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CTRI Number  CTRI/2017/03/008280 [Registered on: 31/03/2017] Trial Registered Retrospectively
Last Modified On: 15/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of different types of exercise training on resting blood pressure 
Scientific Title of Study   Comparison of different types of exercise training on resting blood pressure in 30-45 years old hypertensive patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1191-4553  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sivachidambaram Kulandaivelan 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology 
Address  Dept. of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  9996003995  
Fax    
Email  tryhard2024@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Sivachidambaram Kulandaivelan 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology 
Address  Dept. of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  9996003995  
Fax    
Email  tryhard2024@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Sivachidambaram Kulandaivelan 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology 
Address  Dept. of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  9996003995  
Fax    
Email  tryhard2024@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr Sonu Punia, MPT, (PhD), Assistant Professor, Dept. of Physiotherapy, Guru Jambheshwar University of Science and Technology Hisar- 125001. 
 
Primary Sponsor  
Name  Guru Jambheshwar University of Science and Technology 
Address  New Delhi - Sirsa Highway, Hisar-125001. Haryana. India. 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonu Punia MPT PhD  Guru Jambheshwar University of Science and Technology  Room No: 3, Ground Floor, Dept. of Physiotherapy, Health Center, Guru Jambheshwar University of Science and Technology
Hisar
HARYANA 
9466373990

sonu.punianeuropt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension, Pre-hypertension (SBP 130-139 mmHg and DBP 85-89 mmHg) and Stage I Hypertension (SBP 140-159 mmHg and DBP 90-99 mmHg),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aerobic exercise [A]  Exercise (walk or jog) will be given at the intensity of 60-75% target heart zone. Polar heart rate monitor will be used. Session duration 30-45 minutes. Frequency 3 sessions per week. Total duration 8 weeks. 
Comparator Agent  Control or waiting list group  They will not be given any exercise and continue their normal physical activity 
Intervention  Isometric exercise [I]  Unilateral isometric hand-grip exercise will be given in sitting position at 30% of maximal isometric contraction. 4 isometric exercise for 2 minutes with 4 minutes rest in-between. Both hand will be covered. Frequency 3 sessions per week. Total duration 8 weeks.  
Intervention  Progressive resisted exercise [PRE]   This group will be give 8 body-weight resistance exercise as circuit training. Total 3 sets with 5 minutes rest in-between. Frequency 3 sessions per week. Total duration 8 weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Both pre and stage I hypertension
2. Both sedentary as well as recreationally active person
3. Both medicated as well as non-medicated patients 
 
ExclusionCriteria 
Details  1. Normal blood pressure
2. Stage II or more hypertension (SBP 160 mmHg or more and DBP 100 mmHg or more)
3. Respiratory problem
4. Arthritis and other lower limb musculoskeletal disorders
5. Diabetes
6. Metabolic Syndrome
7. Neuro-muscular diseases
8. Very active like current sports participation 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Resting blood pressure
 
End of 4th, 6th, 8th, 10th, 12th, 14th weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean arterial pressure
Pulse pressure 
End of 4th, 6th, 8th, 10th, 12th, 14th weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   30/01/2017 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Punia S, Kulandaivelan S, Punia V. 2016. Effect of aerobic training and resistance training on blood pressure in Indian: Systematic review. Indian Journal of Science and Research, 5(4):1373-76. Sonu Punia, Sivachidambaram Kulandaivelan, Varun Singh, Vandana Punia. 2016. Effect of aerobic training on blood pressure in Indians: Systematic review. International Journal of Chronic Diseases, Article ID: 1370148. Sonu Punia, Sivachidambaram Kulandaivelan, Vandana Punia. 2016. Effect of resistance exercise training on blood pressure in Indians: Systematic review. Saudi Journal of Sports Medicine, 16(3):174-78. Sonu Punia, Kulandaivelan S, Vandana Punia. 2016. Effect of Isometric strength training on blood pressure: Systematic review of literature with specific emphasis on Indians. Journal of Exercise Science and Physiotherapy, (accepted). 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Hypertension is the modifiable risk factor that leads to many cardiovascular diseases. It is rising at alarming rate in urban India. Exercises in the form of aerobics, progressive resistance exercise and isometrics has shown to reduce blood pressure in early stage hypertension. In fact, these are the first line management (life-style modification) in these populations. Recently, isometric exercise in the form of hand-grip exercise has shown superior to that of other form of exercises. However, no study till date compared all these 3 types of interventions. Thus primary objective of this trial is to compare these three interventions in early stage hypertensive urban Indian population. Sample size of this trial will be 120 [60 prehypertension and 60 stage I hypertension; 60 males and 60 females] from 405 eligible patients of a urban cohort. After getting their informed consent, they will be divided into 4 groups (Control or waiting list [C]; aerobic exercise [A]; progressive resisted exercise [PRE] and isometric exercise [IHG]) with 30 patients per group. Aerobic exercise group will be given exercise (walk or jog) at 60-75% target heart rate for 30 minutes. Progressive resisted exercise group will be given 8 body-weight exercises in the form of circuit training (3 cycles with 5 minutes rest in-between). Isometric exercise will be given four 2 minutes bouts of hand-grip exercise at 30% of maximal isometric contraction with 4 minutes rest in-between. Frequency of exercise will be three sessions per week for the total duration of 8 weeks. Outcome variable will be measured at pre, during (4th, 6th ), immediately after (8th ) as well as 10th, 12th and 14th weeks of post-exercise training.  

 
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