| CTRI Number |
CTRI/2025/05/086853 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of two types of exercise on blood pressure and effort level in people with high blood pressure. |
|
Scientific Title of Study
|
Comparative study of effect of concentric and eccentric resisted exercises on blood pressure and rate of perceived exertion in individuals with hypertension: a parallel group randomized clinical 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 |
Tasneem Sabir Rizvi |
| Designation |
Postgraduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institue for Orthopaedics and Rehabilitation College of Physiotherapy
11/12, Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8806575152 |
| Fax |
|
| Email |
tasneemrizvi14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajakta Sahasrabudhe |
| Designation |
Professor and HOD |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy
11/12, Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9930677920 |
| Fax |
|
| Email |
prajakta.sahasrabudhe2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta Sahasrabudhe |
| Designation |
Professor and HOD |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy
11/12, Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9930677920 |
| Fax |
|
| Email |
prajakta.sahasrabudhe2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune 411005 Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation Collee of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivaji Nagar, Pune 411005 |
| Type of Sponsor |
Private 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 Tasneem Rizvi |
Sancheti Institue for Orthopaedics and Rehabilitation College of Physiotherapy |
Department of Cardiovascular and Respiratory Physiotherapy, Sancheti Institue for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivaji Nagar, Pune 411005
Pune
MAHARASHTRA |
8806575152
tasneemrizvi14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institue Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with Hypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic and concentric resisted exercise |
The subjected will be instructed to perform aerobic exercise (walking) for 30 mins followed by concentric resisted exercise with 2-3 seconds of sustained contractions for 75 % of 1 RM, 3 sets of 8 to 12 repetitions with 1 min rest between each set. The exercises will include bicep curls, shoulder press, lateral raises, seated leg extension, straight leg raises and side lying hip abduction. Sessions will be taken for 4 weeks-3 days/week. |
| Comparator Agent |
Aerobic and eccentric resisted exercise |
The subjected will be instructed to perform aerobic exercise (walking) for 30 mins followed by concentric resisted exercise with 4-6 seconds of sustained contractions for 75 % of 1 RM, 3 sets of 8 to 12 repetitions with 1 min rest between each set. The exercises will include bicep curls, shoulder press, lateral raises, seated leg extension, straight leg raises and side lying hip abduction. Sessions will be taken for 4 weeks-3 days/week. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with stage one Hypertension (American College of Cardiology (ACC) and American Heart Association (AHA) 2017 guidelines)
Systolic BP: 130 to 139 mmHg
Diastolic BP: 80 to 89 mmHg
2. No participation in structured aerobic or resisted exercise program for past 6 months
3. Patients on anti-hypertensive medications |
|
| ExclusionCriteria |
| Details |
1. Hypertensive patients who experience disorders in the upper or
lower extremities
2. Patients with diagnosis of CVD or neuromuscular disorder
3. Patients with secondary hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure |
At baseline (0 weeks) and after intervention (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of perceived exertion |
At baseline (0 weeks) and after intervention (4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/05/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 a major global health issue, and exercise is a key non-pharmacological approach for managing it. While resistance training has shown benefits for blood pressure control, there is limited comparative data on concentric vs. eccentric resistance training in hypertensive individuals. Eccentric training may cause less cardiovascular strain, potentially making it safer, but issues like muscle soreness and recovery need further exploration. Additionally, Rate of Perceived Exertion (RPE) plays a vital role in exercise adherence and safety. Comparing the effects of concentric and eccentric resistance training on blood pressure and RPE in hypertensive individuals can guide safer and more effective exercise prescriptions.
Null Hypothesis: - (H0): - There will be comparable effects of concentric and eccentric resisted exercises on blood pressure in individuals with Hypertension. (H0): - There will be comparable effects of concentric and eccentric resisted exercises on rate of perceived exertion in individuals with Hypertension. Alternate Hypothesis: - (H1) - Concentric resisted exercises reduce blood pressure more effectively than eccentric resisted exercise in individuals with hypertension. (H2) - Concentric resisted exercises reduce rate of perceived more effectively than eccentric resisted exercise in individuals with hypertension. (H3) - Eccentric resisted exercises reduce blood pressure more effectively than concentric resisted exercise in individuals with hypertension. (H4) - Eccentric resisted exercises reduce rate of perceived exertion more effectively than concentric resisted exercise in individuals with hypertension.
|