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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Procedure: 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.
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.
Procedure: 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: Isometric Wall Squat
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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