- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06610006
Combined Effects of Isometric Wall Squats and High Intensity Interval Training on Rate Pressure Product in Normotensive and Pre-hypertensive Sedentary Adults
September 20, 2024 updated by: Foundation University Islamabad
Hypertension is leading yet preventable risk factor for cardiovascular disease and all-cause mortality worldwide.
Prehypertension identifies those at high risk of developing HTN, prompting intervention to prevent or delay the onset of the disease.
High intensity interval training (HIIT) is a time efficient mode of training with established benefits, while Isometric wall squats (IWS) also provide a range of proven benefits and advantages, but their combined effect on BP measures is yet to be determined.Hence the objective of this study is to compare the effects of isometric wall squats along with high intensity interval training versus high intensity interval training alone on rate pressure product, SBP and DBP, heart rate and anthropometric measures in normotensive and pre-hypertensive sedentary adults
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Pre-Hypertension is not a disease itself rather it categorizes those who are at the risk of developing hypertension in future.
By targeting pre-hypertensive and normotensive individuals we are focusing on preventive measures, potentially reducing incidence of HTN and cardiovascular conditions in future.
If found effective, this study can help in providing training protocols while also decreasing the risk of hypertension in future.A total of 15 sessions of high intensity interval training alone in one group and combination of high intensity interval and isometric wall squat in other group, for thrice a week on alternative days for 5 consecutive weeks will be given.
Study Type
Interventional
Enrollment (Estimated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Foundation University College of Physical Therapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both male and female adults aged 18-45 years.
- Participants lying in Low PA (inactive) category on basis of IPAQ.
- Pre-hypertensive adults:
- SBP- 120 mmHg or more and <140 mmHg
- DBP of 80 mmHg or more and < 90 mmHg.
- Normotensive adults: SBP < 120 mmHg and DBP < 80 mmHg. Exclusion Criteria
- Diagnosed with any current infections.
- Subjects with any diagnosed cardiovascular or respiratory conditions.
- Subjects with diagnosed musculoskeletal or neurological conditions which hinder participation in physical activity program.
- Active Smokers
- Those with any contraindication to exercise testing or training.
- Pregnant females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: High Intensity Interval Training
Participants will begin with warm-up exercises for 5-7 mins before the session.
Then they will begin high intensity interval training on treadmill with moderate intensity (40-60%HRR) in week 1 to achieve the baseline fitness level and from week 2 to 5 they will progress to high intensity with setting the lower target HR 40-60%HRR and upper target HR 80-85%HRR with 1:4 work to rest ratio followed by 5-7 min of cool-down period.A total of 15 sessions for thrice a week on alternative days for 5 consecutive weeks will be given
|
High intensity interval training on treadmill with moderate intensity (40-60%HRR) in week 1 to achieve the baseline fitness level and from week 2 to 5 they will progress to high intensity with setting the lower target HR 40-60%HRR and upper target HR 80-85%HRR with 1:4 work to rest ratio followed by 5-7 min of cool-down period..A total of 15 sessions of high intensity interval training alone , for thrice a week on alternative days for 5 consecutive weeks will be given.
Warm-up session consisting of stretching exercises prior to intervention and cool down session after intervention will also be done and vitals before and after the session will be taken.
|
|
Experimental: High Intensity Interval Training (HIIT) and Isometric Wall Squat
High intensity interval training on treadmill with moderate intensity (40-60%HRR) in week 1 to achieve the baseline fitness level and from week 2 to 5 they will progress to high intensity with setting the lower target HR 40-60%HRR and upper target HR 80-85%HRR with 1:4 work to rest ratio.
For isometric wall squat, each training session will be composed of 4 × 2-min bouts of IWS followed by 2-min rest periods At the end of each bout, participants will be given an RPE score.
This score will then be compared to a target RPE value and zone for each bout, There will be total 15 sessions thrice a week for 5 weeks.
|
High intensity interval training on treadmill with moderate intensity (40-60%HRR) in week 1 to achieve the baseline fitness level and from week 2 to 5 they will progress to high intensity with setting the lower target HR 40-60%HRR and upper target HR 80-85%HRR with 1:4 work to rest ratio followed by 5-7 min of cool-down period..A total of 15 sessions of high intensity interval training alone , for thrice a week on alternative days for 5 consecutive weeks will be given.
Warm-up session consisting of stretching exercises prior to intervention and cool down session after intervention will also be done and vitals before and after the session will be taken.
For isometric wall squat, each training session will be composed of 4 × 2-min bouts of IWS followed by 2-min rest periods.
In first week, participants will do squat training or there will be a protocol for selecting exercise intensity in which participants will be given 30-s to perform a wall squat to select a position that they predict would elicit an target RPE score by varying the squat height.
Based on the final squat height and RPE score, after bout 4, participants will be given a starting squat height for training session 1 and will then be progressed in each week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate Pressure Product
Time Frame: 5 weeks
|
Measured by multiplying Heart Rate and Systolic Blood Pressure
|
5 weeks
|
|
Blood Pressure(SBP and DBP)
Time Frame: 5 weeks
|
Evaluation will be done using sphygmomanometer
|
5 weeks
|
|
Heart rate
Time Frame: 5 weeks
|
Heart Rate will be measured using pulse oximeter.
|
5 weeks
|
|
Anthropometric Measures Waist circumference
Time Frame: 5 weeks
|
Measuring Tape will be used to measure Waist circumference
|
5 weeks
|
|
Anthropometric Measures hip circumference
Time Frame: 5 weeks
|
Measuring Tape will be used to measure hip circumference
|
5 weeks
|
|
Anthropometric Measures Waist to hip ratio
Time Frame: 5 weeks
|
Ratio of waist circumference and hip circumference
|
5 weeks
|
|
BMI
Time Frame: 5 weeks
|
Body mass index ratio of weight and height
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2024
Primary Completion (Estimated)
December 10, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
September 20, 2024
First Submitted That Met QC Criteria
September 20, 2024
First Posted (Actual)
September 24, 2024
Study Record Updates
Last Update Posted (Actual)
September 24, 2024
Last Update Submitted That Met QC Criteria
September 20, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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