| CTRI Number |
CTRI/2025/10/095905 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| 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
|
Comparison of low intensity and moderate intensity aerobic exercise on sleep quality anxiety and quality of life in insomnia |
|
Scientific Title of Study
|
Comparison of low intensity and moderate intensity aerobic exercise on sleep quality anxiety and quality of life in insomnia among college students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ujala kumari |
| Designation |
MPT (Neurology) |
| Affiliation |
Sharda university |
| Address |
Department of Physiotherapy, plot no. 32 34, Knowledge park III, Greater Noida, Uttar Pradesh.
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9155432989 |
| Fax |
|
| Email |
ujaladwivedi217@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shivpriya Shrama (PT) |
| Designation |
Assistent Professor |
| Affiliation |
Sharda university |
| Address |
Department of physiotherapy, plot no. 32 34, Knowledge park III, Greater Noida, Uttar Pradesh.
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8860038070 |
| Fax |
|
| Email |
shivpriya.sharma@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ujala kumari |
| Designation |
MPT (Neurology) |
| Affiliation |
Sharda university |
| Address |
Department of Physiotherapy, plot no. 32 34, Knowledge park III, Greater Noida, Uttar Pradesh.
UTTAR PRADESH
201310
India |
| Phone |
9155432989 |
| Fax |
|
| Email |
ujaladwivedi217@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharda University, Department of Physiotherapy, plot 32 34, Knowledge park III, Greater Noida, Uttar Pradesh, 201310 |
|
|
Primary Sponsor
|
| Name |
Ujala Kumari |
| Address |
Department of Physiotherapy, Sharda University, plot 32 34, Knowledge park III, Greater Noida, Uttar Pradesh, 201310 |
| Type of Sponsor |
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 |
| Dr Ujala Kumari PT |
Sharda University |
plot no. 32 34, Knowledge park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9155432989
ujaladwivedi217@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: low intensity group |
Group 1: brisk walking, dynamic cycling ,jogging for 30-45min with MHR
|
| Comparator Agent |
Group 2:moderate intensity Aerobic group |
Group 2: brisk Walking, dynamic cycling, , jogging for 30-45 minutes with MHR
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 to 30 years, both male and female are included.
Sleep disturbance score by (ISI) score greater than 15 to 21
No active substance abuses.
Patients who are willing to participate
|
|
| ExclusionCriteria |
| Details |
Sever mental health disorder such as schizophrenia, bipolar disorder, severe depression
Pregnancy
Current participant in other intervention for insomnia
Severe anxiety and panic disorder
Physically inactive participant for intervention
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sleep Quality
Anxiety
Quality of life |
4 week and 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sleep Quality
Anxiety
Quality of life |
6 week |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A comparative study would be conducted at Department of physiotherapy, Sharda hospital over a period of 6 week involving a sample of young adults (18-30 years) recruited from university. After taking approval from Ethical Committee, participants will be selected randomly and screened for eligibility based on inclusion and exclusion criteria to ensure adequate representation of age groups. Written consent will be given to the participants, who volunteer themselves for the study and fulfill the inclusion and exclusion. Participants will receive a supervised exercise program for 6 week’s 3 days per week. The participants will split into 2 group, group A and group B. Group A will treat with low intensity aerobic exercise and Group B will treat with moderate intensity aerobic exercise. Participants in both low intensity and moderate intensity aerobic exercise group will receive exercise which include warm up (5minutes with 20% 30% MHR) 30 minutes of low or moderate aerobic exercises (brisk walk, dynamic Cycling jogging) cool-down 5 minutes.
|