NCT05854797

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

May 3, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

Blood PressureBlood GlucoseWalkingBody Mass IndexPhysical ActivityExercise

Outcome Measures

Primary Outcomes (5)

  • Body Fat

    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

    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

    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

    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

    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

Study Arms (2)

Normal Walking Group

ACTIVE COMPARATOR

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

Brisk Walking Group

EXPERIMENTAL

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

Interventions

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)

Normal 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. 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)

Brisk Walking Group

Eligibility Criteria

Age36 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Polymed

Lahore, Punjab Province, O5499, Pakistan

Location

MeSH Terms

Conditions

OverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jawad Naweed, MS-SPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 11, 2023

Study Start

October 28, 2022

Primary Completion

May 5, 2023

Study Completion

June 8, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations