| CTRI Number |
CTRI/2025/04/084194 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| 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
|
Comparing the Effects of Low and Moderate Intensity Exercise on Heart Health in People with High Blood Pressure |
|
Scientific Title of Study
|
Effect of low versus moderate intensity resistance exercise training on cardiac
autonomic responses in hypertensive individuals: A randomized controlled
trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adila Parveen |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Milllia Islamia |
| Address |
Room no 111, first floor, Centre for Physiotherapy and Rehabilitation
Sciences, Jamia Millia Islamia, New Delhi.
South
DELHI
110025
India |
| Phone |
8587868142 |
| Fax |
|
| Email |
aparveen1@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Aziza Nazneen |
| Designation |
MPT Cardio |
| Affiliation |
Jamia Milllia Islamia |
| Address |
c/o Centre for Physiotherapy and Rehabilitation
Sciences, Jamia Millia Islamia, New Delhi.
South
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
aziza4jjmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adila Parveen |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Milllia Islamia |
| Address |
Room no 111, first floor, Centre for Physiotherapy and Rehabilitation
Sciences, Jamia Millia Islamia, New Delhi.
DELHI
110025
India |
| Phone |
8587868142 |
| Fax |
|
| Email |
aparveen1@jmi.ac.in |
|
|
Source of Monetary or Material Support
|
| Centre for physiotherapy and rehabilitation sciences, Jamia Millia Islamia, New Delhi-110025 |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Centre for physiotherapy and rehabilitation sciences, Jamia Millia Islamia, New Delhi-110025 |
| Type of Sponsor |
Other [Jamia Millia Islamia,New Delhi-110025] |
|
|
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 Adila Parveen |
Centre for physiotherapy and rehabilitation sciences, |
CPRS clinic, ground floor,
Jamia Millia Islamia
Jamia Nagar
South
DELHI |
8587868142
adilaprvn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
No Intervention |
| Intervention |
Low-intensity resistance training group |
3 times/week for 6 weeks, on non
consecutive days |
| Intervention |
Moderate-intensity resistance training group |
3 times/week for 6 weeks, on non
consecutive days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
inclusion criteria
Pre diagnosed stage 2 hypertension |
|
| ExclusionCriteria |
| Details |
patient having bp of more than 160/100 mmmg
having unctrolled hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate variability (HRV)
Heart rate recovery (HRR)
Systolic Blood pressure recovery
Anxiety level
Sleep quality |
Pre data
Post data after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Systolic Blood pressure recovery
Anxiety level
Sleep quality |
Pre data and
Post data after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
14/04/2025 |
| 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="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Subjects will be
explained the purpose and methodology and possible risks of the study, they will be given
informed consent form explaining their rights as research subjects. All identifying information
on the consent form and demographic/injury history questionnaire will be kept confidential by
assigning number to each subject.
They will be selected based on inclusion criteria and exclusion criteria and will be divided into groups. Subjects were explained to refrain from any caffeine products and strenuous physical activity on testing days. All the tests will be conducted in laboratory setting at Centre
for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia following standard
prescription as per physician. Their demographic data, medical history and baseline data were
assessed a day before exercise session begins. Height, weight and blood pressure of the subjects
will be measured by stadiometer, weighing machine, sphygmomanometer respectively. Subjects
will not be allowed to eat or drink coffee for 2 h before the exercise. Pre-training measurements
will be done a day before the start of training and Post-training measurements after 6 weeks will
be done a day after completion of training. |