NCT05145088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

November 3, 2021

Last Update Submit

December 3, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • BMI

    Day 1

  • BMI

    3rd week

Study Arms (2)

Control Group

NO INTERVENTION

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 group

EXPERIMENTAL

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

Interventions

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

Experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults between age 18 to 35 years
  • Classified Overweight and obese adults according to their BMI

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Summyia Siddique Malik, MSPT

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR
  • Dr Sanna Pervaiz, MSPT

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Summyia Siddique Malik, MSPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are randomly allocated by coin toss method in two groups and they are unawre of random allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

December 6, 2021

Study Start

September 30, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

December 6, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations