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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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.
 
 
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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