| 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
|
|
|
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
|
|
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. |