| CTRI Number |
CTRI/2020/01/022990 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exosomes in PAH with and without exposure to exercise |
|
Scientific Title of Study
|
Exosomes in pulmonary arterial hypertension with and without the exposure to exercise |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abraham Samuel Babu |
| Designation |
Associate Professor |
| Affiliation |
MCHP, Manipal |
| Address |
Dept of Physiotherapy, MCHP, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
abraham.babu@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmakumar R |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Dept of Cardiology, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
padmakumar69@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmakumar R |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Dept of Cardiology, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
padmakumar69@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indian council of Medical Research (ICMR)
V.Ramalingaswami Bhawan, Ansari Nagar, P.Box No. 4911,
New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V Ramalingaswamy Bhawan, P.O. Box no.-4911, Ansari Nagar, New Delhi-110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Abraham Samuel Babu |
MAHE |
Dept of Cardiology and Physiotherapy, MAHE , Manipal - 576104
Udupi
KARNATAKA |
9742502838
abraham.babu@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I270||Primary pulmonary hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control |
standard medical treatment and patient education using Pulmonary Hypertension Manual (PulHMan) through one-to-one session. They will be adviced to adhere to the advice given by the physician and the manual. There will be no contact till 12 weeks |
| Intervention |
exercise |
in addition to the standard medical treatment and patient education via the Pulmonary Hypertension Manual (PulHMan), they shall also receive an individualized, structured, home-based program. This will include a 5 minute warm up session which includes breathing exercise, hand exercise, heel raises, tendo-achilles and hamstring stretches. This is followed by the exercise phase comprising of active exercises for bilateral upper limb joints (i.e., shoulder flexion, abduction, elbow flexion with shoulder in 90 degree flexion) lower limbs (i.e., hip flexion and abduction in standing, quadriceps exercise), trunk rotations and bridging. After which patients will be adviced to walk for 5-10 minutes with RPE between 4-6/10 or 12-13/20 initially, followed by gradual progression in time. At the end of the exercise session, they will be adviced to perform a cool down of 5-10 minutes which would include the same exercises as warm up. The intensity for active exercises is initially set at 5 reps with 1-2 sets for upperlimb and 2-3 sets for lower limb followed by progression in both sets and reps and weights, every two weeks. The walking intensity is set based on the heart rate response and intensity attained during the 6 minute walk test, done at baseline. Each exercise session will last for 10-20 minutes, initially, to progress to around 30-40minutes a day by the end of 12 weeks. With each progression, the exercise intensity will be maintained at the RPE between 4-6/10 or 12-13/20. This shall be achieved by telephonic monitoring done by the investigator every fortnight. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed with Pulmonary Hypertension (PH) of Group 1 (acc. to
WHO classification) and any functional class, stable on medical therapy for 2 months and having a tricuspid regurgitation velocity ≥3.4m/s with or without right ventricular dysfunction, detected on transthoracic echocardiography
For the purpose of metabolomics, a discovery group comprising of 10 healthy age matched controls, free of co-morbidities shall be recruited |
|
| ExclusionCriteria |
| Details |
patients with neuromuscular complications limiting cardiac rehabilitation, acute coronary events, uncontrolled arrhythmias, patients on long term oxygen therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Circulatory metabolites |
At baseline
3 months follow up
6 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 6Minute Walk Test, Short Physical Performance Battery, clinical frailty score, cardiac self-efficacy, quality of life, cardiac depression scale, muscle strength, cardiac function |
at baseline, 3 months follow up and 6 months follow up |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pulmonary arterial hypertension (PAH) is a chronic disease with severe morbidity and mortality. The role of exosomes (EXO) contributing to PAH is now being explored with two studies showing benefits. Exercise is a promising intervention that produces functional and clinical benefits in PAH. Nevertheless, the role of EXO and exercise in PAH has yet to be explored. This study thus aims to study the effects of exercise on changes in the EXO in an animal model of PAH and human participants with PAH
|