| CTRI Number |
CTRI/2025/03/082967 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Restless Leg Syndrome: Exercise versus Stretching |
|
Scientific Title of Study
|
Comparison between resistance exercises versus stretching exercises in patients with primary restless leg syndrome of Delhi- NCR- A comparative 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 |
Pooja Maharana |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
D block, Faculty of Physiotherapy, SGT University, Budhera, Gurugram, Haryana- 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9971075859 |
| Fax |
|
| Email |
poojamaharana1221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anushree Rai |
| Designation |
Assistant Professor |
| Affiliation |
Shree Guru Gobind Singh Tricentenary, Gurugram, Haryana- 122505 |
| Address |
D block, Faculty of Physiotherapy, SGT University, Budhera, Gurugram, Haryana- 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8937881164 |
| Fax |
|
| Email |
anushree.rai.21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anushree Rai |
| Designation |
Assistant Professor |
| Affiliation |
Shree Guru Gobind Singh Tricentenary, Gurugram, Haryana- 122505 |
| Address |
D block, Faculty of Physiotherapy, SGT University, Budhera, Gurugram, Haryana- 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8937881164 |
| Fax |
|
| Email |
anushree.rai.21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, SGT University, Gurugram, Haryana- 122505, India |
|
|
Primary Sponsor
|
| Name |
Pooja Maharana |
| Address |
D block, Faculty of Physiotherapy, SGT University, Budhera, Gurugram, Haryana- 122505 |
| 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 Anushree Rai |
Shree Guru Gobind Singh Tricentenary University |
D block, Faculty of Physiotherapy, SGT University, Budhera, Gurugram, Haryana- 122505
Gurgaon
HARYANA |
08937881164
anushree.rai.21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Resistance Training |
Resistance Training
30 minutes, 3 times a week for four weeks |
| Comparator Agent |
Stretching Exercises |
Stretching Exercises
30 minutes, 3 times a week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 65 years
IRLS rating score from mild to severe (0-30 points)
should meet the diagnostic criteria of IRLSSG
should be willing to participate |
|
| ExclusionCriteria |
| Details |
Subjects diagnosed with any neuropathy, renal failure, rheumatoid arthritis, iron deficiency anaemia
exposure of drugs which aggravate RLS- neuroleptics, dopamine receptor blocking agents, antidepressants, antihistamines
orthopedic condition that limits ambulation
pregnant women
unwillingness to continue the exercise sessions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. RLS severity score
2. Blood pressure
3. Heart rate variability |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Physical performance by STS-60 |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 2 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
Months="6"
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
|
The study compares the effects of resistance exercises and stretching exercises in adults with Primary Restless leg syndrome in Delhi-NCR. RLS is characterised by an uncontrollable urge to move the limbs, often worsening during rest or at night, and can lead to issues like anxiety, depression and cardiovascular problems. This research will involve dividing participants into two groups: one performing resistance exercises and the other focuses on stretching exercises . Both groups will follow a structured protocol for four weeks, with pre and post intervention measurements of RLS severity, cardiovascular fitness such as blood pressure and heart rate variability and physical performance. RLS severity will be tested by RLS severity scale, Blood pressure through sphygmomanometer, Heart rate variability through Polar H10 chest belt with Kubios software, and physical performance through STS-60. The study aim to determine which type of exercise is more effective in alleviating symptoms and improving health in individual with RLS. |