| CTRI Number |
CTRI/2024/11/076300 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercises suitable for recreational cyclists |
|
Scientific Title of Study
|
Exploring the impact of mindfulness and yoga versus physiotherapy on physiological psychological and performance outcomes among recreational cyclists |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna Gupta |
| Designation |
PhD Scholar |
| Affiliation |
DPSRU |
| Address |
School of Physiotherapy,
Room no 610,
Delhi Pharmaceutical Sciences and Research University
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
9467791677 |
| Fax |
|
| Email |
aparnaa.gupta0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Kalra |
| Designation |
Guide |
| Affiliation |
DPSRU |
| Address |
Head of The Department
School of Physiotherapy,
Room no 610
Delhi Pharmaceutical Sciences and research university
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
9990003410 |
| Fax |
|
| Email |
sheetalkalra@dpsru.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Himani Shokhand |
| Designation |
senior consultant yoga (co-guide) |
| Affiliation |
DPSRU |
| Address |
68 ashoka road
new delhi
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
h8415shokhand@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aparna Gupta |
| Address |
H 52 ff the white house sector 57 gurugram
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Aparna Gupta |
Joyful fitness studio |
h.no-215, ground floor,
orchid island
Sector 51, Gurugram
Gurgaon
HARYANA |
9467791677
aparnaa.gupta0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DPSRU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male cyclists |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physiotherapy group |
5 mins warm up
20 mins core strengthening exercises (16 exercises; 8 for week 1,2,3 and next 8 for next weeks 4,5,6)
5 mins cool down
30 mins breathing exercises |
| Intervention |
Yoga and Mindfulness meditation |
30 mins yoga asanas.
30 mins mindfulness meditation.
handouts for reinforcement
six weeks study. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1. Cyclists between age 20-40 years who are interested in mindfulness research involving beginner yoga, cycling and physiotherapy.
2. Male cyclists.
3. Free from any musculoskeletal injury and neurological conditions that will affect their compliance to participate.
4. No history of surgery in last 6 months.
5. Participant should be cycling since 1 year at least.
6. Participant should be cycling for minimum1 hour for at least three days a week.
7. All cyclists should be using Triban 120 roadie.
8. Not participating in any other research. |
|
| ExclusionCriteria |
| Details |
1. Not willing to participate.
2. Female cyclists.
3. Any congenital disorder (such as scoliosis etc).
4. Any other cardiovascular and psychological pathology.
5. Any history of malignancy, tuberculosis and infective conditions.
6. Answering “yes†to any question on the PAR-Q
7. Participants should not be enrolled in gym or doing any extra training of any kind.
8. Participants should not be consuming any extra protein supplements. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EMG for vastus lateralis and rectus femoris |
BASELINE and post 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PANAS
Mindful Attention Awareness Scale (MAAS)
The resilience scale
Vertical jump test
Sit and Reach Test
Illinois Agility test
Time taken in covering 10 km cycle |
BASELINE and post 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
05/11/2024 |
| 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="0"
Months="6"
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
|
1) Impact of different types of bikes on post ride pain and insights into strategies adopted by recreational cyclists from Gurugram to alleviate pain : A cross sectional survey. Journal of clinical diagnostics and research 2) Biomechanical and postural evaluation of optimal bike fit for non traumatic injury prevention among cyclists : A narrative review. Journal of musculoskeletal research |