- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02441205
Interval Training, Inflammation and Immune Function
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).
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke Center For Living
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIIT Aging
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in inflammatory markers in plasma
Time Frame: baseline and following exercise training, approximately 10-12 weeks
|
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
|
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
|
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
|
baseline and following exercise training, approximately 10-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Metabolic Syndrome risk factors composite score
Time Frame: baseline and following exercise training, approximately 10-12 weeks
|
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...
|
baseline and following exercise training, approximately 10-12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Physical Function outcome measures composite score
Time Frame: baseline and following exercise training, approximately 10-12 weeks
|
Peak VO2, 400 meter walk time, short physical performance battery (SPPB)
|
baseline and following exercise training, approximately 10-12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Kraus, MD, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00055208
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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