| CTRI Number |
CTRI/2025/02/080061 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| 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
|
Effect of Sleep extension and relaxation on various outcomes in cricket player with hamstring strain |
|
Scientific Title of Study
|
Effectiveness of Combination of sleep extension and relaxation techniques on pain, attention,
relaxation and recovery outcomes in Cricket Players with hamstring strain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Chadha |
| Designation |
PG Scholar |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9250024469 |
| Fax |
|
| Email |
divyaachadha14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Bansal |
| Designation |
Asst. Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anu Bansal |
| Designation |
Asst. Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1
LGF Sector 125 Noida Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 201313 India |
|
|
Primary Sponsor
|
| Name |
Divya Chadha |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1
LGF Sector 125 Noida Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 201313 India |
| Type of Sponsor |
Other [other self] |
|
|
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 |
| Divya Chadha |
Amity Institute of Heal Allied Sciences |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH |
9250024469
divyaachadha14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Amity Institute of Health Allied Sciences Amity University Noida Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S763||Injury of muscle, fascia and tendon of the posterior muscle group at thigh level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sleep extension,Relaxation techniques and Rehabilitation Protocol |
The intervention agent in this study comprises a combination of sleep extension, relaxation
techniques, and a rehabilitation protocol. Participants in the experimental group are instructed to
extend their sleep duration by at least 2 additional hours per night, targeting a total of 10 hours
of sleep per night, with daily tracking in a sleep diary over the 6-week intervention period.
Alongside this, participants practice two relaxation techniques: deep breathing exercises and
progressive muscle relaxation (PMR). The deep breathing exercises are performed for 10
minutes per session, five days per week, focusing on diaphragmatic breathing to promote
relaxation and reduce stress. The PMR sessions last approximately 20 minutes per session,
also five days per week, systematically tensing each muscle group for 5–7 seconds followed by
relaxation for 20–30 seconds, progressing from head to toe. These relaxation techniques are
conducted under the supervision of a physiotherapist, primarily after training sessions, to
enhance relaxation and improve sleep quality. The rehabilitation protocol, included in both the
experimental and control groups, is conducted over three progressive phases spanning six
weeks. Each phase incorporates specific exercises tailored to the recovery stage of a Grade 1
hamstring strain: • Phase 1 (Weeks 1–2): Includes icing (2–3 times daily), stationary biking (10
minutes), side-step exercises (10 minutes, 3 × 1 minute), grapevine movements (10 minutes, 3
× 1 minute), prone body bridges (5 × 10 seconds), and supine body bridges (5 × 10 seconds).
Exercises are performed at low to moderate intensity and within a pain-free range. • Phase 2
(Weeks 3–4): Incorporates exercises such as rotating body bridges (5-second hold, 2 × 10
reps), supine bent knee bridges with walkouts (3 × 10 reps), lunge walks with trunk rotation (2 ×
10 steps per limb), and single-limb balance exercises with forward trunk lean (5 × 10 seconds
per limb), progressing to moderate intensity. • Phase 3 (Weeks 5–6): Focuses on
higher-intensity movements such as forward-backward accelerations (3 × 1 minute), rotating
body bridges with dumbbells (5-second hold per side, 2 × 10 reps), supine single-leg chair
bridges (3 × 15 reps), and single-limb balance windmill touches with dumbbells (4 × 8 reps per
arm).The total duration of such intervention will be 6 weeks |
| Comparator Agent |
Standard Rehabilitation Protoco |
The comparator agent in this study is the standard rehabilitation protocol, which is administered
to participants in the control group without additional sleep extension or relaxation techniques.
The rehabilitation protocol spans 6 weeks and is structured into three progressive phases,
designed to address the recovery needs of cricket players with Grade 1 hamstring strains: •
Phase 1 (Weeks 1–2): Low to moderate intensity exercises are performed to initiate recovery.
This includes icing (2–3 times daily), stationary biking (10 minutes), side-step exercises (10
minutes, 3 × 1 minute), grapevine movements (10 minutes, 3 × 1 minute), prone body bridges (5
× 10 seconds), and supine body bridges (5 × 10 seconds). • Phase 2 (Weeks 3–4): Exercises
progress in intensity to moderate levels, incorporating rotating body bridges (5-second hold, 2 ×
10 reps), supine bent knee bridges with walkouts (3 × 10 reps), lunge walks with trunk rotation
(2 × 10 steps per limb), and single-limb balance exercises with forward trunk lean (5 × 10
seconds per limb). • Phase 3 (Weeks 5–6): High-intensity exercises are introduced, including
forward-backward accelerations (3 × 1 minute), rotating body bridges with dumbbells (5-second
hold per side, 2 × 10 reps), supine single-leg chair bridges (3 × 15 reps), and single-limb
balance windmill touches with dumbbells (4 × 8 reps per arm).The total duration of such
intervention will be 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Male |
| Details |
•Inclusion:-
1.Male cricket players
2.Participating in Domestic Club Cricket
3.Cricket players in category U23, within age group of 19-23 years.
4.Having Grade 1 hamstring strain.
5.After evaluation of Athlete Sleep Screening Questionnaires {ASSQ} Category:-none (0-4)
6.Availability for rehabilitation protocol and sleep protocol with proper follow up.
Exclusion:-
1.Includes players having ASSQ of category: mild, moderate& severe i.e. score of 5-17
2.Sportsperson diagnosed with sleep disorders (e.g., insomnia, sleep apnea).
3.Sportsperson who are currently recovering from recurrent injuries or have fracture or
dislocation or any other pathology.
4.Players taking any kind of pain killers (NSAIDs, sedatives, etc)
5.Players consuming Alcohol
6.Players having certain type of injury (includes facial injury, upper limb injury, hip injury, knee
injury, ankle or foot injury, spinal cord injury)
7.Players suffering from any mechanical body pain or contusions or chronic conditions. |
|
| ExclusionCriteria |
| Details |
• Includes players having ASSQ of category: mild, moderate& severe i.e. score of 5-17
• Sportsperson diagnosed with sleep disorders (e.g., insomnia, sleep apnea).
• Sportsperson who are currently recovering from recurrent injuries or have fracture or dislocation or any other pathology.
• Players taking any kind of pain killers (NSAIDs, sedatives, etc)
• Players consuming Alcohol
• Players having certain type of injury (includes facial injury, upper limb injury, hip injury, knee injury, ankle or foot injury, spinal cord injury)
Players suffering from any mechanical body pain or contusions or chronic conditions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Pain Reduction 2. Recovery 3. Relaxation State 4. Attention Level 5. Sleep Quality |
baseline, Post sixth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
20/02/2025 |
| 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="0"
Months="3"
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 - 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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [divyaachadha14@gmail.com].
- For how long will this data be available start date provided 12-06-2025 and end date provided 11-05-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Background:- This trial investigates the impact of sleep extension and relaxation techniques on recovery outcomes for cricket players with Grade 1 hamstring strains. Hamstring strains are common in cricket due to high-speed sprints, sudden changes in direction, and intense physical exertion. These injuries not only cause physical limitations but also lead to psychological stress, which can disrupt sleep and hinder recovery. Sleep enhancement strategies, including sleep extension and relaxation, are increasingly recognized as crucial for muscle repair, inflammation reduction, pain management, and psychological well-being. This trial aims to examine whether combining sleep extension (additional two hours per night) and relaxation exercises (deep breathing and progressive muscle relaxation) with conventional rehabilitation can improve pain, attention, relaxation, and recovery outcomes. Purpose:-The primary purpose is to determine the effectiveness of these interventions in
speeding up recovery, reducing pain, and enhancing the mental state and performance of cricket players during their rehabilitation phase.
|