HealthyNCT05706948
High Intensity Interval Training on Cardiopulmonary Parameters With or Without Facemask in Healthy Participants
A study testing High Intensity Interval Training (With Face Mask) and High Intensity Interval Training (Without Face Mask) in people with Healthy, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High Intensity Interval Training (With Face Mask) and High Intensity Interval Training (Without Face Mask)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2023to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non smoker
- Free of any heart and lung diseases
- Passed Physical Activity Readiness Questionnaire PAR-Q
- To be able to do exercise
Who cannot join
- Any physical limitation that restrict exercise
- Any neurological illness
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Islamabad Medical & Surgical Hospital
Islamabad, Fedral, 44000
About this study
Official title: Effects of High Intensity Interval Training on Cardiopulmonary Parameters With or Without Facemask in Healthy Participants
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
- Conditions
- Healthy
- Being tested
- High Intensity Interval Training (With Face Mask), High Intensity Interval Training (Without Face Mask)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (With Face Mask)Other
High Intensity Interval Training on Treadmill for 4 weeks with Face mask
High Intensity Interval Training (Without Face Mask)Other
High Intensity Interval Training on Treadmill for 4 weeks with out Face mask
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (With Face Mask) | Experimental | Not described Receives: Other: High Intensity Interval Training (With Face Mask) |
| High Intensity Interval Training (Without Face Mask) | Experimental | Not described Receives: Other: High Intensity Interval Training (Without Face Mask) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse
Changes from the baseline, Pulse will be measured in Beats per minutes with Pulse oximeter.
Measured: 4 weeks
Oxygen saturation
Changes from the baseline, Oxygen saturation will be measured in Percentages with pulse oximeter
Measured: 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
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: 4 weeks
Waist to hip ratio
Waist to hip ratio is defined as a ratio of circumference of waist to that of hip.
Measured: 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
Measured: 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.
Measured: 4 weeks
Peak Expiratory Flow
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Peak Expiratory Flow in Liters.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start15 Feb 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706948
- Sponsor's protocol ID
- REC/01370 Muneeba Fatima Tariq
- Status last verified
- Jul 2023
- First submitted
- 22 Jan 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Interval Training on Cardiopulmonary Parameters With or Without Facemask in Healthy Participants
- ClinicalTrials.gov ID
- NCT05706948
- Acronym / sponsor ID
- REC/01370 Muneeba Fatima Tariq
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non smoker
- Free of any heart and lung diseases
- Passed Physical Activity Readiness Questionnaire PAR-Q
- To be able to do exercise
Key exclusion criteria (2 listed)
- Any physical limitation that restrict exercise
- Any neurological illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training (With Face Mask)High Intensity Interval Training on Treadmill for 4 weeks with Face mask | Other | High Intensity Interval Training (With Face Mask) |
| High Intensity Interval Training (Without Face Mask)High Intensity Interval Training on Treadmill for 4 weeks with out Face mask | Other | High Intensity Interval Training (Without Face Mask) |
Primary outcome
Pulse
Time frame: 4 weeks
Changes from the baseline, Pulse will be measured in Beats per minutes with Pulse oximeter.
Oxygen saturation
Time frame: 4 weeks
Changes from the baseline, Oxygen saturation will be measured in Percentages with pulse oximeter
Waist circumference
Time frame: 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
Modified BORG Scale
Time frame: 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
Vo2 Max
Time frame: 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.
Body Mas Index
Time frame: 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).
Hip circumference
Time frame: 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.
Waist to hip ratio
Time frame: 4 weeks
Waist to hip ratio is defined as a ratio of circumference of waist to that of hip.
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 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
Forced vital Capacity (FVC)
Time frame: 4 weeks
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Peak Expiratory Flow
Time frame: 4 weeks
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Peak Expiratory Flow in Liters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (With Face Mask) and High Intensity Interval Training (Without Face Mask) in people with Healthy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse (time frame: 4 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.