| CTRI Number |
CTRI/2021/11/037904 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find the effect of specific training program in recreational cyclists |
|
Scientific Title of Study
|
Effect of specific training program in recreational cyclists |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manali Kamleshbhai Shah |
| Designation |
PhD Student |
| Affiliation |
Gujarat University |
| Address |
L J OPD, L J Institute of Physiotherapy, L J Campus, Between Sarkhej circle and Kataria motors, SG road, Ahmedabad.
Ahmadabad
GUJARAT
382210
India |
| Phone |
9978391839 |
| Fax |
|
| Email |
mks3108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Megha Sheth |
| Designation |
Lecturer |
| Affiliation |
Gujarat University |
| Address |
SBB college of Physiotherapy, V.S. Hospital campus, Ellisbridge, Ahmedabad- 380006
Ahmadabad
GUJARAT
380006
India |
| Phone |
9879136035 |
| Fax |
|
| Email |
msheth2969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manali Kamleshbhai Shah |
| Designation |
PhD Student |
| Affiliation |
Gujarat University |
| Address |
L J OPD, L J Institute of Physiotherapy, L J Campus, Between Sarkhej circle and Kataria motors, SG road, Ahmedabad.
Ahmadabad
GUJARAT
382210
India |
| Phone |
9978391839 |
| Fax |
|
| Email |
mks3108@gmail.com |
|
|
Source of Monetary or Material Support
|
| LJ OPD, L J Institute of Physiotherapy, L J Campus, Between Sarkhej circle and Kataria motors, SG road, Ahmedabad. |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [NONE] |
|
|
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 |
| Manali Kamleshbhai Shah |
L J Institute of Physiotherapy |
L J OPD, L J Campus, Between Sarkhej Circle And Kataria Motors, SG Road, Ahmedabad- 382210
Ahmadabad
GUJARAT |
9978391839
mks3108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Jivraj Mehta Smarak Health Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anterior Knee Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
This group of participants will be advised for stretching and warm up before cycling and Ergonomic advice on cycle settings.
After 8 weeks outcome measures will be taken and will be compared whithin the group and between the group
|
| Intervention |
Specific Exercise training |
This group of participants will be given training for 3 days per week for 8 weeks, Stretching and warm up before cycling and Ergonomic advice on cycle settings.
Pre and post treatment outcome measures will be taken and compared within the group and between the group.
Training frequency: 3 days per week,
Training duration: 8 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Recreational cyclist with anterior knee pain (ranging from no pain to mild pain at present) during or after cycling
2. Cycling minimum 100 km/month
3. Cycling for minimum of 6 months or more
4. Age: 18 to 50 years
|
|
| ExclusionCriteria |
| Details |
1. Person having Knee pain with score more than or equal to 45mm on VAS.
2. Person diagnosed with Osteoarthritis of knee joint based on ACR Clinical classification criteria for Osteoarthritis of the knee
3. H/O any musculoskeletal disorder
4. H/O postural abnormality, limb length discrepancy
5. H/O cardiovascular or respiratory conditions
6. H/O neurological disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Anterior knee pain score (Kujala score)
2. Visual Analogue Scale |
8 weeks and follow up after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Core strength testing |
8 weeks |
| Q- angle measurement |
8 weeks |
| Lower limb flexibility tests |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2021 |
| Date of Study Completion (India) |
29/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Randomized, parallel group, active controlled trial, finding effect of 8 weeks specific training program on recreational cyclists with mild anterior knee pain during or after cycling, who are between 18 to 50 years of age and cycling for minimum of 100kms per month and for more than or equal to 6 months duration. The study will be performed at Ahmedabad, India. Interventional group will be given training for 3 days per week for 8 weeks, Stretching and warm up before cycling and Ergonomic advice on cycle settings and control group will receive ergonomic advice on cycle setting and advice to do stretching and warm up before cycling. The primary outcome measures will be Anterior knee pain score (Kujala score) for function and Visual Analogue Scale for intensity of pain at knee joint at 8 weeks and followed up telephonically at 6 months. The secondary outcomes will be Core strength testing, Q- angle measurement and Lower limb flexibility tests at 8 weeks. Pre and post treatment outcome measures will be taken and compared within the group and between the group. |