Overweight and ObesityNCT04155827
Gender Specific Responses of Overweight and Obese Adults to Sprint Interval Training
A study testing SIT in people with Overweight and Obesity, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial summary
Overweight and Obesity is a growing health problem worldwide. Lifestyle changes such as decreased physical activity, increased sedentary behaviour and unhealthy eating habits has contribute to this problem. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- SIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMalaysia
- Study dates
- 4 Feb 2020to 23 Nov 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI≧23kg/m2(WHO for Asia-Pacific region)
- No history of metabolic, hormonal, orthopedic, or cardiovascular diseases
- No current use of prescribed medication including oral contraception
Who cannot join
- Contraindications to physical activity assessed by Physical Activity Readiness Questionnaire-PAR-Q
- Undergoes any surgical or hormone treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender Specific Responses of Overweight and Obese Adults to Sprint Interval Training on Anthropometric Variables
Overweight and Obesity is a growing health problem worldwide. Lifestyle changes such as decreased physical activity, increased sedentary behaviour and unhealthy eating habits has contribute to this problem. According to World Health Organization (2016), more than 1.9 billion adults aged 18 years and older were overweight (39% of men and 40% of women).Regular exercise is the key contributor to energy expenditure and is essential for energy balance and weight control. Interval training (IT) has been commonly used for decades with purpose to improve body health and reduce weight loss and this exercise differs from the conventional aerobic exercise and endurance exercise as IT typically involves repeated bouts of relatively intense exercise interspersed by periods of lower- intensity effort or complete rest for recovery. One of the most common type of IT is sprint interval training (SIT). SIT involves 'supramaximal' effort (>100% VO2max) work bouts, traditionally structured as four to six 30s all-out effort and each round separated by 4 minutes of recovery period of a low intensity exercise. Potential physiological adaptation of SIT are highlighted by various studies reporting cardiovascular, skeletal muscle adaptations, increase fat oxidation that facilitate increases in both aerobic and anaerobic performance. In addition, SIT is able to improve maximal rate of oxygen consumption (VO2max), at the same time improving the peripheral vascular structure and function, enzymes of fat metabolism and increases insulin sensitivity. Previous SIT studies have included young healthy men and women, healthy obese young women, all of which have shown that SIT is effective for fat loss and improvement of some health parameters. However, whether SIT protocol is equally effective in improving the anthropometric measures in men and women remain unknown.
Read the detailed description
Total of 80 eligible male (n=40) and female (n=40) young adults will be equally recruited using block randomization and chosen based on the inclusion and exclusion criteria. Before the study, all participants will be informed of the potential risks and benefits of the study. During the study period, participants will be instructed to avoid any form of physical activity besides the study protocol. Both groups will perform SIT protocol on a electromagnetically braked cycle ergometer three times per week for 6 weeks. Every session, participants start with a 5 minutes warm up at 50- 60% of heart rate maximum (HRmax) and follow by four 30-s all out bouts intersperse with 4 minutes of recovery (passive or no load cycling). For confirmation of all-out effort, participant are required to maintain his or her cycling cadence at least 60 rpm or above. Intervention will end with a 5 minutes cool down at 50- 60% of HRmax. Total duration for each session will be 28 minutes. If a participant misses fewer than three sessions per week non- consecutively, the sessions missed will be replace at the end of period. However, if participants misses three or more sessions, he or she will be excluded from the study. Outcome measures will be assessed at baseline and at end of 6 weeks of intervention.
- Conditions
- Overweight and Obesity
- Being tested
- SIT
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SITOther
Sprint interval training of 4*4, with 30 seconds of all out workout followed by 4 minutes of active recovery for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| SIT for males | Experimental | Not described Receives: Other: SIT |
| SIT for females | Experimental | Not described Receives: Other: SIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI for change
Measured: At baseline (before intervention begin) and post training (end of 6 weeks).
Waist Circumference for change
Measured: At baseline (before intervention begin) and post training (end of 6 weeks).
Total Fat % for change
Measured: At baseline (before intervention begin) and post training (end of 6 weeks).
Lean Muscle Mass for change
Measured: At baseline (before intervention begin) and post training (end of 6 weeks).
skin Fold Measurement for change
Measured: At baseline (before intervention begin) and post training (end of 6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start4 Feb 2020
- Primary completion16 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman
- Investigators
- Imtiyaz Ali Mir, Principal investigator, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155827
- Sponsor's protocol ID
- UMFB1001
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2019
- Last updated
- 24 Nov 2020
- Results posted
- 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 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Specific Responses of Overweight and Obese Adults to Sprint Interval Training on Anthropometric Variables
- ClinicalTrials.gov ID
- NCT04155827
- Acronym / sponsor ID
- UMFB1001
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 7 Nov 2019 (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.
Overweight and Obesity is a growing health problem worldwide. Lifestyle changes such as decreased physical activity, increased sedentary behaviour and unhealthy eating habits has contribute to this problem. According to World Health Organization (2016), more than 1.9 billion adults aged 18 years and older were overweight (39% of men and 40% of women).Regular exercise is the key contributor to energy expenditure and is essential for energy balance and weight control. Interval training (IT) has been commonly used for decades with purpose to improve body health and reduce weight loss and this exercise differs from the conventional aerobic exercise and endurance exercise as IT typically involves repeated bouts of relatively intense exercise interspersed by periods of lower- intensity effort or complete rest for recovery. One of the most common type of IT is sprint interval training (SIT). SIT involves 'supramaximal' effort (>100% VO2max) work bouts, traditionally structured as four to six 30s all-out effort and each round separated by 4 minutes of recovery period of a low intensity exercise. Potential physiological adaptation of SIT are highlighted by various studies reporting cardiovascular, skeletal muscle adaptations, increase fat oxidation that facilitate increases in both aerobic and anaerobic performance. In addition, SIT is able to improve maximal rate of oxygen consumption (VO2max), at the same time improving the peripheral vascular structure and function, enzymes of fat metabolism and increases insulin sensitivity. Previous SIT studies have included young healthy men and women, healthy obese young women, all of which have shown that SIT is effective for fat loss and improvement of some health parameters. However, whether SIT protocol is equally effective in improving the anthropometric measures in men and women remain unknown.
Detailed description
Total of 80 eligible male (n=40) and female (n=40) young adults will be equally recruited using block randomization and chosen based on the inclusion and exclusion criteria. Before the study, all participants will be informed of the potential risks and benefits of the study. During the study period, participants will be instructed to avoid any form of physical activity besides the study protocol. Both groups will perform SIT protocol on a electromagnetically braked cycle ergometer three times per week for 6 weeks. Every session, participants start with a 5 minutes warm up at 50- 60% of heart rate maximum (HRmax) and follow by four 30-s all out bouts intersperse with 4 minutes of recovery (passive or no load cycling). For confirmation of all-out effort, participant are required to maintain his or her cycling cadence at least 60 rpm or above. Intervention will end with a 5 minutes cool down at 50- 60% of HRmax. Total duration for each session will be 28 minutes. If a participant misses fewer than three sessions per week non- consecutively, the sessions missed will be replace at the end of period. However, if participants misses three or more sessions, he or she will be excluded from the study. Outcome measures will be assessed at baseline and at end of 6 weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIT for males | Experimental | Other: SIT |
| SIT for females | Experimental | Other: SIT |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI≧23kg/m2(WHO for Asia-Pacific region)
- No history of metabolic, hormonal, orthopedic, or cardiovascular diseases
- No current use of prescribed medication including oral contraception
Key exclusion criteria (2 listed)
- Contraindications to physical activity assessed by Physical Activity Readiness Questionnaire-PAR-Q
- Undergoes any surgical or hormone treatment
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 |
|---|---|---|
| SITSprint interval training of 4*4, with 30 seconds of all out workout followed by 4 minutes of active recovery for 4 cycles. | Other | SIT for females, SIT for males |
Primary outcome
BMI for change
Time frame: At baseline (before intervention begin) and post training (end of 6 weeks).
Waist Circumference for change
Time frame: At baseline (before intervention begin) and post training (end of 6 weeks).
Total Fat % for change
Time frame: At baseline (before intervention begin) and post training (end of 6 weeks).
Lean Muscle Mass for change
Time frame: At baseline (before intervention begin) and post training (end of 6 weeks).
skin Fold Measurement for change
Time frame: At baseline (before intervention begin) and post training (end of 6 weeks).
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 24 Nov 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.
Imtiyaz Ali Mir principal investigator
Universiti Tunku Abdul Rahman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIT in people with Overweight and Obesity, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
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 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 24 Nov 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 Malaysia. 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?
BMI for change (time frame: At baseline (before intervention begin) and post training (end of 6 weeks).). The study lists 5 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 24 Nov 2020.