NCT06610006

Brief 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. 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 20, 2024

Last Update Submit

September 20, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Rate Pressure Product

    Measured by multiplying Heart Rate and Systolic Blood Pressure

    5 weeks

  • Blood Pressure(SBP and DBP)

    Evaluation will be done using sphygmomanometer

    5 weeks

  • Heart rate

    Heart Rate will be measured using pulse oximeter.

    5 weeks

  • Anthropometric Measures Waist circumference

    Measuring Tape will be used to measure Waist circumference

    5 weeks

  • Anthropometric Measures hip circumference

    Measuring Tape will be used to measure hip circumference

    5 weeks

  • Anthropometric Measures Waist to hip ratio

    Ratio of waist circumference and hip circumference

    5 weeks

  • BMI

    Body mass index ratio of weight and height

    5 weeks

Study Arms (2)

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

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.

Procedure: High Intensity Interval Training (HIIT)Procedure: Isometric Wall Squat

Interventions

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.

High Intensity Interval TrainingHigh Intensity Interval Training (HIIT) and 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

High Intensity Interval Training (HIIT) and Isometric Wall Squat

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Prehypertension

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

June 10, 2024

Primary Completion

December 10, 2024

Study Completion

December 15, 2024

Last Updated

September 24, 2024

Record last verified: 2024-09

Locations