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

NCT ID: NCT05145088

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-03-01

Brief Summary

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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

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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.

Conditions

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Overweight and Obese Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants are randomly allocated by coin toss method in two groups and they are unawre of random allocation.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

submaximal exercise testing according to ACSM guidelines

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation University Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Summyia Siddique Malik, MSPT

Role: PRINCIPAL_INVESTIGATOR

Foundation University Islamabad

Dr Sanna Pervaiz, MSPT

Role: PRINCIPAL_INVESTIGATOR

Foundation University Islamabad

Locations

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Foundation University Islamabad

Islamabad, Federal, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Dr Summyia Siddique Malik, MSPT

Role: CONTACT

Phone: +923208550611

Email: [email protected]

Facility Contacts

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Dr Summyia

Role: primary

Other Identifiers

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FUI/CTR/2021/3

Identifier Type: -

Identifier Source: org_study_id