Body Temperature ChangesNCT02310334
The Pacing (Guided Vs Unguided) Strategies Study
A study testing Guided Exercise Session and Unguided Exercise Session in people with Body Temperature Changes, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
The objectives of this study are to demonstrate that real time physiological status monitoring and the use of optimization techniques during exercise can have a positive impact on physiological status, and to collect metabolic flexibility profiles of young fit adults during rest and exercise. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Changes
- What is being tested?
- Guided Exercise Session and Unguided Exercise Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2015
- Phase
- Interventional
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and Female
- Ages 18 to 29 at the beginning of the study
- Relatively fit can run 2 miles in under 16 minutes
Who cannot join
- History of Skin Sensitivity to Nickel
- Hypertension
- Alcoholism
- Diabetes
- Pregnant
- Age >29
Show all 28Show fewer
- Cannot run 2 miles in less than 16 minutes
- No regular weekly exercise
- Difficulty Swallowing Food or Large Pills
- Diverticulitis
- Inflammatory Bowel Disease
- Peptic Ulcer Disease
- Crohn's Disease
- Ulcerative Colitis
- Previous Gastrointestinal Surgery
- Possible Nuclear Magnetic Resonance Scan
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- History or presence of kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes
- History of bariatric or certain other surgeries related to weight control
- Smokers or other tobacco users (for at least 6 months prior to the start of the study)
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
- Unable or unwilling to give informed consent or communicate with study staff.
- Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
- Blood donation within the previous month
Trial locations and contacts
1 site in 1 country.
United States1 site
Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Official title: The Impact of Real-Time Physiological Status Based Pacing Guidance on Physiological Strain for Exercising Humans
The objectives of this study are to demonstrate that real time physiological status monitoring and the use of optimization techniques during exercise can have a positive impact on physiological status, and to collect metabolic flexibility profiles of young fit adults during rest and exercise.
Read the detailed description
This experiment aims to accomplish two goals: collect additional metabolic flexibility data with young fit adults in response to exercise; and demonstrate that automated pace guidance generated from real-time thermal-work strain monitoring and an optimized pacing policy will allow less stressful completion of a timed (60 minute) treadmill exercise of 5 miles. Each participant will undergo two treatments of first UNGUIDED followed by GUIDED exercise. The two exercise sessions will be conducted as part of a ~24 hour stay in an indirect calorimetry chamber.
- Conditions
- Body Temperature Changes
- Being tested
- Guided Exercise Session, Unguided Exercise Session
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Exercise SessionOther
Participants will be provided a pace based upon their current (estimated) physiological strain index (PSI) - a measure of thermal work strain, the time, and the distance completed already.
Unguided Exercise SessionOther
Participants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible.
| Study group | Role | What they receive |
|---|---|---|
| Unguided Pacing Strategy | Experimental | Each participant will stay in the calorimeter (~24 hrs) on 2 different occasions. During the first visit, the participant will partake in an unguided exercise session. Receives: Other: Guided Exercise Session |
| Guided Pacing Strategy | Experimental | Each participant will stay in the calorimeter (~24 hrs) on 2 different occasions. During the second visit, the participant will partake in a guided exercise session. Receives: Other: Unguided Exercise Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Strain Index (PSI)
The PSI is an index that combines heart rate and core body temperatures with equal weights into an index from 0 to 10+. PSI will be calculated according to Moran et al. (1998) from measures of heart rate and core body temperature.
Measured: During 2-hour exercise session
Secondary outcomes (8)
Metabolic Flexibility
O2 utilization and CO2 production will be analyzed during each calorimeter stay and used to measure metabolic rate indirectly.
Measured: 24 hours
Continuous Glucose Monitoring
Continuous glucose monitoring will be used to examine the effects of the exercise regime on blood glucose.
Measured: 24 hours
Self Perception Scales
Self perception scales will be used that measure mood state, perceived exertion, thermal sensation, physical stresses and motivation.
Measured: During 2-hour exercise session
Profile of Mood States (POMS) Questionnaire
The POMS is an inventory of subjective mood states (McNair, Lorr and Droppleman, 1992).
Measured: During 2-hour exercise session
Thermal Sensation Scale
Two thermal sensation scales (original and modified) will be used to assess the thermal sensation of volunteers.
Measured: During 2-hour exercise session
Perceived Exertion Scale
The Borg (1970) rating of perceived exertion (RPE) will be used.
Measured: During 2-hour exercise session
Feeling Scale
The feeling scale will be used as an affective valence measure of exercise.
Measured: During 2-hour exercise session
Motivation
Question will be asked to assess motivation during each exercise session.
Measured: During 2-hour exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- United States Army Research Institute of Environmental Medicine
- Responsible party
- Principal investigator, William Rumpler, USDA Beltsville Human Nutrition Research Center
- Investigators
- William V Rumpler, PhD, Principal investigator, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310334
- Sponsor's protocol ID
- HS47
- Status last verified
- Feb 2016
- First submitted
- 1 Dec 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Real-Time Physiological Status Based Pacing Guidance on Physiological Strain for Exercising Humans
- ClinicalTrials.gov ID
- NCT02310334
- Acronym / sponsor ID
- HS47
- Conditions
- Body Temperature Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Collaborators
- United States Army Research Institute of Environmental Medicine
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Dec 2014 (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 objectives of this study are to demonstrate that real time physiological status monitoring and the use of optimization techniques during exercise can have a positive impact on physiological status, and to collect metabolic flexibility profiles of young fit adults during rest and exercise.
Detailed description
This experiment aims to accomplish two goals: collect additional metabolic flexibility data with young fit adults in response to exercise; and demonstrate that automated pace guidance generated from real-time thermal-work strain monitoring and an optimized pacing policy will allow less stressful completion of a timed (60 minute) treadmill exercise of 5 miles. Each participant will undergo two treatments of first UNGUIDED followed by GUIDED exercise. The two exercise sessions will be conducted as part of a ~24 hour stay in an indirect calorimetry chamber.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unguided Pacing Strategy | Experimental | Other: Guided Exercise SessionEach participant will stay in the calorimeter (~24 hrs) on 2 different occasions. During the first visit, the participant will partake in an unguided exercise session. |
| Guided Pacing Strategy | Experimental | Other: Unguided Exercise SessionEach participant will stay in the calorimeter (~24 hrs) on 2 different occasions. During the second visit, the participant will partake in a guided exercise session. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and Female
- Ages 18 to 29 at the beginning of the study
- Relatively fit can run 2 miles in under 16 minutes
Key exclusion criteria (28 listed)
- History of Skin Sensitivity to Nickel
- Hypertension
- Alcoholism
- Diabetes
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Exercise SessionParticipants will be provided a pace based upon their current (estimated) physiological strain index (PSI) - a measure of thermal work strain, the time, and the distance completed already. | Other | Unguided Pacing Strategy |
| Unguided Exercise SessionParticipants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible. | Other | Guided Pacing Strategy |
Primary outcome
Physiological Strain Index (PSI)
Time frame: During 2-hour exercise session
The PSI is an index that combines heart rate and core body temperatures with equal weights into an index from 0 to 10+. PSI will be calculated according to Moran et al. (1998) from measures of heart rate and core body temperature.
8 secondary outcomes
Metabolic Flexibility
Time frame: 24 hours
Continuous Glucose Monitoring
Time frame: 24 hours
Self Perception Scales
Time frame: During 2-hour exercise session
Profile of Mood States (POMS) Questionnaire
Time frame: During 2-hour exercise session
Thermal Sensation Scale
Time frame: During 2-hour exercise session
Perceived Exertion Scale
Time frame: During 2-hour exercise session
Feeling Scale
Time frame: During 2-hour exercise session
Motivation
Time frame: During 2-hour exercise session
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 24 Feb 2016.
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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.
William V Rumpler, PhD principal investigator
USDA Beltsville Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Exercise Session and Unguided Exercise Session in people with Body Temperature Changes, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
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 3 inclusion and 28 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 24 Feb 2016. 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 United States. 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?
Physiological Strain Index (PSI) (time frame: During 2-hour exercise session). 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 24 Feb 2016.