| CTRI Number |
CTRI/2026/01/101393 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| 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
|
Effect of Combined Exercise on Pain, Balance, Sleep, Memory, Anxiety, and Quality of Life in Elderly Indians with Restless Legs Syndrome |
|
Scientific Title of Study
|
EFFICACY OF MULTIMODAL EXERCISE INTERVENTION ON PAIN, BALANCE, SLEEP QUALITY, COGNITIVE FUNCTION, ANXIETY LEVELS AND OVERALL QUALITY OF LIFE FOR RESTLESS LEG SYNDROME IN INDIAN ELDERLY POPULATION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Loge Ngomle |
| Designation |
PG Student |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
room no. 418 4th floor department of physiotherapy B block Gurugram Haryana 122505 India
New market Daporijo, Upper Subansiri District, Arunachal Pradesh
Gurgaon
HARYANA
122505
India |
| Phone |
7085685172 |
| Fax |
|
| Email |
logengomle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Loge Ngomle |
| Designation |
PG Student |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
room no. 418 4th floor department of physiotherapy B block Gurugram Haryana 122505 India
New market Daporijo, Upper Subansiri District, Arunachal Pradesh
Gurgaon
HARYANA
122505
India |
| Phone |
7085685172 |
| Fax |
|
| Email |
logengomle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Gakhar |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
4th floor department of physiotherapy B block Gurugram Haryana 122505 India
Gurgaon
HARYANA
122505
India |
| Phone |
9871863033 |
| Fax |
|
| Email |
himanshu.gakhar_fphy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Loge Ngomle |
| Address |
Satpal Boys PG, near SGT Hospital,Chandu Budhera Road,Gurugram, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Loge Ngomle |
SGT Hospital |
Physiotherapy OPD, room number-13
Gurgaon
HARYANA |
7085685172
logengomle@gmail.com |
| Loge Ngomle |
SLOAH Senior care home |
Plot no. 47 & 47A, dwarka vihar, kakrola road, Dwarka, New Delhi, 110043
New Delhi
DELHI |
7085685172
logengomle@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 |
| Healthy Human Volunteers |
EFFICACY OF MULTIMODAL EXERCISE INTERVENTION ON PAIN, BALANCE, SLEEP QUALITY, COGNITIVE FUNCTION, ANXIETY LEVELS AND OVERALL QUALITY OF LIFE FOR RESTLESS LEG SYNDROME IN INDIAN ELDERLY POPULATION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Structured Multimodal Exercise Intervention Protocol for Restless Legs Syndrome in Elderly Indians- A 4-week protocol. |
The intervention protocol is given for 45-50 minutes for 4 weeks.
The intervention which given to the subject is structured multimodal exercises (strengthening, aerobic, foot massage, stretching exercise, trauma release exercise, balance exercise, relaxation) including warmup and cooldown after every exercise session.
The exercise protocol is calibrated and tailored as per the needs, comfort of the patient, the exercise based upon the guidelines given by ACSM principle of exercises protocol Frequency, Intensity, Type, Time, volume and Progression (FITT-VP),
Geriatric Society.
The above exercise protocol for the experimental and control groups will be progressed based on the patient’s improvement. The exercise dosage may be increased or decreased according to the patient’s condition and tolerance. |
| Comparator Agent |
Active control Group |
Trauma Release exercise
Calf raise, ankle pronation/supination, ankle toe pump , lumbar rotation exercise and spinal extension exercise, for 45-50 minutes per session, 4 session per week, for 4 week. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
People who have already been diagnosed with restless leg syndrome (RLS) by a physician or doctor.
Screening criteria that meet all five of the International Restless Leg Syndrome Study Group Rating Scale (IRLS)
Urge to Move the Legs.
Symptoms Triggered or Worsened by Rest/Inactivity.
Relief with Movement.
Worse in the Evening or Night.
Neither these symptoms nor those of other disorders are the primary markers of the sickness.
RLS symptoms at least once a week in the past 3 months.
By using the Karnofsky Performance Status (KPS) Scale on RLS in Elderly Individuals, included only those individual functional status and ability to perform daily activities Equal to or more than 70 percent.
Ability to walk for 3 meters distance.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
The person with uncontrolled hypertension.
The person with diagnosed with sleep apnea or with diabetes, cancer, heart failure or serious chronic disorder.
The person with any orthopedic, neurological, or other condition that might prevent them from safety completing exercise program
Ongoing antipsychotic medication
Recently diagnosed with renal disease, anemia, neuropathy, RA.
Patients diagnosed with Parkinson disease.
Pregnant women or within 6 months postpartum
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain measured by Short form McGill Pain Questionnaire (SF-MPQ)
2.Balance measured by
I. Dynamic Balance Test: Measured by Time Up and Go Test (TUG)
II. Static Balance Test: Unipedal Stance Test
3.Sleep quality measured by Measured by Pittsburgh Sleep Quality Index (PSQI)
4.Restless leg syndrome measured by International Restless Leg Syndrome Study Group Rate Scale (IRLS)
|
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Cognitive Function measured by Mini-Mental State Examination (MMSE)
2.Anxiety Levels Measured by Hospital Anxiety and Depression Scale (HADS-A)
3.Overall Quality of Life is measured by SF-36 Questionnaire
|
Baseline and 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
27/01/2026 |
| 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="1"
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
|
Efficacy of multimodal exercise intervention on pain, balance, sleep quality, cognitive function, anxiety levels and overall quality of life for restless leg syndrome in Indian elderly population.
The study highlights that although exercise is known to improve sleep and well-being, research specific to Indian elderly with RLS is limited. Therefore, this research aims to determine whether a structured multimodal program—combining strengthening, aerobic training, stretching, balance exercises, foot massage, and relaxation—can improve pain, balance, sleep quality, cognitive function, anxiety levels, and overall quality of life. This will be an experimental pre–post controlled study involving participants aged 65+ already diagnosed with RLS, screened using IRLSSG criteria and KPS. The intervention will run for 4 weeks with regular supervised exercise sessions. Outcomes will be assessed using validated tools such as International Restless Leg Syndrome Study Group Rating Scale (IRLS), Pittsburgh Sleep Quality Index (PSQI), Shor form McGill Pain Questionnaire (SF-MPQ), TUG and Berg balance Scale (BBS), Mini-Mental Scale Examination (MMSE), Hospital Anxiety and Depression Scale (HADS), SF 36, karnofsky Performance Status (KPS) Scale, etc. The study expects that multimodal exercise will significantly reduce RLS symptoms and enhance functional, psychological, and sleep-related outcomes in the elderly population. |