NCT02781402

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

May 13, 2016

Last Update Submit

March 21, 2018

Conditions

Keywords

Overweight BMI IndividualsNormal BMI IndividualsRecovery Heart Rate

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline and After 4 weeks of aerobic training

Secondary Outcomes (1)

  • Change in Body Mass Index

    At baseline and After 4 weeks of aerobic training

Study Arms (2)

4 weeks of Aerobic Training for normal BMI group

EXPERIMENTAL

4 weeks of aerobic training on treadmill 3 times per week.

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.

Procedure: 4 weeks of Aerobic Training

Interventions

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.

4 weeks of Aerobic Training for normal BMI group4 weeks of Aerobic Training for overweight BMI group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Subjects with cardiovascular disease
  • Subjects with musculoskeletal problem
  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 19635784BACKGROUND
  • 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.

    PMID: 11595781BACKGROUND
  • 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.

    PMID: 16996838BACKGROUND
  • 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.

    PMID: 25577658BACKGROUND
  • 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.

    PMID: 18804987BACKGROUND
  • 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.

    PMID: 18774947BACKGROUND
  • 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.

    PMID: 12822041BACKGROUND
  • 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.

    PMID: 24367618BACKGROUND
  • 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.

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Imtiyaz Ali Mir

    Universiti Tunku Abdul Rahman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor who measured pre and post outcomes was blended and did not know participants belonged to which group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Same intervention (4 weeks of aerobic training) was given to 2 different groups (Normal BMI group \& Overweight BMI group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 24, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

March 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Confidentiality of participants.