ObesityNCT04382742
Exercise Response on Dose Curve Among Class I Obese Young Adult Population
A study testing Dynamic Resistance Exercises in people with Obesity, run by Ziauddin University at 1 site in Pakistan.
Trial summary
The study is aimed to determine impact of dynamic resistance exercise training on Body Fat percentage of class-I Obese population and to quantify the dose of exercise program using a probit regression curve Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dynamic Resistance Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Dec 2019to 15 Apr 2020
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Class I obese population BMI 30 -39.9
- Young adults of age 20-40 years
- Male and female population
Who cannot join
- • Recent surgery that limits participation in exercise program
- Known Cardia Disease
- Any comorbidity that limits participation in training program
Trial locations and contacts
1 site in 1 country.
About this study
The study is aimed to determine impact of dynamic resistance exercise training on Body Fat percentage of class-I Obese population and to quantify the dose of exercise program using a probit regression curve
Read the detailed description
Methodology
A sample size of 34 participants 17 male and 17 female of aged between 20-40 years with class-I obesity were selected and recruited in this study. All the participants were initially screened using a physical activity and readiness questionnaire to determine if they are fit to perform exercises afterwards intervention based on dynamic exercises were given to the patient for 12 weeks based on the guidelines of American College of Sports Medicine and the quantification of exercises was done using a Frequency, Intensity, Time and Type (FITT) protocol. The training session was based on Warm up 5 to 10 minutes followed by conditioning phase of 20 minutes and a cool down phase of 5 to 10 minutes. The detailed description of each of the phase is as under:
Warm up Phase Dynamic light aerobic warm up exercises were performed by the participants for 5 to 10 minutes before the start of the conditioning. Two different exercises that were performed included i) High Knee in which the knees will be lifted as high as possible in such a manner that both feet should be at one time be above the ground ii) Jumping Jack Exercise in which a simultaneous movement of upper and lower limb will be performed in a manner that every time during a jump the arms were thrusted over the head while the foot moved out to the side and than returning back to the original position 10 repetitions of both the exercises were performed.
Dynamic Resistance Exercise Modified Wingate protocol that incorporates 20 minutes of training on a cycle ergometer; included one minute of cycling with resistance to be performed at 85% to 90% of Maximal Heart Rate (MHR) followed by one minute of cycling with no resistance. The protocol will be performed for 10 times for a duration of 20 minute of workout.
Cool Down The process of cool down last for 5-10 minutes. During this low intensity, long hold stretching were performed of lower limb and upper limb that included shoulder, calf and hamstring stretch
- Conditions
- Obesity
- Being tested
- Dynamic Resistance Exercises
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Resistance ExercisesBehavioural
Modified Wingate protocol that incorprates 20 minutes of training on a cycle ergometer; included one minute of cycling with resistance to be performed at 85% to 90% of Maximal Heart Rate (MHR) followed by one minute of cycling with no resistance. The protocol will be performed for 10 times for a duration of 20 minute of workout.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Dynamic Resistance Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat Percentage (Pre treatment)
Body fat percentage is used to measure fat mass with higher percentage revealing greater body fat. The values are calculated using skin fold thickness (precision caliper) method.
Measured: Baseline
Body Fat Percentage (Post treatment)
Body fat percentage is used to measure fat mass with higher percentage revealing greater body fat. The values are calculated using skin fold thickness (precision caliper) method.
Measured: After 12 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start15 Dec 2019
- Primary completion1 Mar 2020
- Study completion15 Apr 2020
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Batool Hassan, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382742
- Sponsor's protocol ID
- BatoolH
- Status last verified
- May 2020
- First submitted
- 1 May 2020
- Last updated
- 11 May 2020
- 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 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Response on Dose Curve Among Class I Obese Young Adult Population
- ClinicalTrials.gov ID
- NCT04382742
- Acronym / sponsor ID
- BatoolH
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 11 May 2020 (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 is aimed to determine impact of dynamic resistance exercise training on Body Fat percentage of class-I Obese population and to quantify the dose of exercise program using a probit regression curve
Detailed description
Methodology
A sample size of 34 participants 17 male and 17 female of aged between 20-40 years with class-I obesity were selected and recruited in this study. All the participants were initially screened using a physical activity and readiness questionnaire to determine if they are fit to perform exercises afterwards intervention based on dynamic exercises were given to the patient for 12 weeks based on the guidelines of American College of Sports Medicine and the quantification of exercises was done using a Frequency, Intensity, Time and Type (FITT) protocol. The training session was based on Warm up 5 to 10 minutes followed by conditioning phase of 20 minutes and a cool down phase of 5 to 10 minutes. The detailed description of each of the phase is as under:
Warm up Phase Dynamic light aerobic warm up exercises were performed by the participants for 5 to 10 minutes before the start of the conditioning. Two different exercises that were performed included i) High Knee in which the knees will be lifted as high as possible in such a manner that both feet should be at one time be above the ground ii) Jumping Jack Exercise in which a simultaneous movement of upper and lower limb will be performed in a manner that every time during a jump the arms were thrusted over the head while the foot moved out to the side and than returning back to the original position 10 repetitions of both the exercises were performed.
Dynamic Resistance Exercise Modified Wingate protocol that incorporates 20 minutes of training on a cycle ergometer; included one minute of cycling with resistance to be performed at 85% to 90% of Maximal Heart Rate (MHR) followed by one minute of cycling with no resistance. The protocol will be performed for 10 times for a duration of 20 minute of workout.
Cool Down The process of cool down last for 5-10 minutes. During this low intensity, long hold stretching were performed of lower limb and upper limb that included shoulder, calf and hamstring stretch
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Dynamic Resistance Exercises |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Class I obese population BMI 30 -39.9
Key exclusion criteria (3 listed)
- • Recent surgery that limits participation in exercise program
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 |
|---|---|---|
| Dynamic Resistance ExercisesModified Wingate protocol that incorprates 20 minutes of training on a cycle ergometer; included one minute of cycling with resistance to be performed at 85% to 90% of Maximal Heart Rate (MHR) followed by one minute of cycling with no resistance. The protocol will be performed for 10 times for a duration of 20 minute of workout. | Behavioural | Exercise |
Primary outcome
Body Fat Percentage (Pre treatment)
Time frame: Baseline
Body fat percentage is used to measure fat mass with higher percentage revealing greater body fat. The values are calculated using skin fold thickness (precision caliper) method.
Body Fat Percentage (Post treatment)
Time frame: After 12 weeks of training
Body fat percentage is used to measure fat mass with higher percentage revealing greater body fat. The values are calculated using skin fold thickness (precision caliper) method.
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 11 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Resistance Exercises in people with Obesity, run by Ziauddin 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 3 inclusion and 3 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 11 May 2020. 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?
Body Fat Percentage (Pre treatment) (time frame: Baseline). The study lists 2 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 11 May 2020.