Relationship Between BMI & HRR After 4 Weeks of Aerobic Training

March 21, 2018 updated by: Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Sedentary subjects
  2. Age between 18 to 25 years old
  3. Body mass index range = 18.50 - 24.9 kg/m² (normal) = 25 - 29.9 kg/m² (overweight)

Exclusion Criteria:

  1. Subjects with cardiovascular disease
  2. Subjects with musculoskeletal problem
  3. Not willing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 4 weeks of Aerobic Training for normal BMI group
4 weeks of aerobic training on treadmill 3 times per week.
Procedure: 4 weeks of Aerobic Training
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.
Experimental: 4 weeks of Aerobic Training for overweight BMI group
4 weeks of aerobic training on treadmill 3 times per week.
Procedure: 4 weeks of Aerobic Training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and After 4 weeks of aerobic training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index
Time Frame: At baseline and After 4 weeks of aerobic training
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.
At baseline and After 4 weeks of aerobic training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Tunku Abdul Rahman

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U/SERC/82/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidentiality of participants.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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