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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05145088
Study type Interventional
Source Foundation University Islamabad
Contact Dr Summyia Siddique Malik, MSPT
Phone +923208550611
Email summyia.siddique@fui.edu.pk
Status Recruiting
Phase N/A
Start date September 30, 2020
Completion date March 1, 2022