AgingNCT02441205
Interval Training, Inflammation and Immune Function
A study testing High Intensity Interval training in people with Aging and Disease, run by Duke University at 1 site in United States.
Trial summary
PURPOSE: The purpose of this study is to investigate whether High Intensity Interval Training (HIIT)can improve the health and wellbeing of pre-diabetic elderly adults. In particular, there is specific interest in describing the effects of an interval exercise program on inflammatory state and immune function. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- What is being tested?
- High Intensity Interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 14 Nov 2016
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-80 years
- Prediabetic - Fasting plasma glucose is 100 - 125 on two separate days
- Able to walk for 2 minutes or more without stopping
- LDL Cholesterol ≤ 190; Triglycerides < 600;
- Blood Pressure ≤ 160/90
- Inactive: Exercise < 2 days per week
- Medications: Stable use of all medications ≥ three months
Who cannot join
- Smoker: tobacco use within the last 12 months
- Dieting or intending to diet; not weight stable ≥ six months (weight change < 5 pounds)
- Use of confounding inflammatory medications: aspirin, ibuprofen, naproxen (NSAIDS - nonsteriodal anti-inflammatory drugs)
- History of diabetes, heart disease or taking medications for those conditions
- History of hypertension (high blood pressure) not controlled with medication
- Unwillingness to undergo muscle biopsies and all other study testing, or to continuously participate in exercise training for 12 weeks.
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- Inability to give blood continuously through a catheter (please notify the study nurse of any difficulties you have had in the past when having your blood drawn; the study nurse will determine whether you are excluded for this reason)
- Unwillingness to conduct ALL exercise sessions at the fitness facility during research study staff supervised times.
- Orthopedic limitations, musculoskeletal disease and/or injury Due to the nature of the study, persons with known joint, muscle or other orthopedic limitations that restrict physical activity may be excluded.
- Able to decide if you want to take part in the study
- Lack of transportation to the exercise and testing facilities
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Living
Durham, North Carolina, 27705
About this study
Official title: The Impact of High Intensity Interval Training on Inflammatory State and Immune Function in Elderly Individuals
PURPOSE: The purpose of this study is to investigate whether High Intensity Interval Training (HIIT)can improve the health and wellbeing of pre-diabetic elderly adults. In particular, there is specific interest in describing the effects of an interval exercise program on inflammatory state and immune function.
DESIGN: Subjects will be sedentary, 65 to 80 years old adults, with prediabetes as defined by fasting plasma glucose (100 to 125 mg/dl). Before and after a 10-12 week High Intensity Interval Exercise training program subjects will undergo several tests including: 1) a maximal treadmill test, 2) an Oral Glucose Tolerance Test, 3) muscle biopsy, 4) body composition, 5) several physical function tests and 6) other health related measures including lung function, arterial stiffness and several blood measures (e.g. liver enzymes, kidney function).
Read more
DATA ANALYSES \& SAFETY ISSUES: As there are no comparison groups, data analyses will consist of performing paired t-tests on pre and post exercise training values for each of the measurement variables of interest. In addition, the data will be used to provide power calculations for future grant proposals. High Intensity Interval Training is a very safe exercise modality. The regular use of vigorous intensity exercise intervals have been used extensively in exercise training. In fact, the exercise intervals will start at levels lower and will be of shorter duration than were used during the maximal exercise test. They will then be carefully and slowly made to be more challenging as each subject is able to safely tolerate.
HYPOTHESIS: The investigators hypothesize that HIIT will result in significant improvements in markers of inflammation, immune system markers and other health-related risk factors.
- Being tested
- High Intensity Interval training
- Keywords
- High Intensity Interval Training
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval trainingBehavioural
all subjects will undergo high intensity interval training 3 x per week for 10-12 weeks. the intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| HIIT Aging | Experimental | all subjects will undergo high intensity interval training 3 x per week for 10-12 weeks. the intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes Receives: Behavioral: High Intensity Interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory markers in plasma
Measured: baseline and following exercise training, approximately 10-12 weeks
Change in inflammatory markers in muscle
Measured: baseline and following exercise training, approximately 10-12 weeks
Change in immune markers in peripheral blood
Measured: baseline and following exercise training, approximately 10-12 weeks
Change in immune markers in muscle
Measured: baseline and following exercise training, approximately 10-12 weeks
Secondary outcomes (1)
Change in Metabolic Syndrome risk factors composite score
Classic and additional Metabolic Syndrome measures include: blood pressure, waist circumference, triglycerides, HDL, fasting glucose; plus liver and kidney function, insulin sensitivity, glucose tolerance, etc...
Measured: baseline and following exercise training, approximately 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Kraus, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441205
- Sponsor's protocol ID
- Pro00055208
- Status last verified
- Feb 2017
- First submitted
- 9 Apr 2015
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartlett DB, Slentz CA, Willis LH, Hoselton A, Huebner JL, Kraus VB, Moss J, Muehlbauer MJ, Spielmann G, Muoio DM, Koves TR, Wu H, Huffman KM, Lord JM, Kraus WE. Rejuvenation of Neutrophil Functions in Association With Reduced Diabetes Risk Following Ten Weeks of Low-Volume High Intensity Interval Walking in Older Adults With Prediabetes - A Pilot Study. Front Immunol. 2020 May 5;11:729. doi: 10.3389/fimmu.2020.00729. eCollection 2020.
PubMed 32431698
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of High Intensity Interval Training on Inflammatory State and Immune Function in Elderly Individuals
- ClinicalTrials.gov ID
- NCT02441205
- Acronym / sponsor ID
- Pro00055208
- Keywords
- High Intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 12 May 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.
PURPOSE: The purpose of this study is to investigate whether High Intensity Interval Training (HIIT)can improve the health and wellbeing of pre-diabetic elderly adults. In particular, there is specific interest in describing the effects of an interval exercise program on inflammatory state and immune function.
DESIGN: Subjects will be sedentary, 65 to 80 years old adults, with prediabetes as defined by fasting plasma glucose (100 to 125 mg/dl). Before and after a 10-12 week High Intensity Interval Exercise training program subjects will undergo several tests including: 1) a maximal treadmill test, 2) an Oral Glucose Tolerance Test, 3) muscle biopsy, 4) body composition, 5) several physical function tests and 6) other health related measures including lung function, arterial stiffness and several blood measures (e.g. liver enzymes, kidney function).
DATA ANALYSES \& SAFETY ISSUES: As there are no comparison groups, data analyses will consist of performing paired t-tests on pre and post exercise training values for each of the measurement variables of interest. In addition, the data will be used to provide power calculations for future grant proposals. High Intensity Interval Training is a very safe exercise modality. The regular use of vigorous intensity exercise intervals have been used extensively in exercise training. In fact, the exercise intervals will start at levels lower and will be of shorter duration than were used during the maximal exercise test. They will then be carefully and slowly made to be more challenging as each subject is able to safely tolerate.
HYPOTHESIS: The investigators hypothesize that HIIT will result in significant improvements in markers of inflammation, immune system markers and other health-related risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIIT Aging | Experimental | Behavioral: High Intensity Interval trainingall subjects will undergo high intensity interval training 3 x per week for 10-12 weeks. the intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65-80 years
- Prediabetic - Fasting plasma glucose is 100 - 125 on two separate days
- Able to walk for 2 minutes or more without stopping
- LDL Cholesterol ≤ 190; Triglycerides < 600;
- Blood Pressure ≤ 160/90
Key exclusion criteria (11 listed)
- Smoker: tobacco use within the last 12 months
- Dieting or intending to diet; not weight stable ≥ six months (weight change < 5 pounds)
- Use of confounding inflammatory medications: aspirin, ibuprofen, naproxen (NSAIDS - nonsteriodal anti-inflammatory drugs)
- History of diabetes, heart disease or taking medications for those conditions
- History of hypertension (high blood pressure) not controlled with medication
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 |
|---|---|---|
| High Intensity Interval trainingall subjects will undergo high intensity interval training 3 x per week for 10-12 weeks. the intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes | Behavioural | HIIT Aging |
Primary outcome
Change in inflammatory markers in plasma
Time frame: baseline and following exercise training, approximately 10-12 weeks
Change in inflammatory markers in muscle
Time frame: baseline and following exercise training, approximately 10-12 weeks
Change in immune markers in peripheral blood
Time frame: baseline and following exercise training, approximately 10-12 weeks
Change in immune markers in muscle
Time frame: baseline and following exercise training, approximately 10-12 weeks
1 secondary outcome
Change in Metabolic Syndrome risk factors composite score
Time frame: baseline and following exercise training, approximately 10-12 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 9 Nov 2017.
- Derived from this study: PubMed 32431698Bartlett DB, Slentz CA, Willis LH, Hoselton A, Huebner JL, Kraus VB, Moss J, Muehlbauer MJ, Spielmann G, Muoio DM, Koves TR, Wu H, Huffman KM, Lord JM, Kraus WE. Rejuvenation of Neutrophil Functions in Association With Reduced Diabetes Risk Following Ten Weeks of Low-Volume High Intensity Interval Walking in Older Adults With Prediabetes - A Pilot Study. Front Immunol. 2020 May 5;11:729. doi: 10.3389/fimmu.2020.00729. eCollection 2020.
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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 Kraus, MD principal investigator
Duke 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 High Intensity Interval training in people with Aging and Disease, run by Duke 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 7 inclusion and 11 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 9 Nov 2017. 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 inflammatory markers in plasma (time frame: baseline and following exercise training, approximately 10-12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02441205, which also lists 1 linked publication.
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 9 Nov 2017; AzTrials last refreshed its copy on 2 Nov 2026.