NCT05061173

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

September 10, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

September 18, 2021

Last Update Submit

October 21, 2022

Conditions

Keywords

Aerobic ExerciseResistive exerciseCombined Aerobic and Resistive Exercise

Outcome Measures

Primary Outcomes (5)

  • Systolic and diastolic blood pressure

    Changes from the Baseline, Blood pressure is measured through sphygmomanometer

    6 weeks

  • 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

    6 Week

  • Change in blood lipid profile

    Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.

    6 Week

  • 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.

    6 week

  • 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.

    6 week

Study Arms (3)

Aerobic exercise training Group

EXPERIMENTAL
Other: Aerobic exercise training Group

Resistance Exercise Training Group

EXPERIMENTAL
Other: Resistance Exercise Training Group

Combined Exercise Training Group

EXPERIMENTAL
Other: Combined Exercise Training Group

Interventions

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

Aerobic 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

Resistance 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

Combined Exercise Training Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Headquarter Hospital - kotli

Kotli, Azad Jamu Kashmir, 11100, Pakistan

Location

MeSH Terms

Conditions

ObesityHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Muhammad Iqbal Tariq, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2021

First Posted

September 29, 2021

Study Start

September 10, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations