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

Primary Purpose

Obese, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic exercise training Group
Resistance Exercise Training Group
Combined Exercise Training Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obese focused on measuring Aerobic Exercise, Resistive exercise, Combined Aerobic and Resistive Exercise

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • District Headquarter Hospital - kotli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Aerobic exercise training Group

Resistance Exercise Training Group

Combined Exercise Training Group

Arm Description

Outcomes

Primary Outcome Measures

Systolic and diastolic blood pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Body Mass Index (BMI)
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
Change in blood lipid profile
Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.
Step Count
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.
Waist circumference
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2021
Last Updated
October 21, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05061173
Brief Title
Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
Official Title
Compare the Effects of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Hypertension
Keywords
Aerobic Exercise, Resistive exercise, Combined Aerobic and Resistive Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise training Group
Arm Type
Experimental
Arm Title
Resistance Exercise Training Group
Arm Type
Experimental
Arm Title
Combined Exercise Training Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Aerobic exercise training Group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Resistance Exercise Training Group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Combined Exercise Training Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Systolic and diastolic blood pressure
Description
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Time Frame
6 weeks
Title
Body Mass Index (BMI)
Description
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
Time Frame
6 Week
Title
Change in blood lipid profile
Description
Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.
Time Frame
6 Week
Title
Step Count
Description
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.
Time Frame
6 week
Title
Waist circumference
Description
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.
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Headquarter Hospital - kotli
City
Kotli
State/Province
Azad Jamu Kashmir
ZIP/Postal Code
11100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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