High Intensity Interval Training on Cardiopulmonary Parameters With or Without Facemask in Healthy Participants

• Sponsor: Riphah International University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05706948
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 21.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: High Intensity Interval Training (With Face Mask); Other: High Intensity Interval Training (Without Face Mask)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effects of High Intensity Interval Training on Cardiopulmonary Parameters With or Without Facemask in Healthy Participants
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Intensity Interval Training (With Face Mask)	Other: High Intensity Interval Training (With Face Mask); High Intensity Interval Training on Treadmill for 4 weeks with Face mask
Experimental: High Intensity Interval Training (Without Face Mask)	Other: High Intensity Interval Training (Without Face Mask); High Intensity Interval Training on Treadmill for 4 weeks with out Face mask

Outcome Measures

Primary Outcome Measures

1. Pulse [4 weeks]

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

2. Oxygen saturation [4 weeks]

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

3. Waist circumference [4 weeks]

   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. Modified BORG Scale [4 weeks]

   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

5. Vo2 Max [4 weeks]

   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.

6. Body Mas Index [4 weeks]

   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).

7. Hip circumference [4 weeks]

   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.

8. Waist to hip ratio [4 weeks]

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

9. Forced Expiratory Volume in 1 second (FEV1) [4 weeks]

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

10. Forced vital Capacity (FVC) [4 weeks]

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

11. Peak Expiratory Flow [4 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Non smoker

• Free of any heart and lung diseases

• Passed Physical Activity Readiness Questionnaire PAR-Q

• To be able to do exercise

Exclusion Criteria:

• Any physical limitation that restrict exercise

• Any neurological illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Islamabad Medical & Surgical Hospital	Islamabad	Fedral	Pakistan	44000

Sponsors and Collaborators

• Riphah International University

Investigators

• Principal Investigator: Muhammad Iqbal Tariq, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05706948
• Other Study ID Numbers: REC/01370 Muneeba Fatima Tariq
• First Posted: Jan 31, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 31, 2023