| CTRI Number |
CTRI/2021/10/037127 [Registered on: 06/10/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Impact of acute and chronic regular exercise on arterial stiffness and reflection measures in coronary artery disease patients |
|
Scientific Title of Study
|
Impact of acute and chronic regular exercise on arterial stiffness and reflection measures in coronary artery disease patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav Kapoor |
| Designation |
PhD Scholar |
| Affiliation |
Jayoti Vidyapeeth Women’s University |
| Address |
Jayoti Vidyapeeth Women’s University
Vedaant Gyan Valley,
Village-Jharna, Mahala Jobner Link Road, NH-8
Jaipur Ajmer Express Way,
Jaipur
Jaipur
RAJASTHAN
303122
India |
| Phone |
9872400711 |
| Fax |
|
| Email |
gauravkapoor00711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anchit Gugnani |
| Designation |
Associate Proffessor |
| Affiliation |
Jayoti Vidyapeeth Women’s University |
| Address |
Vedaant Gyan Valley Village-Jharna, Mahala Jobner Link Road NH-8 Jaipur Ajmer Express Way, Jaipur-303122, Rajasthan (INDIA)
India
Jaipur
RAJASTHAN
303122
India |
| Phone |
9351455030 |
| Fax |
|
| Email |
anchitgugnani19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy, Faculty of Medicine University Punjabi University, Patiala, Punjab
Patiala
PUNJAB
147002
India |
| Phone |
9417802490 |
| Fax |
|
| Email |
sandyraina24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indus Super Speciality Hospital |
|
|
Primary Sponsor
|
| Name |
Jayoti Vidyapeeth Womens University |
| Address |
Jayoti Vidyapeeth Women’s University
Vedaant Gyan Valley,
Village-Jharna, Mahala Jobner Link Road, NH-8
Jaipur Ajmer Express Way,
Jaipur-303122 |
| Type of Sponsor |
Other [self sponsored study] |
|
|
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 Anjali Gupta |
Indus Super specialty Hospital |
Department of Physiotherapy, Cardiac division, Phase-I, sector-55, Mohali, Punjab(India)
Rupnagar
PUNJAB |
9896730704
amugupta2021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Jayoti Vidyapeeth womens university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I700||Atherosclerosis of aorta, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Aerobic exercises, 2. Resistance,3. Combined aerobic and resistance exercise, 4. No exercise |
1. 30-mins cycling at 60-90 % Heart rate maximum, 2. 30-mins Resistance training at 50-80% 10RM, 3. 15 minutes Resistance training and 15-minutes Aerobic exercises, 4. Activity of daily living
In all the four groups: Warm up and cool down exercises including relaxation exercises like breathing exercises, light stretching and rhythmic movement of all the four limbs
|
| Comparator Agent |
1.Aerobic exercises, 2. Resistance,3. Combined aerobic and resistance exercise, 4. No exercise |
1. cycling 2. Resistance training at 50-80% 10RM using weights and/or theraband, 3. combination of Resistance training and Aerobic exercises, 4. Activity of daily living |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
the presence of CAD, which is defined as the patient having at least one of the following: angiographically documented stenosis ≥50% in at least one major coronary artery; prior history of myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CAGB) surgery; positive exercise stress test determined by a positive nuclear scan, or symptoms of chest discomfort accompanied by electrocardiographic (ECG) changes of > 1mm horizontal or down sloping ST segment depression. |
|
| ExclusionCriteria |
| Details |
non-cardiac surgical procedure within two months, MI or CABG within two months, PCI within one month, NYHA class II-IV symptoms of heart failure, documented valve stenosis, documented severe chronic obstructive pulmonary disease, symptomatic peripheral arterial disease, unstable angina, uncontrolled hypertension, uncontrolled atrial arrhythmia or ventricular dysrhythmia, insulin requiring diabetes mellitus, and any musculoskeletal abnormality that would limit exercise participation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this research is to identify whether long term exercise can beneficially modify hemodynamic profile especially pulse wave velocity and augmentation index in subjects with Coronary artery disease |
4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will further investigate the mechanisms for changes in hemodynamic profile benefits to improve CVD risk for patients with CAD |
4 weeks and 8 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
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cardiovascular disease (CVD) is predicted as the
leading cause of death worldwide until 2030 with measures for early detection
and progress monitoring essential to manage the condition and its associated
health costs. In the developed world, much progress has already
been made in the fight against heart disease. However, death rate
due to cardiovascular diseases continuously increasing in the developing part
of the world since last 50 years. In
India, many studies had reported soar in the cardiovascular disease in
comparison to last 60 years from 1% to 9-10% in urban areas and <1% to 4%-6%
in rural locations. Further, coronary heart disease is still the
leading cause-of-death for both men and women in India. In contrast to 1990,
mortality among men and women has raised by 31% and 13% in 2015. For men and women, coronary heart disease is listed at number one, followed by
pulmonary disorders and cancer respectively. Vascular stiffness due
to arteriosclerosis may reduce arterial elasticity which is as an independent, non-
invasive predictor of future incidence of coronary heart disease, stroke, and
mortality. Further, greater vascular stiffness has been considered as
one of the leading signs of vascular damage leading to CVD. This current project will
determine the acute and chronic effects of 8-weeks of aerobic, resistance and
combined exercise on arterial hemodynamic function (i.e. PWV, AIx) in those
with coronary artery disease. AIMS
1.
To
examine the impact of acute aerobic exercise on arterial stiffness measures in
patients with CAD;
2.
To
examine the impact of chronic exercise training on resting and post-exercise arterial
stiffness measures in patients with CAD;
3.
To
identify the mechanisms (e.g. blood pressure, heart rate, NO availability,
endothelial function) by which acute/chronic aerobic exercise alters arterial
stiffness in patients with CAD;
EXPECTED RESEARCH CONTRIBUTION Our research will help to identify whether long term exercise can
beneficially modify hemodynamic profile especially PVW and AIx in subjects with
CAD. In addition, it will investigate the mechanisms for such benefits to
improve CVD risk for patients with CAD. This study will be a prospective,
single-blind, randomised controlled study examining the effects of exercise on
arterial stiffness. Patients with CAD (n=60-80; 15-20 per group) will be
randomised to one of four treatment groups (aerobic exercise, resistance exercise,
combined aerobic and resistance exercise, and no exercise). The three exercise groups will undertake 8
weeks of supervised training, three times a week in accordance with recommended
guidelines (ACSM). The non-exercise groups will undertake no exercise training.
|