Association Analysis of Aerobic Capacity and Expiratory Forced Vital Capacity in Overweight and Obese Adults After Submaximal Exercise Training of Three Weeks

Association Analysis of Aerobic Capacity and Expiratory Forced Vital Capacity in Overweight and Obese Adults After Submaximal Exercise Training of Three Weeks (a Randomized Controlled Trial Study)

It is a randomized controlled trial. The study is initiated after getting an approval from ERC FUI. The research is being conducted according to ethical guidelines of Pakistan Medical Research Council and declaration of Helsinki. Confidentiality and anonymity of participants is being maintained throughout the research project. Study subjects are being selected on the basis of inclusion and exclusion criteria and then are being randomly allocated on the basis of coin toss method in Control and experimental groups. An informed consent is being taken from study participants prior to recruiting in study. After random allocation the participants are being given self-administered PAR-Q followed by pre exercise Expiratory forced vital capacity and VO2 max measurements through Digital spirometer and McArdle Katch test respectively. Then study participants will be made to perform submaximal exercise testing according to ACSM guidelines for 03 weeks. The data will be collected at two time intervals that is on day 1 and then after 03 weeks. Data will then be analyzed using SPSS version 21.0.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obese Adults
• Intervention / Treatment: Behavioral: submaximal exercise testing according to ACSM guidelines

Detailed Description

Objectives of study:

1. To find out association between aerobic capacity and expiratory forced vital capacity in overweight obese adults after submaximal exercise training of 03 weeks.
2. To find out effectiveness of submaximal exercise training of 03 weeks on aerobic capacity and expiratory forced vital capacity in overweight obese adults.

STUDY HYPOTHESIS

Alternate hypothesis: There is a significant association between aerobic capacity and expiratory forced vital capacity in overweight obese adults Null hypothesis: There is no significant association between aerobic capacity and expiratory forced vital capacity in overweight obese adults MATERIAL & METHODS

STUDY DESIGN: Randomized control trial SETTING: FUIRS clinical lab DURATION OF STUDY: 1.5 years SAMPLE SIZE: N=30 (sample size validated through tool)

SAMPLING TECHNIQUE: Non probability convenient sampling

Outcome Measures:

Data will be collected on Demographics and general information. VO2 max is being assessed with the help of McArdle Katch test. FVC is being assesed with the help of hand held spirometer device.

Experimental Group (A) = 03 weeks of submaximal exercise according to ACSM guidelines.

Control group (B) =this group is under control with no exercise training.

Data analysis techniques:

The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community.

An informed consent is being taken from study participants prior to recruiting in study. After random allocation the participants are being given self-administered PAR-Q followed by pre exercise Expiratory forced vital capacity and VO2 max measurement by the PI.

Significance of study:

This study will make people become aware of their current physical fitness level, so the lifestyle behaviors can be modified if needed, in order to improve their quality of life This study will open new doors for researchers to do long term studies by using different parametes of lungs function test available in hand held spirometer.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Summyia Siddique Malik, MSPT; Phone Number: +923208550611; Email: summyia.siddique@fui.edu.pk

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 46000
      • Recruiting
      • Foundation University Islamabad
      • Contact: Dr Summyia; Email: summyia.siddique@fui.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Young adults between age 18 to 35 years
2. Classified Overweight and obese adults according to their BMI

Exclusion criteria:

1. Any prior history of chronic respiratory illness and chronic cardiac disease.
2. Individuals belonging to certain occupations like coal miners, hard rock miners, tunnel workers, concrete manufacturing workers and non-mining industrial workers.
3. Individuals with any diagnosed musculoskeletal disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The participants in this group are under control and not perfoming any exercise, and their life style is NOT consistent with any kind of submaximal exercise training designed as per protocol.
Experimental: Experimental group; the particpants are made to perform submaximal exercise testing according to ACSM guidelines for 03 weeks. For Moderate-intensity exercises includes either 30 min a day for five days a week or a total of two hours and 30 min per week using 50% to 70% of maximum heart rate. The data will be calculated at two times in the form of pre and post testing.	Behavioral: submaximal exercise testing according to ACSM guidelines; For Moderate-intensity exercises includes either 30 min a day for five days a week or a total of two hours and 30 min per week using 50% to 70% of maximum heart rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max	It is going to measure the aerobic capacity of the individuals.	Day 1
VO2 max	It is going to measure the aerobic capacity of the individuals.	3rd week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Change in BMI after submaximal exercise training	Day 1
BMI	Change in BMI after submaximal exercise training of 3 weeks.	3rd week

Collaborators and Investigators

• Sponsor: Foundation University Islamabad
• Investigators: Principal Investigator: Dr Summyia Siddique Malik, MSPT, Foundation University Islamabad; Principal Investigator: Dr Sanna Pervaiz, MSPT, Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: FUI/CTR/2021/3

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