NCT05854732

Brief Summary

The goal of this clinical trial is to compare the effects of inclined and uninclined treadmill training on total body fat, lipid profile and quality of life in obese adults. The main question it aims to answer is : Will there be difference between the effectiveness of inclined and uninclined treadmill training on total body fat, lipid profile and quality of life in obese adults. Participants will be divided into group A and Group B. Group A participants will be considered as a control group with no inclination of the treadmill and speed of 5.0 mph. Whereas Group B participants will be considered as an interventional group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable obesity

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

October 27, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
8 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

5 months

First QC Date

May 3, 2023

Last Update Submit

July 18, 2023

Conditions

Obesity

Keywords

Quality of LifeCholesterolExercisePhysical ActivityLipid ProfileObesityTreadmill

Outcome Measures

Primary Outcomes (4)

  • Total Body Fat

    To estimate the overall amount of body fat, the skinfold thickness is measured using a skinfold caliper. This approach is predicated on the idea that subcutaneous fat is measured by the thickness of the skinfold and that body fat is distributed evenly throughout the body. Four skinfolds are measured in order to determine how much body fat is present overall that includes Biceps muscle fold, Thoracic skinfold, Skinfold on the sub scapula and iliac crest skinfold.

    6 Weeks

  • Body Mass Index

    A scale or balance is a tool used to determine mass or weight.

    6 Weeks

  • Lipid Profile Level (cholesterol and triglycerides)

    The lipid profile test that is used to check amount of cholesterol and triglycerides in blood.

    6 weeks

  • Quality of Life Questionnaire

    The WHOQOL, a tool that measures subjective dimensions of quality of life, was created by the World Health Organization (WHO). One of the most well-known tools for comparing quality of life across cultures is the WHOQOL-BREF, which is accessible in more than 40 languages.Each individual question on the WHOQOL-BREF is graded on a response scale, which is defined as a five-point ordinal scale, with scores ranging from 1 to 5. The scores are then linearly translated to a scale from 0 to 100. The mobility, everyday activities, functional ability, energy, pain, and sleep are all part of the physical health domain that are included in the WHOQOL.

    6 Weeks

Study Arms (2)

Inclined Treadmill Training Group

EXPERIMENTAL

The Inclined Treadmill Training Group will be considered as an Experimental group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute. The FITT program for the participants will be: * Warmup: 5 mints * Frequency: 5days/week for 4 weeks. * Intensity: fixed speed of 5.0 mph and increased inclination of 1% after every one minute. * Time: 30 minutes * Type: 1% Inclined treadmill * Cool down: 5 mints

Other: Inclined Treadmill Training

Uninclined Treadmill Training Group

ACTIVE COMPARATOR

The uninclined Treadmill Training Group will be considered as active comparator with no inclination of the treadmill and speed of 5.0 mph. The FIIT program for the participants will be: * Warmup: 5 mints * Frequency: 5days/week for 4 weeks. * Intensity fixed speed of 5.0 mph and no inclination. * Time: 30 minutes * Type: uninclined treadmill * Cool down: 5 mints

Other: Uninclined Treadmill Training

Interventions

Inclined Treadmill TrainingOTHER

Research subjects will be included in the study according to the inclusion criteria and would be randomized into 2 groups, namely inclined treadmill training group and uninclined treadmill training group and will receive intervention for 6 weeks. The participants will be considered as a experimental group with fixed speed of 5.0 mph and increased inclination of 1% after every one minute. FIIT FORMULA will be considered while providing intervention for 5 days per week to the subjects of each group. The FITT program for the participants will be starting with Warmup of 5 mints with Frequency of 5days/week for 6 weeks with fixed speed of 5.0 mph and increased inclination of 1% after every one minute for 30 minutes ending with Cool down for 5 minutes.

Inclined Treadmill Training Group
Uninclined Treadmill TrainingOTHER

Research subjects will be included in the study according to the inclusion criteria and would be randomized into 2 groups, namely inclined treadmill training group and uninclined treadmill training group and will receive intervention for 6 weeks. The participants will be considered as a active comparator with fixed speed of 5.0 mph and fixed inclination. FIIT FORMULA will be considered while providing intervention for 5 days per week to the subjects of each group. The FITT program for the participants will be starting with Warmup of 5 mints with Frequency of 5days/week for 6 weeks with fixed speed of 5.0 mph and fixed inclination for 30 minutes ending with Cool down for 5 minutes.

Uninclined Treadmill Training Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants falling in this category would be recruited into the study.
  • Males \& females
  • Body Mass Index (BMI)\> 30 kg / m2 (10).
  • Age: 18-25
  • Physically independent
  • Body fat percentage \> 25%

You may not qualify if:

  • Participant failing to fall in this category would be excluded of the study.
  • Pregnancy
  • Nutrition
  • Steroid injections in last 6 months
  • Psychomotor dysfunction
  • Any infection.
  • Any neurological and musculoskeletal problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yusra Medical and Dental College

Islamabad, Federal, 44080, Pakistan

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition 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 27, 2022

Primary Completion

March 15, 2023

Study Completion

June 8, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)