Relationship Between BMI & HRR After 4 Weeks of Aerobic Training
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
4 weeks of Aerobic Training
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight BMI Individuals, Normal BMI Individuals, Recovery Heart Rate
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Subjects with cardiovascular disease
- Subjects with musculoskeletal problem
- Not willing to participate
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
4 weeks of Aerobic Training for normal BMI group
4 weeks of Aerobic Training for overweight BMI group
Arm Description
4 weeks of aerobic training on treadmill 3 times per week.
4 weeks of aerobic training on treadmill 3 times per week.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02781402
First Posted
May 13, 2016
Last Updated
March 21, 2018
Sponsor
Universiti Tunku Abdul Rahman
1. Study Identification
Unique Protocol Identification Number
NCT02781402
Brief Title
Relationship Between BMI & HRR After 4 Weeks of Aerobic Training
Official Title
Relationship Between Body Mass Index and Heart Rate Recovery Following 4 Weeks of Aerobic Training Among Young Physically Inactive Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Overweight BMI Individuals, Normal BMI Individuals, Recovery Heart Rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Same intervention (4 weeks of aerobic training) was given to 2 different groups (Normal BMI group & Overweight BMI group).
Masking
Outcomes Assessor
Masking Description
Assessor who measured pre and post outcomes was blended and did not know participants belonged to which group.
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4 weeks of Aerobic Training for normal BMI group
Arm Type
Experimental
Arm Description
4 weeks of aerobic training on treadmill 3 times per week.
Arm Title
4 weeks of Aerobic Training for overweight BMI group
Arm Type
Experimental
Arm Description
4 weeks of aerobic training on treadmill 3 times per week.
Intervention Type
Procedure
Intervention Name(s)
4 weeks of Aerobic Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Heart Rate Recovery
Description
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.
Time Frame
At baseline and After 4 weeks of aerobic training
Secondary Outcome Measure Information:
Title
Change in Body Mass Index
Description
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.
Time Frame
At baseline and After 4 weeks of aerobic training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Subjects with cardiovascular disease
Subjects with musculoskeletal problem
Not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imtiyaz Ali Mir
Organizational Affiliation
Universiti Tunku Abdul Rahman
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Confidentiality of participants.
Citations:
PubMed Identifier
19635784
Citation
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.
Results Reference
background
PubMed Identifier
11595781
Citation
Rissanen 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.
Results Reference
background
PubMed Identifier
16996838
Citation
Brinkworth 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.
Results Reference
background
PubMed Identifier
25577658
Citation
Barbosa 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.
Results Reference
background
PubMed Identifier
18804987
Citation
Gondoni 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.
Results Reference
background
PubMed Identifier
18774947
Citation
Collier 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.
Results Reference
background
PubMed Identifier
12822041
Citation
Gulli 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.
Results Reference
background
PubMed Identifier
24367618
Citation
Snoek 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 Reference
background
PubMed Identifier
24570244
Citation
Ogden 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.
Results Reference
result
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Relationship Between BMI & HRR After 4 Weeks of Aerobic Training
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