FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075899 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Intermittent short duration exercises]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of intermittent exercise on cardiac and metabolic health of inflammatory myositis patients 
Scientific Title of Study   Effectiveness of exercise snack (short duration vigorous intermittent physical activity) on cardiovascular and metabolic parameters in Inflammatory myopathy: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rizwana Naushad 
Designation  Academic Senior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER 
Address  Clinical Immunology Department; 4th floor, Super Speciality Block, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8547568699  
Fax    
Email  rizwananshd44@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Molly Mary Thabah 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER 
Address  Clinical Immunology Department,4th floor, Super Speciality Block, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8903200854  
Fax    
Email  mollymthabah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rizwana Naushad 
Designation  Academic Senior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) 
Address  Clinical Immunology Department; 4th floor, Super Speciality Block,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8547568699  
Fax    
Email  rizwananshd44@gmail.com  
 
Source of Monetary or Material Support  
JIPMER intramural grant Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry,India Pin : 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Puducherry 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) Dhanvantari Nagar Gorimedu Puducherry 605006 India  
Type of Sponsor  Government medical college 
 
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 Rizwana Naushad  Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)  Clinical Immunology Department; 4th floor, Super Speciality Block, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)Puducherry
Pondicherry
PONDICHERRY 
8547568699

rizwananshd44@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(Human studies) for Intervention studies, JIPMER, Puducherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M33||Dermatopolymyositis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise snack   Short duration vigorous intermittent physical activity- Each exercise session will consist of a brief warm up and a bout of body weight-based exercise. Repeated training sessions will be conducted once in 4 weeks (at 0, 4 and 8 weeks) for each of the patients in the intervention group till they complete 12 weeks. Exercises include skipping without rope, standing bicycle crunches and chair squat jumps. The patient will be required to do these exercises a minimum of 3 times a day for 3 days/week to a maximum of 3 times a day for 5 days/week 
Comparator Agent  Standard of care  The usual medical treatment related to the myositis disease will be maintained throughout the timeline of the study for both groups as per the treating physician’s decision. Patients will be instructed to maintain the level of physical activity at the same level as prior to initiation of the study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients aged 18 to 65 years with idiopathic inflammatory myopathies (IIM) satisfying EULAR ACR 2016 classification criteria for IIM
2.On stable dose of immunosuppression and glucocorticoids for 2 consequent visits 3 months apart
3.Muscle disease and extra muscular disease physician global assessment visual analogue score (VAS) is 0 at least on 2 consequent visits 3 months apart.
 
 
ExclusionCriteria 
Details  1.Patients with coexisting myocarditis, endocarditis and pericarditis with symptoms severity of New York heart association (NYHA) 2 or above
2.Patients with malignancy.
3.Patients with severe ILD with dyspnea of Medical research council (MRC) grade 2 or above
4.Patients with diagnosed coronary artery disease, peripheral arterial disease or stroke.
5.Room air desaturation at rest 85% or less
6.Symptomatic pulmonary hypertension or WHO functional class II or above.
7.Vulnerable group of patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To compare the change in cardiorespiratory fitness measured by Peak oxygen consumption (ΔPVo2max) between those receiving exercise intervention and those receiving standard care in IIM.  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To see the effectiveness of exercise intervention on lipid profile, insulin resistance, and body composition in IIM  12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   02/12/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Patients with idiopathic inflammatory myositis (IIM) who are in clinical remission, on stable dose immunosuppressants, are under follow up and regular care  in the department of Clinical Immunology OPD will be screened for eligibility. If the patients satisfy the inclusion criteria and provide written informed consent, they will be enrolled into the trial. 

Baseline clinical information namely age/sex, type of IIM, duration of IIM disease, disease manifestation (arthritis, cutaneous signs, interstitial lung disease), and myositis specific antibodies, myositis associated antibodies will be recorded. The disease activity measures as determined by manual muscle testing 8 (MMT8), Physician and Patient global assessment, extra muscular disease activity, health assessment questionnaire (Indian version), and muscle pain using visual analogue scores will be measured at baseline and after 12 weeks.  

Eligible participants idiopathic inflammatory myositis (IIM) satisfying the inclusion and exclusion criteria  will be randomised in to exercise snack group and standard care group. 

Exercise snack group (ESG) will receive exercise snacks in addition to the standard care, whereas the standard care group (SCG) include will receive only standard care. 

After the randomisation process, those assigned to ESG group (intervention) will be taught the required exercise by the investigator.  Each exercise session will consist of a brief warm up and a bout of body weight-based exercise. Repeated training sessions will be conducted once in 4 weeks (i.e. at 0, 4 and 8 weeks) for each of the patients in the intervention group till they complete 12 weeks. The exercise consists of: Warm-Up i.e., basic mobility exercises for 1minute. Main exercises include skipping without rope, standing bicycle crunches and chair squat jumps. The patient will be required to do these exercises a minimum of 3 times a day for 3 days/week to a maximum of 3 times a day for 5 days/week. Standard of care will be continued in both the groups. Patients will be instructed to maintain the level of physical activity at the same level as prior to initiation of the study and will be assessed using the international physical activity questionnaire. 

To ensure compliance, each patient will be contacted telephonically and the frequency, duration of exercises done every week will be recorded. Diaries and a customised checklist will be supplied to patients where they can mark the events(exercise sessions) performed every week. The diaries/checklists will be reviewed at the end of 4 weeks, 8 weeks, and at 12 weeks (part of regular visits). Each visit for availing regular medications will be utilised to ensure compliance (by showing videos). Only those individuals who will perform at least 9 sessions of exercise per week will be considered as compliant.

1. VO2max will be measured by cardiopulmonary exercise testing in both the groups at baseline i.e., at the time of randomisation and at the end of 12 weeks. VO2 max test will be performed on an ergometer bicycle starting at 30–40W, and the required power output will be increased by 10W every minute. VO2 max will be determined by incremental cycling to exhaustion. Pulmonary minute ventilation and gas exchange (O2 uptake and CO2 output, respectively) would be measured breath by breath. The VO2 max will be calculated using Astrand (unconditioned) protocol which is based on a linear relationship between mechanical load, oxygen uptake and heart rate (HR) obtained during the test.

2. Venous blood samples (after overnight fasting) will be collected from participants in both groups (exercise and SCG) at baseline and 12 weeks  for testing the lipid profile (total cholesterol, low density lipoproteins, high density lipoproteins and triglycerides); Fasting blood glucose and serum Insulin will be measured and insulin resistance will be calculated using Homeostatic Model Assessment for Insulin Resistance (HOMA IR) 2 model using online tool.

3.The fat and lean body mass will be assessed using dual-energy X-ray absorptiometry (DXA) at baseline and after 12 weeks for participants in both groups. 

 
Close