| 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
|
|
|
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
|
|
|
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. |