Pre HypertensionNCT06610006
Combined Effects of Isometric Wall Squats and High Intensity Interval Training on Rate Pressure Product in Normotensive and Pre-hypertensive Sedentary Adults
A study testing High Intensity Interval Training (HIIT) and Isometric Wall Squat in people with Pre Hypertension, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pre Hypertension
- What is being tested?
- High Intensity Interval Training (HIIT) and Isometric Wall Squat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
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
Read the 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.
- Conditions
- Pre Hypertension
- Being tested
- High Intensity Interval Training (HIIT), Isometric Wall Squat
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (HIIT)Procedure or surgery
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.
Isometric Wall SquatProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Active comparator | 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 Receives: Procedure: High Intensity Interval Training (HIIT) |
| High Intensity Interval Training (HIIT) and Isometric Wall Squat | Experimental | 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. Receives: Procedure: High Intensity Interval Training (HIIT); Procedure: Isometric Wall Squat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate Pressure Product
Measured by multiplying Heart Rate and Systolic Blood Pressure
Measured: 5 weeks
Blood Pressure(SBP and DBP)
Evaluation will be done using sphygmomanometer
Measured: 5 weeks
Heart rate
Heart Rate will be measured using pulse oximeter.
Measured: 5 weeks
Anthropometric Measures Waist circumference
Measuring Tape will be used to measure Waist circumference
Measured: 5 weeks
Anthropometric Measures hip circumference
Measuring Tape will be used to measure hip circumference
Measured: 5 weeks
Anthropometric Measures Waist to hip ratio
Ratio of waist circumference and hip circumference
Measured: 5 weeks
BMI
Body mass index ratio of weight and height
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start10 Jun 2024
- Primary completion10 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre HypertensionStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial having two groups. One group(interventional group) will be doing High Intensity Training (HIIT) and Isometric Wall Squat and the other group (control group) will be doing High intensity Interval Training (HIIT).
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610006
- Sponsor's protocol ID
- FUI/CTR/2024/34
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Isometric Wall Squats and High Intensity Interval Training on Rate Pressure Product in Normotensive and Pre-hypertensive Sedentary Adults
- ClinicalTrials.gov ID
- NCT06610006
- Acronym / sponsor ID
- FUI/CTR/2024/34
- Conditions
- Pre Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group(interventional group) will be doing High Intensity Training (HIIT) and Isometric Wall Squat and the other group (control group) will be doing High intensity Interval Training (HIIT).
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Active comparator | Procedure: High Intensity Interval Training (HIIT)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 (HIIT) and Isometric Wall Squat | Experimental | Procedure: High Intensity Interval Training (HIIT), Procedure: Isometric Wall SquatHigh 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training (HIIT)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. | Procedure or surgery | High Intensity Interval Training, High Intensity Interval Training (HIIT) and Isometric Wall Squat |
| Isometric Wall SquatFor 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 | Procedure or surgery | High Intensity Interval Training (HIIT) and Isometric Wall Squat |
Primary outcome
Rate Pressure Product
Time frame: 5 weeks
Measured by multiplying Heart Rate and Systolic Blood Pressure
Blood Pressure(SBP and DBP)
Time frame: 5 weeks
Evaluation will be done using sphygmomanometer
Heart rate
Time frame: 5 weeks
Heart Rate will be measured using pulse oximeter.
Anthropometric Measures Waist circumference
Time frame: 5 weeks
Measuring Tape will be used to measure Waist circumference
Anthropometric Measures hip circumference
Time frame: 5 weeks
Measuring Tape will be used to measure hip circumference
Anthropometric Measures Waist to hip ratio
Time frame: 5 weeks
Ratio of waist circumference and hip circumference
BMI
Time frame: 5 weeks
Body mass index ratio of weight and height
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT) and Isometric Wall Squat in people with Pre Hypertension, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate Pressure Product (time frame: 5 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.