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Physical ActivityNCT00995579

Assessment of Energy Expenditure by Indirect Calorimetry for a Daily 10,000 Steps Goal

An observational study of Physical Activity and Energy Expenditure, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to measure the actual energy expenditure (EE) using indirect calorimetry for the 10,000 steps goal, and compared to the estimated EE using predictive equation. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity, Energy Expenditure
How many people
20 participants
Where
1 siteTaiwan
Study dates
Nov 2008to Feb 2009
Phase
Observational
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 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Healthy college volunteers

Who may be able to join

  • Aged 18-30 y/o

Who cannot join

  • Unstable systemic disease, respiratory diseases, cardiac diseases or other clinical diagnosis which would affect outcome measure
  • Subjects who answered yes to any of the PAR-Q questions or who were not physically able to complete the test

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • School and Graduate Institute of Physical Therapy, National Taiwan University

    Taipei

Other trials in Taiwan

About this study

The purpose of this study was to measure the actual energy expenditure (EE) using indirect calorimetry for the 10,000 steps goal, and compared to the estimated EE using predictive equation.

Read the detailed description

Physical inactivity is considered a major risk factor for a number of adverse health outcomes such as obesity, hypertension, cardiovascular disease, diabetes mellitus, and all-cause mortality. Certain guidelines specifically recommend taking 10,000 steps per day for a goal. Some of pedometers have a function of energy expenditure estimation in addition to counting steps. However, the EE derived from pedometers is the indirect estimation calculated from metabolic calculations instead of direct measurement.The purpose of this study was to measure the actual energy expenditure (EE) using indirect calorimetry for the 10,000 steps goal, and compared to the estimated EE using predictive equation.

Twenty healthy college volunteers were recruited. First, height and weight were measured from each subject. Body mass index (BMI) was calculated as the ratio of weight to height in meters squared. We used BioScan 920 to get all subjects' body composition data including fat mass and fat-free mass. Followed by measurements of basic characteristics, all subjects wore the pedometer and walked 10,000 steps on the treadmill. The walking speeds ranged from 3.0 to 4.0 miles per hour (mph) according to different gender. The speed of 4.0 mph was set for male and 3.0 mph was set for female. If the subject could'nt follow the pre-set speed, he/she could walk with self-comfortable speed but the speed should be in the range of 3.0 to 4.0 mph defined as moderate intensity of ACSM's recommendation. Subjects rested on the chair with back support for 3 minutes and then completed the 10,000 steps goal. After recovery for 3 minutes, the data collection was finished. The stopping criteria of the test were as follows: dizziness, nausea, dyspnea, or leg fatigue which leads subjects unable to continue. Expired gas was collected using the Cosmed K4b2 portable indirect calorimetry system, and EE was monitored breath-by-breath according to the following formula:

EE (Kcal/min)= 3.781×VO2+1.237×VCO2

where VO2 represents the standardized oxygen consumption per minute, and VCO2 is the carbon dioxide production per minute. Estimated EE was calculated by the predictive equation published by ACSM:

VO2 (ml/kg/min)= 0.1×S (m/min)+1.8×S×G (%)+3.5

where S represents the walking speed, and G is the walking grade.

The total walking duration and distance for taking 10,000 steps were also recorded. Pulmonary function tests were performed on the other day to get each subject's functional vital capacity (FVC). We used this parameter to estimate subject's predicted maximal minute ventilation (predicted max VE) according to the equation provided in the guidelines of American Thoracic Society (ATS) for cardiopulmonary exercise testing:

VE (L/min)= 26.3×VC-34

where VC represents vital capacity. The ratio of averaged VE during walking and predicted maximal VE was calculated to determine the level of exercise intensity for taking 10,000 steps.

Keywords
Physical Activity, Energy Expenditure
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00995579
Study groupRoleWhat they receive
Healthy college volunteersNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. energy expenditure

    Measured: 3 months

Secondary outcomes (2)
  1. Body composition: fat mass and fat-free mass

    Measured: 3 months

  2. Pulmonary function: FVC, FEV1, FEV1/FVC

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00995579
Sponsor's protocol ID
200809081R
Status last verified
Oct 2009
First submitted
13 Oct 2009
Last updated
15 Oct 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Activity and Energy Expenditure, run by National Taiwan University Hospital at 1 site in Taiwan.

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 1 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 15 Oct 2009. 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 Taiwan. 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?

energy expenditure (time frame: 3 months). 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 15 Oct 2009.

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