| CTRI Number |
CTRI/2025/08/092458 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on effectiveness of exercise on sleep quality of older people. |
|
Scientific Title of Study
|
Assess the effectiveness of restorative stretching for quality of sleep among elderly. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Rohini A Kakde |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Dept. of Mental Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9518708518 |
| Fax |
|
| Email |
rohinikakde1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Kasturkar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Dept. of Mental Health Nursing, Ground Floor, SRMMCON Budling, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9673886027 |
| Fax |
|
| Email |
poojakasturkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Kasturkar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Dept. of Mental Health Nursing, Ground Floor, SRMMCON Budling, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9673886027 |
| Fax |
|
| Email |
poojakasturkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India- 442001. |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India - 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Pooja Kasturkar |
Smt. Radhikabai Meghe Memorial Collage of Nursing |
Dept. of Mental Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9673886027
poojakasturkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Old age individuals will be given restorative stretching exercises and pre and post assessment will be done for sleep quality. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Restorative Stretching exercises |
Restorative Stretching exercises will be explained. The pre and post sleep quality assessment will be done. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.The elderly who are present on the day of data collection.
2.The elderly who can read and understand English or Marathi.
3.The elderly who are able to perform restorative stretching with minimal assistance.
|
|
| ExclusionCriteria |
| Details |
1.The elderly has participated in similar type of project. Last 6 month.
2.The elderly who are mentally ill.
3.The elderly who are having Severe cardiovascular, respiratory, or neurological conditions that limit physical activity, arthritis and fracture.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of quality of sleep in old individuals with restorative stretching exercises. |
Assessment will done within a four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="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
|
This study assesses the effectiveness of restorative stretching in improving sleep quality among the elderly. Restorative stretching, a gentle form of physical activity focused on muscle relaxation and flexibility, was introduced as a non-pharmacological intervention for older adults experiencing sleep disturbances. Participants engaged in guided stretching sessions over a set period, with pre- and post-intervention sleep quality measured using validated tools such as the Pittsburgh Sleep Quality Index (PSQI). Findings indicate a significant improvement in sleep duration, latency, and overall restfulness, suggesting that restorative stretching is a beneficial, low-risk method for enhancing sleep quality in the elderly population. |