NCT05706948

Brief Summary

To determine the effects of high intensity interval training on cardiovascular function, cardio metabolic markers and cardiorespiratory fitness in healthy individuals with or without facemask

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

January 22, 2023

Last Update Submit

July 7, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

  • Pulse

    Changes from the baseline, Pulse will be measured in Beats per minutes with Pulse oximeter.

    4 weeks

  • Oxygen saturation

    Changes from the baseline, Oxygen saturation will be measured in Percentages with pulse oximeter

    4 weeks

  • Waist circumference

    Waist circumference will be measured for abdominal or central fat mass. It is measured in cm at the middle distance between the last floating rib and the iliac crest using a retractable ergonomic measuring tape. Change from the baseline to 4 week will be compared

    4 weeks

  • Modified BORG Scale

    The Modified Borg Dyspnea Scale is numerical rating scale ranging from 0 to 10 and is used to measure dyspnea that patient report during sub-maximal exercise and is regularly administered during six-minute walk test. Changes from the baseline will be measured

    4 weeks

  • Vo2 Max

    Changes from the baseline ;The maximum or optimum rate at which the heart, lungs and muscles can effectively use oxygen during exercise, used as a way of measuring a person's individual aerobic capacity.

    4 weeks

  • Body Mas Index

    Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individual\'s height and weight to give an estimation of muscle versus fat in female and male of all ages. It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square).

    4 weeks

  • Hip circumference

    Hip measurement is an estimation of the hips, utilizing a measuring tape, for assessment of spatial distance between each relating hipbone with respect to the buttocks. Hip circumference can be a significant estimation in deciding combined muscle to fat ratio around the waist that might reflect sedentary lifestyle.

    4 weeks

  • Waist to hip ratio

    Waist to hip ratio is defined as a ratio of circumference of waist to that of hip.

    4 weeks

  • Forced Expiratory Volume in 1 second (FEV1)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

    4 weeks

  • Forced vital Capacity (FVC)

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.

    4 weeks

  • Peak Expiratory Flow

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Peak Expiratory Flow in Liters.

    4 weeks

Study Arms (2)

High Intensity Interval Training (With Face Mask)

EXPERIMENTAL
Other: High Intensity Interval Training (With Face Mask)

High Intensity Interval Training (Without Face Mask)

EXPERIMENTAL
Other: High Intensity Interval Training (Without Face Mask)

Interventions

High Intensity Interval Training (With Face Mask)OTHER

High Intensity Interval Training on Treadmill for 4 weeks with Face mask

High Intensity Interval Training (With Face Mask)
High Intensity Interval Training (Without Face Mask)OTHER

High Intensity Interval Training on Treadmill for 4 weeks with out Face mask

High Intensity Interval Training (Without Face Mask)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non smoker
  • Free of any heart and lung diseases
  • Passed Physical Activity Readiness Questionnaire PAR-Q
  • To be able to do exercise

You may not qualify if:

  • Any physical limitation that restrict exercise
  • Any neurological illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamabad Medical & Surgical Hospital

Islamabad, Fedral, 44000, Pakistan

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Iqbal Tariq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2023

First Posted

January 31, 2023

Study Start

February 15, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)