Comparison Of Normal Walking Vs Brisk Walking In Over-Weight Adults

July 18, 2023 updated by: Riphah International University

Comparison of Normal Walking Vs Brisk Walking on Body Fat, Hypertension, Diabetes, and Level of Happiness in Over-Weight Adults.

The goal of this clinical trial is to see the comparison of normal walking vs brisk walking on body fat, hypertension, diabetes, and level of happiness in over-weight adults. The main question it aims to answer is:

Will there be a difference between the effectiveness of normal walking and brisk walking on improving body fat, hypertension, diabetes, and level of happiness in over-weight adults..

The participants will be divided into two groups; group A and group B. Group A will perform normal walk and Group B will perform brisk walk.

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.

Detailed Description

In the modern times, despite the fact that the benefits of regular physical activity are widely known, the choice of a sedentary lifestyle is increasing in prevalence. With the help of simple and natural movements, walking is considered as a moderate level of workout intensity that promotes a long and healthy lifespan. Meanwhile, it provides the added advantage to individuals by reducing chances of injury, making it an excellent choice for middle-aged and elderly individuals. Walking tends to be the widely preferred choice of most diabetic patients worldwide for improving glycemic control. Moghetti et al. showed the correlation between walking and type 2 diabetes in their recent research where they employed meta-analysis (supported with short and long term RCTs) to prove that sufficient amount of walking can lead to improved levels of HbA1c. Walking can improve functional capacity of people with T2DM and cast favorable impacts on chronic complications of diabetes The research carried out to advocate strong relation between walking and healthy lifestyle is widely available to us. However, it mainly focuses on elderly people (with age above 60) instead of young and middle-aged people who have been equally pushed at the verge of risks to develop obesity, cardiovascular diseases and T2D due to astonishingly common sedentary lifestyle prevailing in today's world. Also, it is limited in terms of defined intensities for walking and their comparison for guiding an appropriate course of action for obese or hypertensive adults. Therefore, this research will evaluate and compare the impacts of normal and brisk walking on middle-aged people struggling with diabetes, hypertension, obesity or other cardiovascular diseases. Also, it will define the basis for a well-informed and focussed approach to enhance quality of life in adults.

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.
20

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, O5499
        • Polymed

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 36-55 years
  • Hypertensive middle-aged adults
  • BMI > 25
  • Type 2 diabetes middle-adults
  • Body fat > 25%

Exclusion Criteria:

  • Severe psychological illness
  • Physical defect or deformity
  • Experience of diabetic coma
  • Engagement in other training programs
  • Any other serious illness like TB, cancer.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: Normal Walking Group
Adhering to FITT method, normal walking will be performed 5 days a week (frequency) to ensure optimal results. Speed (intensity) for normal will be 3.5 mph
Other: Normal Walking

Adhering to FITT method, normal walking will be performed 5 days a week (frequency) to ensure optimal results. Speed (intensity) for normal will be 3.5 mph. The pulse rate of participants will be monitored through treadmill monitor. The duration (time) of walk each day will be 30 minutes.

Measurement of body fat percentage, hypertension, diabetes, and level of happiness (at the beginning and ending of twelve weeks)
Experimental: Brisk Walking Group
Adhering to FITT method, brisk walking will be performed 5 days a week (frequency) to ensure optimal results. Speed (intensity) for normal will be 4.5 mph.
Other: Brisk Walking

Adhering to FITT method, brisk walking will be performed 5 days a week (frequency) to ensure optimal results. Speed (intensity) for normal will be 4.5 mph. The pulse rate of participants will be monitored through treadmill monitor. The duration (time) of walk each day will be 30 minutes.

Measurement of body fat percentage, hypertension, diabetes, and level of happiness (at the beginning and ending of twelve weeks)

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
Body Fat
Time Frame: 12 Weeks
Skin fold caliper will be used for measuring body fat having reliability index of 96%. Validations of these results are costly using dual-energy x-ray absorptiometry (DXA) or hydrostatic weighing. Therefore, pre-published articles shall be taken as basis for employment of skin fold calipers to measure body fat.
12 Weeks
Blood Pressure
Time Frame: 12 Weeks
A properly calibrated sphygmomanometer with initial mercury reading at 0 will be used for measuring blood pressure. The reliability of sphygmomanometer is measured at 83% with only 4% showing a difference of more than 10 mm Hg. Both manual and digital sphygmomanometer shall be used to validate the final result.
12 Weeks
Blood Glucose
Time Frame: 12 Weeks
Red blood cells live for up to 3 months, so HbA1c gives an indication of how much sugar there has been in the blood over the past few months. It's different to the blood glucose test, which measures how much sugar is in the blood at that moment. The sensitivity and specificity ranged from 24% to 78% and 79% to 100% respectively for HbA1c (6.5%) for diagnosis of diabetes.
12 Weeks
Level of Happiness
Time Frame: 12 Weeks
Oxford happiness questionnaire has been a widely adopted tool for measuring quality of life and happiness index. The assessed reliability by test-retest after 3 weeks using Oxford happiness questionnaire has been 79% .
12 Weeks
Body Mass Index
Time Frame: 12 Weeks
Body Mass Index is a reliable indicator of body fat based on height and weight of an adult. These BMI values can be calculated free by using online calculators available at NHS (UK) and NHLBI (USA).
12 Weeks

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jawad Naweed, MS-SPT, 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.
October 28, 2022

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.
May 5, 2023

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.
June 8, 2023

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).
May 3, 2023

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.
May 3, 2023

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.
May 11, 2023

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.
July 19, 2023

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.
July 18, 2023

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.
July 1, 2023

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/01412 SADIA MUNAWAR

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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