| CTRI Number |
CTRI/2024/05/067876 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of self stretching before sleep on night leg cramps pain and quality of sleep in older adults |
|
Scientific Title of Study
|
Effect of self stretching before sleep on nocturnal leg cramps pain and sleep quality among older adults- A Quasi Experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Sanjay Malpani |
| Designation |
Intern |
| Affiliation |
Dr.Ulhas Patil College Of Physiotherapy, Jalgaon |
| Address |
Physiotherapy OPD 207 khirdi shivar Tal and Dist Jalgaon, Maharashtra
425309
India
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
7218696281 |
| Fax |
|
| Email |
sakshii2805m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Shinde |
| Designation |
Assistant Professor |
| Affiliation |
Dr.Ulhas Patil College Of Physiotherapy, Jalgaon |
| Address |
Physiotherapy OPD 207 khirdi shivar Tal and Dist Jalgaon, Maharashtra
425309
India
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
9021047555 |
| Fax |
|
| Email |
mukeshshinde31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Shinde |
| Designation |
Assistant Professor |
| Affiliation |
Dr.Ulhas Patil College Of Physiotherapy, Jalgaon |
| Address |
Physiotherapy OPD 207 khirdi shivar Tal and Dist Jalgaon, Maharashtra
425309
India
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
9021047555 |
| Fax |
|
| Email |
mukeshshinde31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Ulhas Patil College of Physiotherapy, Khirdi Shivar NH 06, Tal and Dist. Jalgaon
425309 |
|
|
Primary Sponsor
|
| Name |
Sakshi Sanjay Malpani |
| Address |
Dr. Ulhas Patil College of Physiotherapy, Jalgaon |
| 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 Mukesh Shinde |
DR. ULHAS PATIL MEDICAL COLLEGE AND HOSPITAL |
Physiotherapy OPD 207, Dr.Ulhas Patil College of Physiotherapy , NH 06, khirdi shivar, Tal and Dist Jalgaon, Maharashtra
Jalgaon
MAHARASHTRA |
9021047555
mukeshshinde31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr. Ulhas Patil College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Self stretching exercises of hamstrings, calf and foot muscles. |
Self Stretching exercises include Hamstring stretching in supine, Calf stretching in long sitting and Heel raise in standing.
Dosage- 1 set of 3-5 repetitions with 10 sec hold and 5 seconds of relaxation between each stretch. Stretching of both legs will be done for 6 days/wk for 3weeks. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who experiencing regular episodes of Nocturnal Leg Cramps, Having no specific pathology involved. |
|
| ExclusionCriteria |
| Details |
Subjects with musculoskeletal problems, several medical conditions or comorbidities known to cause muscle cramps or spasm, Any vascular disorder of lower limb, Person using quinine or any medication to assist sleep, Person who is not willing to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale (NPRS),
Pittsburgh sleep quality index (PSQI) |
At baseline, 3weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
17/06/2024 |
| 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="0"
Days="21" |
|
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
|
Permission from Institutional ethical committee will be taken. Subjects will be selected according to the inclusion and exclusion criteria by convenient sampling Technique. Total 47 subjects will be include in the study. A written informed consent will be taken from subjects who are willing to participate. Procedure, aim and objective will be thoroughly explained to the subjects selected for the study. Earlier the demographic data, History of nocturnal leg cramps of each and every individual will be taken. Pre treatment evaluation of Numerical pain rating scale( NPRS) ,Pittsburgh Sleep Quality Index (PSQI) will be done before initiating the treatment and Post treatment evaluation will be again assessed after the treatment, i.e. after 3weeks. Self Stretching of hamstring and calf combine with Heel raise exercises will be taught to the subjects. Stretching of both legs will be done for 6 days/week for 3 weeks. Post treatment response of all participants of nocturnal leg cramp pain and sleep quality will be noted. |