NCT06845436

Brief Summary

Background: Hypertension has long been considered as a major risk factor for cardiovascular disease representing a high public health concern. Objectives: the purpose of this study is to evaluate the effects of combined HIIT and resistance training on body composition, blood pressure, and cardiorespiratory fitness in obese hypertensive men. Methods: This study will make use of sixty obese hypertensive men aged 40 to 60 years. All participants meeting the eligibility criteria will be assigned to one of three groups; combined HIIT and resistance group, HIIT only group or control group. Combined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax. The resistance training session will be composed of eight exercises perform 3 sets of 8-12 repetitions with an intensity of 80% of the subject's estimated 1-RM. The HIIT only group perform 12 weeks of HIIT only. The control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period. Body composition measures, blood pressure and VO2peak will be assessed at baseline and at the end of the study period. Results: All the outcome variables will be assessed at baseline and 12 weeks following the treatment period.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

February 20, 2025

Last Update Submit

June 1, 2025

Conditions

Keywords

hypertension.obesityHigh Intensity Interval Trainingresistance trainingblood pressure

Outcome Measures

Primary Outcomes (4)

  • blood pressure in mmhg

    12 weeks

  • peak oxygen consumption in ml/kg/min

    12 weeks

  • body weight in Kg

    12 weeks

  • body mass index in kg/m2

    12 weeks

Study Arms (2)

study group

EXPERIMENTAL

Combined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax. The resistance training session will be composed of eight exercises perform 3 sets of 8-12 repetitions with an intensity of 80% of the subject's estimated 1-RM. The HIIT only group perform 12 weeks of HIIT only.

Behavioral: Exercise

control group

OTHER

The control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period.

Other: routine physical activity

Interventions

ExerciseBEHAVIORAL

Combined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax.

study group

The control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period.

control group

Eligibility Criteria

Age40 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • men aged between 40 and 60 years old,
  • have been diagnosed with clinical stage 1 or 2 hypertension,
  • being obese with body mass index more than 30 kg/m2
  • physically inactive

You may not qualify if:

  • musculoskeletal problems that may limit their ability to participate in resistance or HIIT programs
  • diabetes mellitus
  • a history of respiratory or chronic heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sattam bin Abdulaziz University

Riyadh, Alkharj, 16278, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

HypertensionObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ahmed S Ahmed, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

April 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

June 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations