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

Primary Purpose

Overweight and Obese Adults

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
submaximal exercise testing according to ACSM guidelines
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obese Adults

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Foundation University IslamabadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

VO2 max
It is going to measure the aerobic capacity of the individuals.
VO2 max
It is going to measure the aerobic capacity of the individuals.

Secondary Outcome Measures

BMI
Change in BMI after submaximal exercise training
BMI
Change in BMI after submaximal exercise training of 3 weeks.

Full Information

First Posted
November 3, 2021
Last Updated
December 3, 2021
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05145088
Brief Title
Association Analysis of Aerobic Capacity and Expiratory Forced Vital Capacity in Overweight and Obese Adults After Submaximal Exercise Training of Three Weeks
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Objectives of study: To find out association between aerobic capacity and expiratory forced vital capacity in overweight obese adults after submaximal exercise training of 03 weeks. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obese Adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are randomly allocated by coin toss method in two groups and they are unawre of random allocation.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
submaximal exercise testing according to ACSM guidelines
Intervention Description
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
Primary Outcome Measure Information:
Title
VO2 max
Description
It is going to measure the aerobic capacity of the individuals.
Time Frame
Day 1
Title
VO2 max
Description
It is going to measure the aerobic capacity of the individuals.
Time Frame
3rd week
Secondary Outcome Measure Information:
Title
BMI
Description
Change in BMI after submaximal exercise training
Time Frame
Day 1
Title
BMI
Description
Change in BMI after submaximal exercise training of 3 weeks.
Time Frame
3rd week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Young adults between age 18 to 35 years Classified Overweight and obese adults according to their BMI Exclusion criteria: Any prior history of chronic respiratory illness and chronic cardiac disease. Individuals belonging to certain occupations like coal miners, hard rock miners, tunnel workers, concrete manufacturing workers and non-mining industrial workers. Individuals with any diagnosed musculoskeletal disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Summyia Siddique Malik, MSPT
Phone
+923208550611
Email
summyia.siddique@fui.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Summyia Siddique Malik, MSPT
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Sanna Pervaiz, MSPT
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Islamabad
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Summyia
Email
summyia.siddique@fui.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

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

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