Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults

October 21, 2022 updated by: Riphah International University

Compare the Effects of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults

To compare the effects of aerobic, resistance and combined training in hypertensive obese patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
63

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
    • Azad Jamu Kashmir
      • Kotli, Azad Jamu Kashmir, Pakistan, 11100
        • District Headquarter Hospital - kotli

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

36 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypertensive with BP greater than 140/90 mmHg
  • Overweight and obese adults with BMI (25-40)
  • Physically inactive from past 6 months assessed with pedometer. Those with step count of less than 7000 will be included
  • To be able to exercise (6MWT),t hose who completed the test without any symptom

Exclusion Criteria:

  • Any active systemic illness that restricts exercise
  • People doing exercise on regular basis
  • Any cardiopulmonary , metabolic and neurological illness

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: Supportive Care
  • 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.
Experimental: Aerobic exercise training Group
Other: Aerobic exercise training Group
Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 30 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 30 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 30 minutes
Experimental: Resistance Exercise Training Group
Other: Resistance Exercise Training Group

Resistive Exercises includes (a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction.

At Week 1-2, 10 repetitions 1 set, 3 days/week, for 30 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 30 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 30 minutes
Experimental: Combined Exercise Training Group
Other: Combined Exercise Training Group

Combined Exercise training includes [Aerobic: Treadmill walking + Resistive Training: a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction] Time will be reduced to 15 minutes for both trainings in respective weeks. Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 15 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 15 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 15 minutes

Resistive Exercises At Week 1-2, 10 repetitions 1 set, 3 days/week, for 15 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 15 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 15 minutes

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
Systolic and diastolic blood pressure
Time Frame: 6 weeks
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
6 weeks
Body Mass Index (BMI)
Time Frame: 6 Week
Changes from the Baseline, Body mass index (BMI) will be calculated as weight (kg)/height (m2). Below 18.5 Underweight 18.5 - 24.9 Healthy Weight 25.0 - 29.9 Overweight 30.0 and Above Obesity
6 Week
Change in blood lipid profile
Time Frame: 6 Week
Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.
6 Week
Step Count
Time Frame: 6 week
Pedometer is a valid self-report measure of physical activity. Pedometer is used to count the average daily steps. Change from the baseline to 6 week will be compared.
6 week
Waist circumference
Time Frame: 6 week
Waist circumference will be measured for abdominal or central fat mass. It is measured in cm at the middle distance between the last floating rib and the iliac crest using a retractable ergonomic measuring tape. Change from the baseline to 6 week will be compared.
6 week

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.
Riphah International University

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.
September 10, 2021

Primary Completion (Actual)

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.
August 30, 2022

Study Completion (Actual)

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.
August 30, 2022

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 18, 2021

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 28, 2021

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 29, 2021

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.
October 24, 2022

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.
October 21, 2022

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.
October 1, 2022

More Information

Terms related to this study

Keywords

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.
  • REC/01083 Sidra Asghar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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