| CTRI Number |
CTRI/2024/06/069597 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [30 MIN WALKING] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of exercise (30 min walk) on Myasthenia Gravis patients. |
|
Scientific Title of Study
|
A study to assess the effectiveness of exercise (30 min walk) on Health-Related Quality of Life (HRQoL) among Myasthenia Gravis patients attending Neuro OPD at AIIMS, New Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Sah |
| Designation |
MSc. Nursing Student |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no.7 College Of Nursing, All India Institute of Medical Sciences, New Delhi
South West DELHI 110029 India |
| Phone |
7568751897 |
| Fax |
|
| Email |
nehasah1704@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ms. Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 7, College Of Nursing, All India Institute of Medical Sciences, New Delhi
South West DELHI 110029 India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Neha Sah |
| Designation |
MSc. Nursing Student |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 7, College of Nursing, All India Institute of Medical Sciences, New Delhi
South West DELHI 110029 India |
| Phone |
7568751897 |
| Fax |
|
| Email |
nehasah1704@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, pin code- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
College of Nursing, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, pin code- 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepti Vibha |
All India Institute of Medical Sciences, New Delhi |
7th Floor, Room no. 707 Neurology Department, Cardio Neuro Centre , All India Institute of Medical Sciences, New Delhi, 110029 South West DELHI |
9968859848
deeptivibha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
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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 |
30 MIN WALKING |
Pre Test will be done by checking the baseline MGQoL-15 and MGADL score.
Patients will be asked to walk for 10 min in a straight corridor infront of the researcher in the first visit, then the patient will be instructed to engage for 20 min walk in the second week and 30 min walk in the third week till the 4th week thrice a week.
A log Book will be provided to keep a track of compliance to therapeutic exercise program.
Post Test after 4 weeks through MGQoL-15 score.
Statistical Analysis and Comparison will be done.
Total Duration: 20-30 min |
| Comparator Agent |
standard care |
Pre Test will be done by checking the baseline MGQoL-15 and MGADL score.
Conventional treatment will be given as per the Institutes protocol
Post test will be taken after 6 weeks through MGQoL-15 score.
Statistical Analysis and Comparison
Total Duration: 20-30 min |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Myasthenia Gravis patients attending Neurology OPD at AIIMS, New Delhi.
2 MG patients who are willing to participate in the study.
3 MG patients who are able to follow commands and instructions.
4 MG patients with MG (MGFA class 2 and 3 ) and able to undergo 6 min walk test(6MWT).
5 MG patients who have the access of smart phone or smart watches.
|
|
| ExclusionCriteria |
| Details |
1 MG patients who are walking for more than 150 min per week.
2 Any contraindication to exercise.
3 MG patient with other co-morbid conditions.
4 Physically disabled MG patients.
5 MG patients who are not able to communicate in Hindi or English.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the effectiveness of exercise(30 min walk) on health-related quality of life (HRQoL) of MG patients. |
before and after 4 weeks of intervention or standard care provided to the patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the effect of exercise (30 min walk) on activities of daily living of MG patient.
To find out the association between MG-QoL & selected demographic variables
|
after 4 weeks of intervention or standard care provided to the patients |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
08/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" 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
|
NEED FOR STUDY
It
has been suggested that clinically stable MG patients, just like healthy
individuals, should be able to reap the benefits of physical exercise.A regime
of moderate exercise for 30 min a week has a positive impact on ADLs of MG
patients. It has been seen in many studies that exercise programs have widely
shown improvement in muscular and physical function. But, effectiveness of
exercise programs in improvement of health related quality of life (HRQoL) had
not been established so far. As far as researcher’s knowledge goes few studies
have been done but it is widely scattered and generalization cannot be made so,
it is done to strengthen the literature. AIM OF THE STUDY
To evaluate whether a exercise
(30 min walk) could improve health-related quality of life (HRQoL) of MG
patients. PRIMARY OBJECTIVES
To access the effectiveness of
exercise(30 min walk) on health-related quality of life (HRQoL) of MG patients.
SECONDARY OBJECTIVES
1.
To find out the effect of exercise
(30 min walk) on activities of daily living of MG patient.
2. To find out the association between MG-QoL and selected demographic
variables METHODOLOGY
Research approach– Quantitative approach
Research design- Randomised Control Trial
Independent variable
Exercise
(30 min walk)
Dependent variables
•
HRQoL
•
MGADLs Setting of the study– Neuro OPD, AIIMS, New Delhi
Population--
patients with generalized and stable Myasthenia Gravis
Sample Size- Myasthenia Gravis patients
attending Neuro OPD at AIIMS, New Delhi.
Sampling Technique- Purposive Sampling technique with random allocation.
Inclusion criteria
•
Myasthenia
Gravis patients attending Neurology OPD at AIIMS, New Delhi.
•
MG patients who
are willing to participate in the study.
•
MG patients who
are able to follow commands and instructions.
•
MG patients with
MG (MGFA class 2 and 3 ) and able to undergo 6 min walk test(6MWT).
•
MG patients who
have the access of smart phone or smart watches.
MGFA: Myasthenia gravis
foundation of America Classification
•
Class II- Mild weakness affecting
other than ocular muscles
- IIa) Predominantly
affecting limb or axial muscles or both
- IIb) Predominantly
affecting oropharyngeal or respiratory muscles or both
•
Class III- Moderate weakness
affecting other than ocular muscles
- lla) Predominantly affecting limb or axial
muscles or both
- llb) Predominantly
affecting oropharyngeal or respiratory muscles or both
Exclusion
criteria
•
MG patients who are walking for more than 150 min per week.
•
Any contraindication to exercise.
•
MG patient with other co-morbid
conditions.
•
Physically disabled MG patients.
•
MG patients who are not able to communicate in Hindi or
English.
Data
collection tool and techniques
Tool 1: Socio-demographic
variable performa (Subject data sheet including Clinical profile)
Tool 2: MGQoL-15:15-item MG-specific quality of life scale.
Tool 3: MG Activities of Daily Living (MGADL) score.
PILOT STUDY
•
Pilot study will be done in June 2024 to check the
feasibility of the study.
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