| CTRI Number |
CTRI/2019/11/021869 [Registered on: 05/11/2019] Trial Registered Retrospectively |
| Last Modified On: |
05/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Exercise-Non pharmacological] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of exercise versus rest in myasthenia gravis |
|
Scientific Title of Study
|
Efficacy and safety of exercise in mild to moderate myasthenia gravis: an open
labeled controlled trial. |
| Trial Acronym |
RESTOREX MG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Usha Kant Misra |
| Designation |
Professor |
| Affiliation |
SGPGIMS Lucknow |
| Address |
Dept. of Neurology, SGPGIMS LUCKNOW
Dept. of Neurology, SGPGIMS
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222494167 |
| Fax |
05222668811 |
| Email |
drukmisra@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Kant Misra |
| Designation |
Professor |
| Affiliation |
SGPGIMS Lucknow |
| Address |
Dept. of Neurology, SGPGIMS LUCKNOW
Dept. of Neurology, SGPGIMS
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222494167 |
| Fax |
05222668811 |
| Email |
drukmisra@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Kant Misra |
| Designation |
Professor |
| Affiliation |
SGPGIMS Lucknow |
| Address |
Dept. of Neurology, SGPGIMS LUCKNOW
Dept. of Neurology, SGPGIMS
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222494167 |
| Fax |
05222668811 |
| Email |
drukmisra@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| World Congress of Neurology |
|
|
Primary Sponsor
|
| Name |
Prinicipal Investigator |
| Address |
Department of Neurology
SGPGIMS
Raebareli Road
Lucknow |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| World Congress of Neurology |
World Congress of Neurology India Trust, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PROF USHA KANT MISRA |
SGPGIMS LUCKNOW |
SGPGIMS RAEBARELI ROAD, LUCKNOW
Lucknow
UTTAR PRADESH |
05222494167
05222668811
drukmisra@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, SGPGIMS Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G700||Myasthenia gravis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise |
Exercise arm:
2-3 supervised walking sessions of 30 min., starting with 10 min. walking the
first week, 20 min. in second week and 30 min. in third week. After 4, 8 and 12 weeks of 30 min.
exercise the patients would be evaluated for the outcome
|
| Comparator Agent |
Rest |
Rest arm: They would be given 30 min rest in two sessions of 15 min each 6-8 h apart in which they would be advised to rest lying down in bed /couch /chair and may listen to music or any other relaxing activity |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. MG patients attending the neurology Outdoor or indoor services of SGPGIMS.
2. MGFA score of stage II to III.
3. Able to undergo 6minute walk test
|
|
| ExclusionCriteria |
| Details |
1. Enrolled in another trial. 2. Contraindications to exercise like coronary artery disease and stroke and pulmonary disease, osteoarthritis, pregnancy or medical condition reducing survival to less than 2 years.
3. Hospitalization in past 8 weeks. 4. MGFA score of stage I, IV or V. 5. MGQOL score > 45. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MGQOL-15 score |
1,2 and 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Increase in the dose of AchEIs drugs or additional immunosuppression or use of PE,IVIG.
2. Myasthenic muscle score: at 1,2 and 3 month.
3. Change in MGADL.
4. Grip strength.
5. Six min walk test.
6. RNS in Trapezius
7. Micro RNA: -150 -5P and micro RNA- 21- 5P.
8. Endorphin and its receptors. |
1,2 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/01/2019 |
| Date of Study Completion (India) |
20/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Myasthenia gravis (MG) is a rare autoimmune disease of neuromuscular junction. MG manifests with fatigability and fluctuating weakness of ocular, facial bulbar respiratory, axial and limb muscles.Exercise training is safe nonpharmacological intervention and may have physical and psychological advantages in MG. There is no randomised controlled trial on the efficacy and safety of exercise in MG .The present study is aimed at evaluating the efficacy and safety of exercise or rest in mild to moderate MG. |