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CTRI Number  CTRI/2023/05/053191 [Registered on: 29/05/2023] Trial Registered Prospectively
Last Modified On: 18/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   comparison of stretching exercise of arms and legs in stage-I hypertension. 
Scientific Title of Study   Comparison of the effect of upper limb and lower limb passive static stretching exercise on acute cardiovascular response in patients with stage-I hypertension. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akanksha 
Designation  PG Student 
Affiliation  College of physiotherapy, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak 
Address  College of Physiotherapy, room number 4, E-block, Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College of Physiotherapy, room number 4, E-block, Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  9518498892  
Fax    
Email  akankksha4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gitanjali Sikka 
Designation  Assistant Professor 
Affiliation  Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak  
Address  College of Physiotherapy, room number 4, E-block, Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College of Physiotherapy, room number 4, E-block, Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  7027192620  
Fax    
Email  gsikka.cphy@uhsr.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Gitanjali Sikka 
Designation  Assistant Professor 
Affiliation  Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak  
Address  College of Physiotherapy, room number 4, E-block, Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College of Physiotherapy, room number 4, E-block, Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  7027192620  
Fax    
Email  gsikka.cphy@uhsr.ac.in  
 
Source of Monetary or Material Support  
Akanksha 
 
Primary Sponsor  
Name  Akanksha 
Address  College of Physiotherapy, room number 4, E-block, Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak  
Type of Sponsor  Government medical college 
 
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 Deepak Jain  Medicine Department, PGIMS, Rohtak  College of Physiotherapy, room number 4, E-block, Pt B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA 		 9416147887

deepakjain@uhsr.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt. B. D. Sharma post graduate institute of medical sciences, UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lower limb passive static stretching exercise  Lower limb passive static stretching exercise: 3sets - stretched 3 times, sustained for 20 sec and 10 sec rest in between. 
Intervention  Lower limb passive static stretching exercise  Lower limb passive static stretching exercise: 6sets - stretched 6 times, sustained for 20 sec and 10 sec rest in between. 
Comparator Agent  Not applicable  Not applicable 
Intervention  Upper limb passive static stretching exercise  Upper limb passive static stretching exercise: 3sets - stretched 3 times, sustained for 20 sec and 10 sec rest in between. 
Intervention  Upper limb passive static stretching exercise  Upper limb passive static stretching exercise: 6sets - stretched 6 times, sustained for 20 sec and 10 sec rest in between. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adults with age group of 18-60yrs.
2. Clinically diagnosed with Stage -1 Hypertension.
3. Blood pressure under control with anti-hypertensive medications. 
 
ExclusionCriteria 
Details  1. History of unstable cardiovascular condition/ cardiac diseases.
2. Patients clinically diagnosed with Diabetes mellitus, renal diseases.
3. Patients diagnosed with any orthopaedic conditions.
4. Patient diagnosed by physician with mental illness, psychiatric disorder, cognitive
impairment.
5. Patient who is not willing for participation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Systolic blood pressure
Diastolic blood pressure
Mean arterial blood pressure
Rate pressure product
Heart rate
Oxygen Saturation 		 Before, immediately, After 5min, after 15 min, after 30 min and after 1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   05/06/2023 
Date of Study Completion (India) 15/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is an experimental study design.
Aim of the study is to compare the effectiveness of Upper limb and Lower limb stretching exercise and acute cardiovascular responses in Stage-I Hypertensive patients. All the individuals will participate in all of the protocols. The participants will be randomly allocated in 4 exercise groups (Group 1, Group 2, Group 3, Group 4) with the gap of 48h (washout interval) within each group, using computer generated randomized list. All the participants will participate in all of the exercise groups. Individuals underwent baseline “PRE” measurements of systolic blood pressure, diastolic blood pressure, HR, and SPO2, will be obtained before each exercise group of stretching exercise programme. Measurement will be repeated immediately after the intervention”POST1”, 5 min “POST-2” , 10 min “POST-3”, 15 min “POST-4” and 1 hour “POST-5” in the sitting position after the stretching exercise programme in order to determine the effects of passive static stretching exercises. All the exercise will be done with the education of valsalva maneuvar, participants were educated about not to hold breath during exercises to avoid the effect of valsalva maneuvar. In experimental session muscles of upper limb and lower limb which includes pectoralis, trapezius, triceps, biceps brachii, quadriceps, hamstrings, gastrocnemius, glutei will be stretched for 20 sec and 10 sec rest in between. The divided experimental protocols will be named as control group, group1, group2, group3 and group4. Group1 and 2 will be of upper limb muscles passive static stretching exercise with different number of sets and group 3 and 4 will be of lower limb muscles passive static stretching exercise with different number of sets. 
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