| CTRI Number |
CTRI/2021/08/036063 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Studies on Relationships Between Poor Balance and Sleep in Sedentary Youth |
|
Scientific Title of Study
|
Studies on Understanding the Relationship Between Poor Balance and Sleep in Sedentary Young Adult Population – A Cross Sectional Analysis |
| Trial Acronym |
S&B |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zubia Veqar |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Jamia Nagar, Okhla, New Delhi
Centre for Physiotherapy and Rehabilitation Sciences
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zubia Veqar |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Jamia Nagar, Okhla, New Delhi
Centre for Physiotherapy and Rehabilitation Sciences
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tarushi Tanwar |
| Designation |
PhD Scholar |
| Affiliation |
Jamia Millia Islamia |
| Address |
Jamia Nagar, Okhla, New Delhi
Centre for Physiotherapy and Rehabilitation Sciences
South
DELHI
110025
India |
| Phone |
9873852543 |
| Fax |
|
| Email |
tarushitanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Mohammed Ali Jauhar Marg, Jamia Nagar, New Delhi- 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Maulana Mohammad Ali Jauhar Marg
Jamia Nagar
Okhla
New Delhi - 110025 |
| Type of Sponsor |
Other [Central University] |
|
|
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 Zubia Veqar |
Room No 204, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
Maulana Mohammed Ali Jauhar Marg, Okhla
South
DELHI |
9958993486
veqar.zubia@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sedentary Young Adults, Sleep Related Problems, Balance Related Problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balance Improving Techniques – Sensorimotor Training |
The exercises will be conducted thrice a week (alternate days with gap not exceedingly more than 48 hours) for six weeks (total 18 sessions). Each session will comprise of 5 minutes of warm-up, followed by 25-30 minutes of exercise, followed by 5 minutes of cool down. Warm-up exercise will include cycle ergometer or treadmill at intensity of 40-50% maximal heart rate. Heart rate was monitored using heart rate monitor (Polar Electro, RS 400, Kempele, Finland). Sensorimotor training will comprise of wall slides, bridging exercises, prone plank, sit to stand, wobble board exercises, one leg stance, heel and toe raise, tandem stance which will be gradually progressed to different grades using unstable surface (Thera Band® Stability Trainer) (Ahmad I et al, 2020). Following the training session, subjects will perform cool-down exercises, which will include deep breathing, abdominal breathing and mild stretching. The participation in the exercise will be modified, postponed, or stopped based on the individual performance of the participants. Exercise progression will be made on the basis of a criteria which will help in deciding whether the participant is ready for progressing to the next phase of exercise or not. |
| Comparator Agent |
Sleep Hygiene Education |
The participants will be educated about good sleep hygiene and will be asked to practice the same in their daily life (Mastin DF et al., 2006). |
| Intervention |
Sleep Improving Techniques – Progressive Muscle Relaxation |
Jacobsen progressive muscle relaxation technique will be demonstrated and taught after ensuring that the participants understood about the technique.
A convenient place will be arranged in the in-patient department to demonstrate the progressive muscle relaxation technique. After participants will become familiar with performing the technique, they will be provided proper sessions by the same researcher.
Sequence of progressive muscle relaxation techniques:
Make them in a comfortable position (preferably sitting).
While beginning to tense the muscle group, the patients will be asked to feel the tension, but not so much that deal of pain, and to keep the muscle tensed for approximately 5 seconds.
Relax the muscles and keep it relaxed for approximately 10 to 15 seconds.
Followed by instruction, relaxation sequences will be demonstrated to the patients in three steps. In first and third steps of the relaxation sequence, the patients will be advised to begin the technique from right side of the body followed by left side (Ramasamy S, et al., 2018).
The technique will be conducted thrice a week (alternate days with gap not exceeding more than 48 hours) for six weeks (total 18 sessions). Participants will be instructed not to practice at home. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
For Prevalence Study:
Age between 18 - 29 years (Furtado et al., 2016).
Participants with working knowledge of English language in order to complete the questionnaires and sign the informed consent.
For Interventional Study:
Male participants.
Age between 18 - 29 years (Furtado et al., 2016).
Participants with working knowledge of English language in order to complete the questionnaires and sign the informed consent.
Sedentary individuals (Scoring a ‘low’ level of physical activity on the International Physical Activity Questionnaire).
Participants having poor balance (Normalized composite score ≤ 94% of limb length on Y-balance test measurements).
Participants having poor sleep quality (Score of ≥ 5 on the Pittsburgh Sleep Quality Index). |
|
| ExclusionCriteria |
| Details |
For Prevalence Study:
Participants suffering from any condition/disease/disorder that limits them from performing exercise and/or testing procedure.
Participants using therapies/treatments that may affect sleep patterns (e.g., diuretics, continuous positive airway pressure).
Participants suffering from any diagnosed psychiatric, musculoskeletal, neurological or cognitive, systematic, medical diseases/disorders or having any diagnosed orthopedic structural deformities.
Participants who underwent a physiotherapy treatment in the last six months.
Participants diagnosed with any visual, vestibular and/or somatosensory problems.
Participants using any orthosis or prosthesis.
Participants involved in sports-related activities on a regular basis.
For Interventional Study:
Participants suffering from any condition/disease/disorder that limits them from performing exercise and/or testing procedure.
Participants using therapies/treatments that may affect sleep patterns (e.g., diuretics, continuous positive airway pressure).
Participants suffering from any diagnosed psychiatric, musculoskeletal, neurological or cognitive, systematic, medical diseases/disorders or having any diagnosed orthopedic structural deformities.
Participants who underwent a physiotherapy treatment in the last six months.
Participants diagnosed with any visual, vestibular and/or somatosensory problems.
Participants using any orthosis or prosthesis.
Participants involved in sports-related activities on a regular basis. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Balance/Postural Control
Sleep |
Week 0 & Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Spinal Posture
Sleep Quality
Sleep Health
Sleep-Related Beliefs and Attitudes
Sleep-Related Quality of Life
Stress
Physical activity |
Week 0 & Week 6 |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| 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
Modification(s)
|
This study will shed light on the
prevalence of balance, posture, and sleep-related issues (sleep quality, sleep
health, sleep-related beliefs and attitudes, and sleep-related quality of life)
among young adults. In addition, the study will explore various predictors of
poor sleep in sedentary young adults. Determining the factors that may
influence sleep in this population will ultimately lead to a better
understanding of the issue and a more efficient solution. This study will determine the efficacy of postural control
and sleep-improving techniques on various parameters such as balance (COP, LOS,
CTSIB), sleep (objective sleep parameters, sleep health, sleep-related beliefs
and attitudes, sleep-related quality of life), stress and fatigue levels,
anxiety, and depression in young sedentary males with poor sleep and balance.
Poor sleep has been associated with significant physical and
mental health consequences. Poor balance has been linked to a higher risk of
falls and accidents. Exploring interventions that could improve sleep and
balance in this population will promote the overall health of sedentary young
adults and reduce the associated health risks. |