| CTRI Number |
CTRI/2024/08/072571 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Concurrent training versus Aerobic Excercise on Lipid Profile and Blood Pressure among Hypertensive patients |
|
Scientific Title of Study
|
Effects of Concurrent Training versus Aerobic Exercises on Lipid Profile
and Blood Pressure among Hypertensive Individuals |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Tah |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room B-31/6, Cardiopulmonary Physiotherapy Research Lab Maharishi Markandeshwar(Deemed to be University), Mullana-Ambala,
Haryana, India Pin 133207
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9734499769 |
| Fax |
|
| Email |
priyankatah16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep Kumar Jangra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
B-31/6, Cardiopulmonary Physiotherapy Research Lab Maharishi
Markandeshwar(Deemed to be University), Mullana-Ambala,
Haryana, India Pin 133207
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9416797708 |
| Fax |
|
| Email |
mandeep.jangra@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Tah |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
B-31/6, Cardiopulmonary Physiotherapy Research Lab Maharishi
Markandeshwar(Deemed to be University), Mullana-Ambala,
Haryana, India Pin 133207
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9734499769 |
| Fax |
|
| Email |
priyankatah16@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [Nil] |
|
|
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 Mandeep Kumar Jangra |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room No. B-31/6,
Cardiopulmonary
Research Lab,
Department of
Physiotherapy
Ambala
HARYANA
Ambala
HARYANA |
9416797708
mandeep.jangra@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic Exercise Group |
The training session consisted of a 5 min warm up,30 min aerobic exercise and 5 min cool down. The aerobic training group exercise on treadmill. Heart rate monitor was used to adjust workload to achieve target heart rate. The intensity will be started at 60% of MHR and progressive increase in intensity of 5% every week, and 4-week protocol. |
| Intervention |
Concurrent Training Group |
For Concurrent training group the training session consisted of a 5 min warm-up,15 min aerobic exercise,15 min resistance exercise and 5 min of cool-down exercise. The aerobic training group exercise on treadmill. Heart rate monitor was used to adjust workload to achieve target heart rate. The intensity will be started at 60% of MHR and progressive increase in intensity of 5% every week. Resistance training is referred to as strength training is a progressive use of varying loads, movements, and velocities to gain muscle mass
& strength. Exercise protocols with resistance band for the upper extremity are rowing, standing bench press, and arm curl, and for lower limb are knee extension, knee flexion, and forward walking with 75% of 1 RM intensity. Frequency is 2 sets of 10 reps each, 30-sec intervals, 5 days in a week, and 4-week protocol. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with hypertension.
Individuals who agree to participate. |
|
| ExclusionCriteria |
| Details |
Congestive heart failure or a recent myocardial infarction, Neurological and or orthopedic conditions contraindicating or limiting exercises
training, Peripheral arterial disease, Significant chronic artery pulmonary disease. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Systolic Blood Pressure
Diastolic Blood Pressure
Total Cholesterol
Triglycerides
HDL Cholesterol
LDL Cholesterol
VLDL Cholesterol |
Baseline & After intervention of 4 weeks (5 days per week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Hypertension is one of the most common medical disorders and is
associated with an increased incidence of mortality from cardiovascular disease, stroke, heart
failure, renal failure. The aim of the study is to compare the effectiveness of aerobic exercise and concurrent training (combination of aerobic exercise and resistance training) to manage the hypertension. Participants will be randomly assigned to either aerobic exercise training groups or concurrent training groups for 4 weeks. Outcome measures include lipid profiles and blood pressure. Concurrent training has effect on lipid profile and blood pressure
among hypertensive individuals. Patients will be recruited after getting CTRI registration no. |