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.
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
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.
- Conditions
- Physical Activity, Energy Expenditure
- 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 group | Role | What they receive |
|---|---|---|
| Healthy college volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy expenditure
Measured: 3 months
Secondary outcomes (2)
Body composition: fat mass and fat-free mass
Measured: 3 months
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.
- First posted15 Oct 2009 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Liying Wang, Ph.D., Principal investigator, chool and Graduate Institute of Physical Therapy, National Taiwan University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Energy Expenditure by Indirect Calorimetry for a Daily 10,000 Steps Goal
- ClinicalTrials.gov ID
- NCT00995579
- Acronym / sponsor ID
- 200809081R
- Conditions
- Physical Activity, Energy Expenditure
- Keywords
- Physical Activity, Energy Expenditure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 Oct 2009 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy college volunteers | – | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy college volunteers
Key inclusion criteria (1 listed)
- Aged 18-30 y/o
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
energy expenditure
Time frame: 3 months
2 secondary outcomes
Body composition: fat mass and fat-free mass
Time frame: 3 months
Pulmonary function: FVC, FEV1, FEV1/FVC
Time frame: 3 months
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 15 Oct 2009.
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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.
Liying Wang, Ph.D. principal investigator
chool and Graduate Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
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.