OverweightNCT02781402
Relationship Between BMI & HRR After 4 Weeks of Aerobic Training
A study testing 4 weeks of Aerobic Training in people with Overweight, run by Universiti Tunku Abdul Rahman.
Trial summary
World Health Organization (WHO) defined body mass index (BMI) as the ratio of weight in kilograms to the square of the height in meters (kg/m2). BMI has been used widely to diagnose obesity as it is a simple method to be carried out and is also inexpensive. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- 4 weeks of Aerobic Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Nov 2016
- 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
- Sedentary subjects
- Age between 18 to 25 years old
- Body mass index range = 18.50 - 24.9 kg/m² (normal) = 25 - 29.9 kg/m² (overweight)
Who cannot join
- Subjects with cardiovascular disease
- Subjects with musculoskeletal problem
- Not willing to participate
About this study
Official title: Relationship Between Body Mass Index and Heart Rate Recovery Following 4 Weeks of Aerobic Training Among Young Physically Inactive Adults
World Health Organization (WHO) defined body mass index (BMI) as the ratio of weight in kilograms to the square of the height in meters (kg/m2). BMI has been used widely to diagnose obesity as it is a simple method to be carried out and is also inexpensive. According to WHO, there were 1.9 billion overweight individuals in 2014 with the age of 18 years old or above. Of 1.9 billion overweight individuals, there were 600 million obese adults. The prevalence of cardiovascular disease is higher among the overweight and obese individuals compared to individuals with normal body mass index. This probably is due to altered cardiovascular autonomic regulation. The risk of getting cardiovascular diseases is also higher among physically inactive individuals. As much as 60% of American adults are not regularly active and 25% of them are not active at all. Obese and overweight individuals tend to be physically inactive and it has been shown that there is a negative relationship between BMI and heart rate recovery (HRR). HRR is defined as difference in heart rate between maximum exercise and 1 minute later during recovery period after stopping of exercise. HRR after exercise stress is due to withdrawal of sympathetic nervous system and the reactivation of parasympathetic nervous system. Parasympathetic nervous system is altered in obese individuals therefore leading to poor HRR after exercise. Aerobic training not only can reduce the body composition but also improves the autonomic cardiovascular control. There is limited literature support for any study which shows that potential of 4 weeks aerobic training can influence the heart rate recovery in sedentary healthy adults. Most of studies conducted were using minimum of 6 to 8 weeks of aerobic training. The potential of 4 weeks of aerobic training in improving the autonomic nervous system among sedentary adults is still unclear. Therefore, we hypothesized in our study that there will be effect of 4 weeks of aerobic training on vagal modulation.
Read the detailed description
Obesity is a complex health issue that results from various causes and contributing factors. Individual factors like genetics and behavior may contribute to overweight and obesity. Genetics played an important role in increasing hunger and food intake of individuals. A few examples of common diseases that are related to obesity are type-2 diabetes, stroke, coronary heart disease and some types of cancer. All these obesity related diseases may not be fully reversible even after weight loss . Body mass index (BMI) is used widely as a screening tool to assess overweight and obesity. Based on the World Health Organization (WHO) international classification of BMI, individuals are considered as obese if their BMI value is equal to 30 kg/m2 or higher and overweight if BMI is 25-29.9 kg/m2. A study was conducted in USA to find the prevalence of obesity among children and adults. Researchers attempted to predict the childhood obesity and analyse the obesity trend among adults in United States. The results of the study showed that the prevalence of obesity among children were 16.9% and adults were 34.9%. There were no obvious changes in prevalence of obesity among children and adults in between 2003-2012 in United States (1). It cannot be denied that there is a link between increasing rate of obesity and increasing medical spending. Medical spending for obese individuals was 42% higher compared to those with normal body weight (2). The researchers reported in their study that obesity was one of the factors that became an economic burden for both public and private payers. South East Asia and Western Pacific countries suffer from diseases associated with obesity such as cardiovascular diseases and diabetes. Malaysia is the country the highest rate of obesity in South East Asia (3). Studies have showed that autonomic nervous system is associated with obesity. In 2001, a study was conducted to identify the effect of weight loss on autonomic nervous system. The findings showed that the activity of parasympathetic nervous system increased with weight loss and cardiac vagal tone improved significantly after weight loss (4). Cardiac vagal tone is controlled mainly by parasympathetic nervous system and this helps to improve the heart rate recovery (HRR). There are two phase of heart rate recovery, fast and slow phase. The fast phase is due to cardiac parasympathetic reactivation while the slow phase is because of cardiac sympathetic withdrawal. If there is any disturbance of the autonomic nervous system then the HRR will slow down (5). Therefore, HRR can be used to assess the cardiac autonomic function and as a marker of cardiac vagal tone. Abnormal heart rate recovery after exercise stress can be considered as dysfunction of autonomic nervous system. It has been suggested in several studies that heart rate recovery after exercise stress is slower among obese individuals compared to BMI individuals. A study was conducted to identify the relationship between heart rate recovery and body mass index. The finding showed that there was a negative association between heart rate recovery and body mass index. 3.5% of 2443 individuals presented with delayed decrease heart rate recovery. The prevalence of decreased heart rate recovery was higher among overweight and obese groups (6). In another study similar findings were observed. Researchers concluded that obese individuals are more likely to have an impaired heart rate recovery during the recovery phase after exercise (7). Aerobic training improves the autonomic cardiovascular control. A study on 4 weeks of aerobic training was done to identify its effects on cardiac vagal tone. Authors reported that 4 weeks of treadmill aerobic training was able to improve the autonomic nervous system among pre-hypertension individuals (8). The aerobic training consisted of 30 minutes treadmill exercise at 65% of maximum oxygen consumption. Another study showed the similar results in which the autonomic nervous system was improved after 6 months of moderate intensity aerobic training (9). The aerobic training was carried out 1 hour each session with 2 sessions in one week for 6 months. The present systematic review shows that aerobic training has been proven to be effective in increasing the heart rate recovery among subjects with established heart disease (10). The effects of 4 weeks of aerobic training in improving the cardiac vagal tone among sedentary healthy adults are still unclear. Therefore, we aim to study the effects of 4 weeks of aerobic training on vagal modulation.
- Conditions
- Overweight
- Being tested
- 4 weeks of Aerobic Training
- Keywords
- Overweight BMI Individuals, Normal BMI Individuals, Recovery Heart Rate
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 weeks of Aerobic TrainingProcedure or surgery
The duration of aerobic training was 40 minutes for each session and 3 days per week with the intensity of 75-80% of their maximum heart rate. The participants were needed to walk or jog on treadmill during the first 10 minutes at the intensity of 50-60% of maximal heart rate (HR max). The aerobic training was followed by 4 x 4 minutes intervals at 75-80% HR max. The participants were given 3 minutes active breaks in between the intervals in which they can either walk or jog at 50-60% of maximal heart rate.
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks of Aerobic Training for normal BMI group | Experimental | 4 weeks of aerobic training on treadmill 3 times per week. Receives: Procedure: 4 weeks of Aerobic Training |
| 4 weeks of Aerobic Training for overweight BMI group | Experimental | 4 weeks of aerobic training on treadmill 3 times per week. Receives: Procedure: 4 weeks of Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Recovery
The participants were required to take part in the exercise testing before beginning the 4 weeks of aerobic training. Ebbeling submaximal treadmill (EbbTM) protocol was used during the exercise testing. Finger pulse oximeter was placed on the participants' finger. The particiapnts were required to warm up for 4 minutes by walking at the speed that maintains the heart rate within 50% to 70% of their maximum heart rate (HR max) without any inclination (0% grade). Following 4 minutes of warm up, the participants walked at the same speed for another 4 minutes at a grade of 5%. After cessation of exercise test, heart rate was immediately recorded from the pulse oximeter for 1 minute. The heart rate was measured during the passive recovery phase in which the participants were in supine position.
Measured: At baseline and After 4 weeks of aerobic training
Secondary outcomes (1)
Change in Body Mass Index
BMI to be measure before and at end of 4 weeks of aerobic training to see any differences and impact of aerobic training on BMI.
Measured: At baseline and After 4 weeks of aerobic training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Model description
- Same intervention (4 weeks of aerobic training) was given to 2 different groups (Normal BMI group \& Overweight BMI group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 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
- NCT02781402
- Sponsor's protocol ID
- U/SERC/82/2015
- Status last verified
- Mar 2018
- First submitted
- 13 May 2016
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Confidentiality of participants.
Publications
Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.
PubMed 19635784Rissanen P, Franssila-Kallunki A, Rissanen A. Cardiac parasympathetic activity is increased by weight loss in healthy obese women. Obes Res. 2001 Oct;9(10):637-43. doi: 10.1038/oby.2001.84.
PubMed 11595781Brinkworth GD, Noakes M, Buckley JD, Clifton PM. Weight loss improves heart rate recovery in overweight and obese men with features of the metabolic syndrome. Am Heart J. 2006 Oct;152(4):693.e1-6. doi: 10.1016/j.ahj.2006.07.019.
PubMed 16996838Barbosa Lins TC, Valente LM, Sobral Filho DC, Barbosa e Silva O. Relation between heart rate recovery after exercise testing and body mass index. Rev Port Cardiol. 2015 Jan;34(1):27-33. doi: 10.1016/j.repc.2014.07.006. Epub 2015 Jan 8. English, Portuguese.
PubMed 25577658Gondoni LA, Titon AM, Nibbio F, Augello G, Caetani G, Liuzzi A. Heart rate behavior during an exercise stress test in obese patients. Nutr Metab Cardiovasc Dis. 2009 Mar;19(3):170-6. doi: 10.1016/j.numecd.2008.07.001. Epub 2008 Sep 19.
PubMed 18804987Collier SR, Kanaley JA, Carhart R Jr, Frechette V, Tobin MM, Bennett N, Luckenbaugh AN, Fernhall B. Cardiac autonomic function and baroreflex changes following 4 weeks of resistance versus aerobic training in individuals with pre-hypertension. Acta Physiol (Oxf). 2009 Mar;195(3):339-48. doi: 10.1111/j.1748-1716.2008.01897.x. Epub 2008 Sep 4.
PubMed 18774947Gulli G, Cevese A, Cappelletto P, Gasparini G, Schena F. Moderate aerobic training improves autonomic cardiovascular control in older women. Clin Auton Res. 2003 Jun;13(3):196-202. doi: 10.1007/s10286-003-0090-x.
PubMed 12822041Snoek JA, van Berkel S, van Meeteren N, Backx FJ, Daanen HA. Effect of aerobic training on heart rate recovery in patients with established heart disease; a systematic review. PLoS One. 2013 Dec 18;8(12):e83907. doi: 10.1371/journal.pone.0083907. eCollection 2013.
PubMed 24367618Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Body Mass Index and Heart Rate Recovery Following 4 Weeks of Aerobic Training Among Young Physically Inactive Adults
- ClinicalTrials.gov ID
- NCT02781402
- Acronym / sponsor ID
- U/SERC/82/2015
- Conditions
- Overweight
- Keywords
- Overweight BMI Individuals, Normal BMI Individuals, Recovery Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 24 May 2016 (estimated)
- 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.
World Health Organization (WHO) defined body mass index (BMI) as the ratio of weight in kilograms to the square of the height in meters (kg/m2). BMI has been used widely to diagnose obesity as it is a simple method to be carried out and is also inexpensive. According to WHO, there were 1.9 billion overweight individuals in 2014 with the age of 18 years old or above. Of 1.9 billion overweight individuals, there were 600 million obese adults. The prevalence of cardiovascular disease is higher among the overweight and obese individuals compared to individuals with normal body mass index. This probably is due to altered cardiovascular autonomic regulation. The risk of getting cardiovascular diseases is also higher among physically inactive individuals. As much as 60% of American adults are not regularly active and 25% of them are not active at all. Obese and overweight individuals tend to be physically inactive and it has been shown that there is a negative relationship between BMI and heart rate recovery (HRR). HRR is defined as difference in heart rate between maximum exercise and 1 minute later during recovery period after stopping of exercise. HRR after exercise stress is due to withdrawal of sympathetic nervous system and the reactivation of parasympathetic nervous system. Parasympathetic nervous system is altered in obese individuals therefore leading to poor HRR after exercise. Aerobic training not only can reduce the body composition but also improves the autonomic cardiovascular control. There is limited literature support for any study which shows that potential of 4 weeks aerobic training can influence the heart rate recovery in sedentary healthy adults. Most of studies conducted were using minimum of 6 to 8 weeks of aerobic training. The potential of 4 weeks of aerobic training in improving the autonomic nervous system among sedentary adults is still unclear. Therefore, we hypothesized in our study that there will be effect of 4 weeks of aerobic training on vagal modulation.
Detailed description
Obesity is a complex health issue that results from various causes and contributing factors. Individual factors like genetics and behavior may contribute to overweight and obesity. Genetics played an important role in increasing hunger and food intake of individuals. A few examples of common diseases that are related to obesity are type-2 diabetes, stroke, coronary heart disease and some types of cancer. All these obesity related diseases may not be fully reversible even after weight loss . Body mass index (BMI) is used widely as a screening tool to assess overweight and obesity. Based on the World Health Organization (WHO) international classification of BMI, individuals are considered as obese if their BMI value is equal to 30 kg/m2 or higher and overweight if BMI is 25-29.9 kg/m2. A study was conducted in USA to find the prevalence of obesity among children and adults. Researchers attempted to predict the childhood obesity and analyse the obesity trend among adults in United States. The results of the study showed that the prevalence of obesity among children were 16.9% and adults were 34.9%. There were no obvious changes in prevalence of obesity among children and adults in between 2003-2012 in United States (1). It cannot be denied that there is a link between increasing rate of obesity and increasing medical spending. Medical spending for obese individuals was 42% higher compared to those with normal body weight (2). The researchers reported in their study that obesity was one of the factors that became an economic burden for both public and private payers. South East Asia and Western Pacific countries suffer from diseases associated with obesity such as cardiovascular diseases and diabetes. Malaysia is the country the highest rate of obesity in South East Asia (3). Studies have showed that autonomic nervous system is associated with obesity. In 2001, a study was conducted to identify the effect of weight loss on autonomic nervous system. The findings showed that the activity of parasympathetic nervous system increased with weight loss and cardiac vagal tone improved significantly after weight loss (4). Cardiac vagal tone is controlled mainly by parasympathetic nervous system and this helps to improve the heart rate recovery (HRR). There are two phase of heart rate recovery, fast and slow phase. The fast phase is due to cardiac parasympathetic reactivation while the slow phase is because of cardiac sympathetic withdrawal. If there is any disturbance of the autonomic nervous system then the HRR will slow down (5). Therefore, HRR can be used to assess the cardiac autonomic function and as a marker of cardiac vagal tone. Abnormal heart rate recovery after exercise stress can be considered as dysfunction of autonomic nervous system. It has been suggested in several studies that heart rate recovery after exercise stress is slower among obese individuals compared to BMI individuals. A study was conducted to identify the relationship between heart rate recovery and body mass index. The finding showed that there was a negative association between heart rate recovery and body mass index. 3.5% of 2443 individuals presented with delayed decrease heart rate recovery. The prevalence of decreased heart rate recovery was higher among overweight and obese groups (6). In another study similar findings were observed. Researchers concluded that obese individuals are more likely to have an impaired heart rate recovery during the recovery phase after exercise (7). Aerobic training improves the autonomic cardiovascular control. A study on 4 weeks of aerobic training was done to identify its effects on cardiac vagal tone. Authors reported that 4 weeks of treadmill aerobic training was able to improve the autonomic nervous system among pre-hypertension individuals (8). The aerobic training consisted of 30 minutes treadmill exercise at 65% of maximum oxygen consumption. Another study showed the similar results in which the autonomic nervous system was improved after 6 months of moderate intensity aerobic training (9). The aerobic training was carried out 1 hour each session with 2 sessions in one week for 6 months. The present systematic review shows that aerobic training has been proven to be effective in increasing the heart rate recovery among subjects with established heart disease (10). The effects of 4 weeks of aerobic training in improving the cardiac vagal tone among sedentary healthy adults are still unclear. Therefore, we aim to study the effects of 4 weeks of aerobic training on vagal modulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Same intervention (4 weeks of aerobic training) was given to 2 different groups (Normal BMI group \& Overweight BMI group).
| Arm | Type | Receives |
|---|---|---|
| 4 weeks of Aerobic Training for normal BMI group | Experimental | Procedure: 4 weeks of Aerobic Training4 weeks of aerobic training on treadmill 3 times per week. |
| 4 weeks of Aerobic Training for overweight BMI group | Experimental | Procedure: 4 weeks of Aerobic Training4 weeks of aerobic training on treadmill 3 times per week. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary subjects
- Age between 18 to 25 years old
- Body mass index range = 18.50 - 24.9 kg/m² (normal) = 25 - 29.9 kg/m² (overweight)
Key exclusion criteria (3 listed)
- Subjects with cardiovascular disease
- Subjects with musculoskeletal problem
- Not willing to participate
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 |
|---|---|---|
| 4 weeks of Aerobic TrainingThe duration of aerobic training was 40 minutes for each session and 3 days per week with the intensity of 75-80% of their maximum heart rate. The participants were needed to walk or jog on treadmill during the first 10 minutes at the intensity of 50-60% of maximal heart rate (HR max). The aerobic training was followed by 4 x 4 minutes intervals at 75-80% HR max. The participants were given 3 minutes active breaks in between the intervals in which they can either walk or jog at 50-60% of maximal heart rate. | Procedure or surgery | 4 weeks of Aerobic Training for normal BMI group, 4 weeks of Aerobic Training for overweight BMI group |
Primary outcome
Change in Heart Rate Recovery
Time frame: At baseline and After 4 weeks of aerobic training
The participants were required to take part in the exercise testing before beginning the 4 weeks of aerobic training. Ebbeling submaximal treadmill (EbbTM) protocol was used during the exercise testing. Finger pulse oximeter was placed on the participants' finger. The particiapnts were required to warm up for 4 minutes by walking at the speed that maintains the heart rate within 50% to 70% of their maximum heart rate (HR max) without any inclination (0% grade). Following 4 minutes of warm up, the participants walked at the same speed for another 4 minutes at a grade of 5%. After cessation of exercise test, heart rate was immediately recorded from the pulse oximeter for 1 minute. The heart rate was measured during the passive recovery phase in which the participants were in supine position.
1 secondary outcome
Change in Body Mass Index
Time frame: At baseline and After 4 weeks of aerobic training
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 23 Mar 2018.
- Background: PubMed 19635784Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.
- Background: PubMed 11595781Rissanen P, Franssila-Kallunki A, Rissanen A. Cardiac parasympathetic activity is increased by weight loss in healthy obese women. Obes Res. 2001 Oct;9(10):637-43. doi: 10.1038/oby.2001.84.
- Background: PubMed 16996838Brinkworth GD, Noakes M, Buckley JD, Clifton PM. Weight loss improves heart rate recovery in overweight and obese men with features of the metabolic syndrome. Am Heart J. 2006 Oct;152(4):693.e1-6. doi: 10.1016/j.ahj.2006.07.019.
- Background: PubMed 25577658Barbosa Lins TC, Valente LM, Sobral Filho DC, Barbosa e Silva O. Relation between heart rate recovery after exercise testing and body mass index. Rev Port Cardiol. 2015 Jan;34(1):27-33. doi: 10.1016/j.repc.2014.07.006. Epub 2015 Jan 8. English, Portuguese.
- Background: PubMed 18804987Gondoni LA, Titon AM, Nibbio F, Augello G, Caetani G, Liuzzi A. Heart rate behavior during an exercise stress test in obese patients. Nutr Metab Cardiovasc Dis. 2009 Mar;19(3):170-6. doi: 10.1016/j.numecd.2008.07.001. Epub 2008 Sep 19.
- Background: PubMed 18774947Collier SR, Kanaley JA, Carhart R Jr, Frechette V, Tobin MM, Bennett N, Luckenbaugh AN, Fernhall B. Cardiac autonomic function and baroreflex changes following 4 weeks of resistance versus aerobic training in individuals with pre-hypertension. Acta Physiol (Oxf). 2009 Mar;195(3):339-48. doi: 10.1111/j.1748-1716.2008.01897.x. Epub 2008 Sep 4.
- Background: PubMed 12822041Gulli G, Cevese A, Cappelletto P, Gasparini G, Schena F. Moderate aerobic training improves autonomic cardiovascular control in older women. Clin Auton Res. 2003 Jun;13(3):196-202. doi: 10.1007/s10286-003-0090-x.
- Background: PubMed 24367618Snoek JA, van Berkel S, van Meeteren N, Backx FJ, Daanen HA. Effect of aerobic training on heart rate recovery in patients with established heart disease; a systematic review. PLoS One. 2013 Dec 18;8(12):e83907. doi: 10.1371/journal.pone.0083907. eCollection 2013.
- Results publication: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Individual participant dataSharing planned: No. Confidentiality of participants.
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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
Questions about this trial
What is this clinical trial studying?
A study testing 4 weeks of Aerobic Training in people with Overweight, run by Universiti Tunku Abdul Rahman.
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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Heart Rate Recovery (time frame: At baseline and After 4 weeks of aerobic training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781402, which also lists 9 linked publications.
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 23 Mar 2018.