Clinical trial NCT05145088: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obese Adults
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: VO2 max
timeFrame: Day 1
measure: VO2 max
timeFrame: 3rd week
Secondary outcomes:
measure: BMI
timeFrame: Day 1
measure: BMI
timeFrame: 3rd week
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Islamabad
state: Federal
Study officials:
affiliation: Foundation University Islamabad
name: Dr Summyia Siddique Malik, MSPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundation University Islamabad
name: Dr Sanna Pervaiz, MSPT
role: PRINCIPAL_INVESTIGATOR
References: