| CTRI Number |
CTRI/2025/04/085553 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Group v/s individual rehabilitation to improve the quality of sleep |
|
Scientific Title of Study
|
Comparing of efficacy of individual Tele rehabilitation supervised protocol and group Tele-rehabilitation supervised protocol in evaluation of the quality of sleep among healthy indivdiuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Chandigarh University |
| Address |
Department of Physiotherapy, UIAHS, Chandigarh University, Ludhiana-Chandigarh Highway,Gharaun (Mohali),Punjab
Ludhiana
PUNJAB
140413
India |
| Phone |
8427605504 |
| Fax |
|
| Email |
priyuarora8427@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Chandigarh University |
| Address |
Department of Physiotherapy, UIAHS, Chandigarh University, Ludhiana-Chandigarh Highway,Gharaun (Mohali),Punjab
PUNJAB
140413
India |
| Phone |
8427605504 |
| Fax |
|
| Email |
priyuarora8427@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Chandigarh University |
| Address |
Department of Physiotherapy, UIAHS, Chandigarh University, Ludhiana-Chandigarh Highway,Gharaun (Mohali),Punjab
PUNJAB
140413
India |
| Phone |
8427605504 |
| Fax |
|
| Email |
priyuarora8427@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chandigarh University, UIAHS, Ghuruan (Mohali), Chandigarh, Punjab, India-140413 |
|
|
Primary Sponsor
|
| Name |
Chandigarh University |
| Address |
Department of Physiotherapy, UIAHS Chandigarh University, Ghuruan (Mohali), Chandigarh, Punjab-140413 |
| Type of Sponsor |
Research institution |
|
|
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 Kalpana Chauhan |
Jaipur National University |
aipur National University,Jaipur-Agra Bypass, Near New RTO Office, Jagatpura, Jaipur, Rajasthan, India
Jaipur
RAJASTHAN |
9356148084
mnhumnhu53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep disturbances |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EXERCISE REGIMEN |
Exercise regimen consists of yoga, aerobic exercises, and resistance exercises via group tele-rehabilitation for 4 weeks. Each exercise will consist of 15 repetitions/set into two sets per day. |
| Comparator Agent |
Exercise regimen |
The exercise regimen consists of yoga, aerobic exercises, and resistance exercises for 4 weeks. Each exercise will consist of 15 repetitions/set into two sets per day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. The study comprised individuals of both genders.
2. The study comprised individuals between the 18 to 35-years.
3. The individuals who participated in this research were those whose PSQI baseline scores were less than 20 on a scale 38.
4. The individuals who could use an IOS mobile/ Laptop/Tablet or similar gadgets with a strong internet connection were included in the study. |
|
| ExclusionCriteria |
| Details |
1. The subjects excluded from the study had neurological conditions.
2. The subjects excluded from the study had musculoskeletal disorders and were unable to perform physical activity.
3. The subjects excluded from the study had cognitive impairments and a lack of self-control.
4. The subjects excluded from the study had a history of seizures. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pittsburgh Sleep Quality Index (PSQI)
Sleep Quality Scale (SQS) |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tele-health Satisfaction Survey (TeSS) |
4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/06/2025 |
| 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="5"
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
|
Sleep disruptions are a prevalent disorder that affects millions of individuals worldwide. The demanding schedules and sedentary lifestyles of these individuals are significant contributors to their poor sleep quality. Insomnia, cardiorespiratory disease, anxiety, and depression are all common outcomes of sleep deprivation. There are various sleep disorders, including insomnia, sleep apnea, restless limb syndrome, and narcolepsy, among others. Numerous factors have been investigated by researchers in this field as potential contributors to sleep disturbances. This prompted research into the causes of sleep disturbance and the development of effective interventions for treating and preventing sleep disorders. In virtue of these considerations, this study was designed to examine the impact of a supervised rehabilitation protocol on the sleep quality of healthy individuals. |