HealthyNCT02475473
Circulatory Levels of Irisin in Response to Chronic Resistance Training
A study testing Exercise Training in people with Healthy, run by Texas Tech University at 1 site in United States.
Trial summary
Study the responses of circulatory irisin to chronic high-intensity resistance training Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Oct 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
- Pregnant females.
- Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
- Individuals found to be less than 110 pounds.
- Participants that exercise more than three times per week or strength train more than twice per week.
- Individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded.
Show all 10Show fewer
- Cigarette smoking (current or those who quit within the previous 6 months
- Hypertension
- Overweight and obese
- Pre-diabetics
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Sport Sciences Building
Lubbock, Texas, 79423
About this study
Study the responses of circulatory irisin to chronic high-intensity resistance training
Read the detailed description
Objective: The purpose of this study is to study the circulating levels of irisin in response to chronic high-intensity resistance training in a group of healthy young adults.
Sample: The sample will be comprised 44 of adult men and women unpaid volunteers between the ages of 18 and 30.
Pre-screening assessments:
Informed consent, PAR-Q, Medical History and Exercise History will be used to determine health status and prior exercise experience. Menstrual cycle log will be required for female participants.
Pre-Intervention assessments:
- Anthropometric measurements and Body Composition: Height, triceps, thigh and calf skinfolds, biceps, thigh, hip, waist, and calf circumferences will be measured. Dual-energy x-ray absorptiometry (DEXA) will be performed to obtain body composition.
- Cardiopulmonary and Strength Fitness Testing. Cardiopulmonary fitness will be determined via maximum oxygen uptake testing. One maximum repetition (1-RM) will be used to assess the muscular fitness.
- Spontaneous Physical Activity: Daily activity level for 7 days will be collected.
- Familiarization. Participant will be instructed on the muscle conditioning techniques used for strength training so that the techniques can be mastered. The rate of perceived exertion (RPE) scale will also be used for familiarization during these sessions.
Intervention: The intervention will last 3 weeks with a frequency of 3 training session per week. We will collect blood samples levels at session 1 (at the beginning of week 1), session 3 (at the end of week 1), at session 6 (at the end of week 2) and session 9 (at the end of week 3). Blood draws will occur at the beginning of each session evaluated (pre-session), at the 45 min mark during each session and immediately after each session (post-session).
The sessions will consist on a circuit training of 3 sets of 7 exercises focused on major muscle groups. Ten repetitions on each circuit at 70% of the maximum capacity will be performed.
During the intervention:
- Blood-related variables. Baseline glucose, lactate and hematocrit will be obtained from all participants prior to intervention. Lactate and Hematocrit will be obtained pre-intervention and post-intervention, and within 1 min post workout at sessions 1, 3, 6 and 9.
Irisin will be obtained from blood samples at baseline, during and after training sessions 1, 3, 6 and 9. Irisin will be measured via a commercial enzyme-linked immunosorbent assay.
- Dietary Controls. Each participant will complete the Food Preference Questionnaire. In addition, the Automated Self-Administered 24-hour Recall (ASA24) will be collected for the days prior to sessions 1, 3, 6 and 9.
Post-Intervention assessments:
- Anthropometric measurements and Body Composition: Height, triceps, thigh and calf skinfolds, biceps, thigh, hip, waist, and calf circumferences will be measured. Dual-energy x-ray absorptiometry (DEXA) will be performed to obtain body composition.
- Caridorespiratory capacity determined via maximum oxygen uptake testing. One maximum repetition (1-RM) will be used to assess the muscular fitness.
- Spontaneous Physical Activity: Daily activity level for 7 days will be collected.
- Conditions
- Healthy
- Being tested
- Exercise Training
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
Chronic High-Intensity Resistance Training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The acute intervention will consist of 1 session of training following the program:
Resistance Training Exercises. Each participant in the intervention group will perform resistance-training exercises in the form of a circuit. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Initial intensity 6-7 of RPE and ending the set at 9-10. Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. Receives: Other: Exercise Training |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum irisin levels
Measured: Baseline and 3 weeks
Blood Lactate levels
Intensity of exercise on sessions 1, 3, 6 and 9
Measured: 3 weeks
Changes in physical fitness levels as meassured by 1RM (repetition maximum) and Cardio-respiratory maximal testing
Measured: Baseline and 3 weeks
Changes in Body composition assessment: DEXA and anthropometry
Measured: Baseline and 3 weeks
Changes in Blood glucose levels
Measured: Baseline and 3 weeks
Changes in Hematocrit concentration
Measured: Baseline and 3 weeks
Diet assessment: 24 hour recall and Food Preference Questionnaire
Measured: 3 weeks
Physical Activity assessment: accelerometry
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Fernandez del Valle, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475473
- Sponsor's protocol ID
- 504792B
- Status last verified
- Sep 2015
- First submitted
- 3 Feb 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulatory Levels of Irisin in Response to Chronic Resistance Training
- ClinicalTrials.gov ID
- NCT02475473
- Acronym / sponsor ID
- 504792B
- Conditions
- Healthy
- Keywords
- Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- First posted
- 18 Jun 2015 (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.
Study the responses of circulatory irisin to chronic high-intensity resistance training
Detailed description
Objective: The purpose of this study is to study the circulating levels of irisin in response to chronic high-intensity resistance training in a group of healthy young adults.
Sample: The sample will be comprised 44 of adult men and women unpaid volunteers between the ages of 18 and 30.
Pre-screening assessments:
Informed consent, PAR-Q, Medical History and Exercise History will be used to determine health status and prior exercise experience. Menstrual cycle log will be required for female participants.
Pre-Intervention assessments:
- Anthropometric measurements and Body Composition: Height, triceps, thigh and calf skinfolds, biceps, thigh, hip, waist, and calf circumferences will be measured. Dual-energy x-ray absorptiometry (DEXA) will be performed to obtain body composition.
- Cardiopulmonary and Strength Fitness Testing. Cardiopulmonary fitness will be determined via maximum oxygen uptake testing. One maximum repetition (1-RM) will be used to assess the muscular fitness.
- Spontaneous Physical Activity: Daily activity level for 7 days will be collected.
- Familiarization. Participant will be instructed on the muscle conditioning techniques used for strength training so that the techniques can be mastered. The rate of perceived exertion (RPE) scale will also be used for familiarization during these sessions.
Intervention: The intervention will last 3 weeks with a frequency of 3 training session per week. We will collect blood samples levels at session 1 (at the beginning of week 1), session 3 (at the end of week 1), at session 6 (at the end of week 2) and session 9 (at the end of week 3). Blood draws will occur at the beginning of each session evaluated (pre-session), at the 45 min mark during each session and immediately after each session (post-session).
The sessions will consist on a circuit training of 3 sets of 7 exercises focused on major muscle groups. Ten repetitions on each circuit at 70% of the maximum capacity will be performed.
During the intervention:
- Blood-related variables. Baseline glucose, lactate and hematocrit will be obtained from all participants prior to intervention. Lactate and Hematocrit will be obtained pre-intervention and post-intervention, and within 1 min post workout at sessions 1, 3, 6 and 9.
Irisin will be obtained from blood samples at baseline, during and after training sessions 1, 3, 6 and 9. Irisin will be measured via a commercial enzyme-linked immunosorbent assay.
- Dietary Controls. Each participant will complete the Food Preference Questionnaire. In addition, the Automated Self-Administered 24-hour Recall (ASA24) will be collected for the days prior to sessions 1, 3, 6 and 9.
Post-Intervention assessments:
- Anthropometric measurements and Body Composition: Height, triceps, thigh and calf skinfolds, biceps, thigh, hip, waist, and calf circumferences will be measured. Dual-energy x-ray absorptiometry (DEXA) will be performed to obtain body composition.
- Caridorespiratory capacity determined via maximum oxygen uptake testing. One maximum repetition (1-RM) will be used to assess the muscular fitness.
- Spontaneous Physical Activity: Daily activity level for 7 days will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise TrainingThe acute intervention will consist of 1 session of training following the program: Resistance Training Exercises. Each participant in the intervention group will perform resistance-training exercises in the form of a circuit. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Initial intensity 6-7 of RPE and ending the set at 9-10. Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
- Pregnant females.
- Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
- Individuals found to be less than 110 pounds.
- Participants that exercise more than three times per week or strength train more than twice per week.
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 |
|---|---|---|
| Exercise TrainingChronic High-Intensity Resistance Training | Other | Intervention |
Primary outcome
Change in Serum irisin levels
Time frame: Baseline and 3 weeks
Blood Lactate levels
Time frame: 3 weeks
Intensity of exercise on sessions 1, 3, 6 and 9
Changes in physical fitness levels as meassured by 1RM (repetition maximum) and Cardio-respiratory maximal testing
Time frame: Baseline and 3 weeks
Changes in Body composition assessment: DEXA and anthropometry
Time frame: Baseline and 3 weeks
Changes in Blood glucose levels
Time frame: Baseline and 3 weeks
Changes in Hematocrit concentration
Time frame: Baseline and 3 weeks
Diet assessment: 24 hour recall and Food Preference Questionnaire
Time frame: 3 weeks
Physical Activity assessment: accelerometry
Time frame: 3 weeks
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 20 Oct 2015.
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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.
Maria Fernandez del Valle, PhD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Healthy, run by Texas Tech University 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 0 inclusion and 10 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 20 Oct 2015. 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?
Change in Serum irisin levels (time frame: Baseline and 3 weeks). The study lists 8 primary outcomes in all. 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 20 Oct 2015.