ObesityNCT05618899
Effect of Exercises on Physical Health and Cardiorespiratory Fitness in Obese Women
A study testing HIGH INTENSITY INTERVAL TRAINING and MODERATE INTENSITY EXERCISE in people with Obesity, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be a Randomized clinical trial and will be conducted in services hospital lahore. The sample size of 50 patients will be taken in this study to find the effects of high intensity interval training versus moderate intensity exercises on physical health and cardiorespiratory fitness in obese women. Read more about this study
- Who is it for?
- Ages 17 to 30 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- HIGH INTENSITY INTERVAL TRAINING and MODERATE INTENSITY EXERCISE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2022to 20 Feb 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 17 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women between the ages of 17-30 years
- BMI 25-35kg/m2.
- Sedentary (< 30 minutes of structured activity per week)
- Normal glucose tolerance ( fasting glucose <100mg/dL)
- No use of medications known to affect body composition or metabolism
- All participants will be non smoker
Show all 9Show fewer
- No MI history
- No previous surgery.
- Free from known injury or known clinical conditio
Who cannot join
- BMI < 30 kg/m2 Known clinical condition including family history of sudden death, uncontrolled hypertension, type 1 and type 2 diabetes and cardiovascular diesease. • Participants will be excluded if they report in competitive exericise
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ittefaq Hospital
Lahore, Punjab Province, 54000
madiha younas, MS, 0333-8148025, madiha.younas@riphah.edu.pk
Maham athar, MSCPPT
About this study
Official title: Effect oh High Intensity Interval Training Versus Moderate Intensity Exercises on Physical Health and Cardiorespiratory Fitness in Obeses Women
The study will be a Randomized clinical trial and will be conducted in services hospital lahore. The sample size of 50 patients will be taken in this study to find the effects of high intensity interval training versus moderate intensity exercises on physical health and cardiorespiratory fitness in obese women.
Patients will be divided into two groups (Group A will be treated with high intensity interval training and Group B will be treated with moderate intensity exercises). Eligible participants attended three session per week. Overnight fast, resting metabolic rate and blood pressure will be assessed. An oral glucose test will be assessed and baseline blood samples will be used for lipoprotein analysis. Pacer test and step test performed in the each session. A regular follow-up visits to department and a final assessment will be made at the end of last week by using questionnaire and resulting improvement will shown in results after completion. Data will be analyzed on SPSS 25.
Read the detailed description
The study will be a Randomized clinical trial and will be conducted in services hospital lahore. The study will be completed within the duration of ten months. Non probability convenient sampling study technique will be used to collect the data. The sample size of 50 patients will be taken in this study to find the effects of high intensity interval training versus moderate intensity exercises on physical health and cardiorespiratory fitness in obese women.
Patients will be divided into two groups (Group A will be treated with high intensity interval training and Group B will be treated with moderate intensity exercises). Eligible participants attended three session per week. Overnight fast, resting metabolic rate and blood pressure will be assessed. An oral glucose test will be assessed and baseline blood samples will be used for lipoprotein analysis. Pacer test and step test performed in the each session. A regular follow-up visits to department and a final assessment will be made at the end of last week by using questionnaire and resulting improvement will shown in results after completion. Data will be analyzed on SPSS 25.
- Conditions
- Obesity
- Being tested
- HIGH INTENSITY INTERVAL TRAINING, MODERATE INTENSITY EXERCISE
- Keywords
- High intensity exercise, Moderate intensity exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIGH INTENSITY INTERVAL TRAININGOther
Training should be done on treadmill for 25-30 minutes.. Training proceed for 1 month once a day
MODERATE INTENSITY EXERCISEOther
moderate intensity exercises consist of generally 30-60 minutes of aerobic exercises at 64-76% of peak heart rate. Training should be done on treadmill for 30-60 minutes. Training proceed for 1 month once a day
| Study group | Role | What they receive |
|---|---|---|
| HIGH INTENSITY INTERVAL TRAINING | Experimental | High intensity interval training basicaaly short bursts of intense exercise alternating with low intensity recovery periods. Training should be done on treadmill for 25-30 minutes.. Training proceed for 1 month once a day Receives: Other: HIGH INTENSITY INTERVAL TRAINING |
| MODERATE INTENSITY EXERCISE | Experimental | moderate intensity exercises consist of generally 30-60 minutes of aerobic exercises at 64-76% of peak heart rate. Training should be done on treadmill for 30-60 minutes. Training proceed for 1 month once a day Receives: Other: MODERATE INTENSITY EXERCISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step test
the step test is designed to measured a person's aerobic fitness. Participants steps up and down, on and off, an aerobics- type step for three minutes to increase heart rate and to evaluate the heart's recovery rate during the minute immediately following the step test exercise.
Measured: 4weeks
Glucose tolerance test
The glucose tolerance test is a medical test in which glucose is given and blood samples taken afterward to determine how quickly it is cleared from the blood. The test is usually used to test for diabetes, insulin resistance. an oral glucose tolerance test (OGTT), a standard dose of glucose is ingested by mouth and blood levels are checked two hours later.
Measured: 4weeks
Lipoprotein blood test:
lipoprotein test measures the level of lipoprotein in your blood. Lipoproteins are substances made of protein and fat that carry cholesterol through your bloodstream. Lipoprotein (a) is a type of LDL (bad) cholesterol. A high level of lipoprotein
(a) may mean you are at risk for heart disease.
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 May 2022
- Primary completionFeb 2023 (estimated)
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- madiha younas, MS, Principal investigator, riphah internationl university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618899
- Sponsor's protocol ID
- REC/22/0343 MAHAM ATHAR
- Status last verified
- Jan 2023
- First submitted
- 8 Nov 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect oh High Intensity Interval Training Versus Moderate Intensity Exercises on Physical Health and Cardiorespiratory Fitness in Obeses Women
- ClinicalTrials.gov ID
- NCT05618899
- Acronym / sponsor ID
- REC/22/0343 MAHAM ATHAR
- Conditions
- Obesity
- Keywords
- High intensity exercise, Moderate intensity exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 16 Nov 2022 (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.
The study will be a Randomized clinical trial and will be conducted in services hospital lahore. The sample size of 50 patients will be taken in this study to find the effects of high intensity interval training versus moderate intensity exercises on physical health and cardiorespiratory fitness in obese women.
Patients will be divided into two groups (Group A will be treated with high intensity interval training and Group B will be treated with moderate intensity exercises). Eligible participants attended three session per week. Overnight fast, resting metabolic rate and blood pressure will be assessed. An oral glucose test will be assessed and baseline blood samples will be used for lipoprotein analysis. Pacer test and step test performed in the each session. A regular follow-up visits to department and a final assessment will be made at the end of last week by using questionnaire and resulting improvement will shown in results after completion. Data will be analyzed on SPSS 25.
Detailed description
The study will be a Randomized clinical trial and will be conducted in services hospital lahore. The study will be completed within the duration of ten months. Non probability convenient sampling study technique will be used to collect the data. The sample size of 50 patients will be taken in this study to find the effects of high intensity interval training versus moderate intensity exercises on physical health and cardiorespiratory fitness in obese women.
Patients will be divided into two groups (Group A will be treated with high intensity interval training and Group B will be treated with moderate intensity exercises). Eligible participants attended three session per week. Overnight fast, resting metabolic rate and blood pressure will be assessed. An oral glucose test will be assessed and baseline blood samples will be used for lipoprotein analysis. Pacer test and step test performed in the each session. A regular follow-up visits to department and a final assessment will be made at the end of last week by using questionnaire and resulting improvement will shown in results after completion. Data will be analyzed on SPSS 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIGH INTENSITY INTERVAL TRAINING | Experimental | Other: HIGH INTENSITY INTERVAL TRAININGHigh intensity interval training basicaaly short bursts of intense exercise alternating with low intensity recovery periods. Training should be done on treadmill for 25-30 minutes.. Training proceed for 1 month once a day |
| MODERATE INTENSITY EXERCISE | Experimental | Other: MODERATE INTENSITY EXERCISEmoderate intensity exercises consist of generally 30-60 minutes of aerobic exercises at 64-76% of peak heart rate. Training should be done on treadmill for 30-60 minutes. Training proceed for 1 month once a day |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Women between the ages of 17-30 years
Key exclusion criteria (1 listed)
- BMI < 30 kg/m2 Known clinical condition including family history of sudden death, uncontrolled hypertension, type 1 and type 2 diabetes and cardiovascular diesease. • Participants will be excluded if they report in competitive exericise
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 TRAININGTraining should be done on treadmill for 25-30 minutes.. Training proceed for 1 month once a day | Other | HIGH INTENSITY INTERVAL TRAINING |
| MODERATE INTENSITY EXERCISEmoderate intensity exercises consist of generally 30-60 minutes of aerobic exercises at 64-76% of peak heart rate. Training should be done on treadmill for 30-60 minutes. Training proceed for 1 month once a day | Other | MODERATE INTENSITY EXERCISE |
Primary outcome
Step test
Time frame: 4weeks
the step test is designed to measured a person's aerobic fitness. Participants steps up and down, on and off, an aerobics- type step for three minutes to increase heart rate and to evaluate the heart's recovery rate during the minute immediately following the step test exercise.
Glucose tolerance test
Time frame: 4weeks
The glucose tolerance test is a medical test in which glucose is given and blood samples taken afterward to determine how quickly it is cleared from the blood. The test is usually used to test for diabetes, insulin resistance. an oral glucose tolerance test (OGTT), a standard dose of glucose is ingested by mouth and blood levels are checked two hours later.
Lipoprotein blood test:
Time frame: 4weeks
lipoprotein test measures the level of lipoprotein in your blood. Lipoproteins are substances made of protein and fat that carry cholesterol through your bloodstream. Lipoprotein (a) is a type of LDL (bad) cholesterol. A high level of lipoprotein (a) may mean you are at risk for heart disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
madiha younas, MS principal investigator
riphah internationl 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 and MODERATE INTENSITY EXERCISE in people with Obesity, 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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step test (time frame: 4weeks). The study lists 3 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 25 Jan 2023.