in physical exercise
2. Medical conditions restricting physical activity.
3. Obese (BMI more than or equal to 30 kg/m2)
4. Females who are pregnant. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Physical Activity- International Physical Activity Questionnaire
2.Functinal Capacity- Queens College Step Test
|
pre and post intervention period (week 8) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Congition - The Coginitive Failures Questionnaire 2.0 |
pre & post intervention period (week 8) |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="1" 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
|
Patients with low physical activity levels of age between 18 to 30 will be taken according to inclusion and exclusion criteria. Before collection of the data informed written consent will be taken from all the participants. The subjects will be interviewed and the information about demographic data of patients will be gathered and documented. Baseline data which include Functional capacity using queens college step test , physical activity assessed using International Physical Activity Questionnaire (IPAQ), Cognitive Function assessed using cognitive failures questionnaire ,Oxygen saturation and Heart rate using oximeter and Respiratory rate will be assessed. The patients will receive intervention for 8 weeks. the intervention group will receive exercise snacks. It include exercises Sit to Stand , standing knee bends, jumping jacks, march on spot, squats, seated leg kicks, lunges, standing calf raises, knee pushups, standing overhead arm raise will be given 5 sessions/week for 8 weeks. all participants will be receiving one session for 20 minutes per day. outcome measures will be assessed pre and post intervention period. statistical analysis of the collected will be done. Conclusion will be established based on the obtained results of the study. |