Type 2 DiabetesNCT01417845
The Effect of Exercise Training Intensity in Patients With Type 2 Diabetes
A study testing High Intensity Exercise Training and Moderate Intensity Exercise Training in people with Type 2 Diabetes, run by University of Central Arkansas at 1 site in United States.
Trial summary
The purpose of this randomized clinical trial is to compare the effect of moderate versus high intensity exercise training on physical fitness and physical function in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- High Intensity Exercise Training and Moderate Intensity Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2012
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants meet the American Diabetes Association diagnostic criteria for type 2 diabetes.
- A physician must consider each participant to be medically stable to participate in this investigation.
Who cannot join
- Any individual with a history of a medical condition identified by the American Heart Association as an absolute contraindication to exercise testing is excluded from this study.
- Any individual with angina (stable or unstable), uncontrolled hypertension, proliferative retinopathy, severe peripheral neuropathy, nephropathy, autonomic neuropathy, history of coronary artery disease, history of myocardial infarction, or unable to participate in this study due to a physical impairment is excluded from this investigation.
- Any individual involved in resistance training or aerobic training within 3 months of the beginning of this investigation is excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Arkansas
Conway, Arkansas, 72035
About this study
Official title: The Effect of Moderate Versus High Intensity Exercise Training on Physical Fitness and Physical Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial
The purpose of this randomized clinical trial is to compare the effect of moderate versus high intensity exercise training on physical fitness and physical function in patients with type 2 diabetes. The research hypothesis is that high intensity exercise training will be superior to moderate intensity on such outcomes in individuals with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- High Intensity Exercise Training, Moderate Intensity Exercise Training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Exercise TrainingBehavioural
- High intensity resistance and aerobic training
- Resistance training is performed 2 days per week for 3 months
- Aerobic training is performed on the same days as resistance training and 1 additional day per week.
Moderate Intensity Exercise TrainingBehavioural
- Moderate intensity resistance and aerobic training
- Resistance training is performed on 2 days per week for 3 months.
- Aerobic training is performed on the same days as resistance training and 1 additional day per week.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Exercise | Experimental | High intensity resistance and aerobic training Receives: Behavioral: High Intensity Exercise Training |
| Moderate Intensity Exercise | Active comparator | Moderate intensity resistance and aerobic training Receives: Behavioral: Moderate Intensity Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Measured: Baseline and 3 months thereafter
Physical Function
Measured: Baseline and 3 months thereafter
Exercise Capacity
Measured: Baseline and 3 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2012
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 Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James David Taylor, PT, PhD, University of Central Arkansas
- Investigators
- James D Taylor, PhD, PT, Principal investigator, University of Central Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417845
- Sponsor's protocol ID
- UCA-IRB-11-077
- Status last verified
- Jan 2014
- First submitted
- 11 Aug 2011
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Taylor JD, Fletcher JP, Mathis RA, Cade WT. Effects of moderate- versus high-intensity exercise training on physical fitness and physical function in people with type 2 diabetes: a randomized clinical trial. Phys Ther. 2014 Dec;94(12):1720-30. doi: 10.2522/ptj.20140097. Epub 2014 Jul 31.
PubMed 25082918
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moderate Versus High Intensity Exercise Training on Physical Fitness and Physical Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01417845
- Acronym / sponsor ID
- UCA-IRB-11-077
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Central ArkansasUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (actual)
- First posted
- 16 Aug 2011 (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 randomized clinical trial is to compare the effect of moderate versus high intensity exercise training on physical fitness and physical function in patients with type 2 diabetes. The research hypothesis is that high intensity exercise training will be superior to moderate intensity on such outcomes in individuals with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Exercise | Experimental | Behavioral: High Intensity Exercise TrainingHigh intensity resistance and aerobic training |
| Moderate Intensity Exercise | Active comparator | Behavioral: Moderate Intensity Exercise TrainingModerate intensity resistance and aerobic training |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All participants meet the American Diabetes Association diagnostic criteria for type 2 diabetes.
- A physician must consider each participant to be medically stable to participate in this investigation.
Key exclusion criteria (3 listed)
- Any individual with a history of a medical condition identified by the American Heart Association as an absolute contraindication to exercise testing is excluded from this study.
- Any individual with angina (stable or unstable), uncontrolled hypertension, proliferative retinopathy, severe peripheral neuropathy, nephropathy, autonomic neuropathy, history of coronary artery disease, history of myocardial infarction, or unable to participate in this study due to a physical impairment is excluded from this investigation.
- Any individual involved in resistance training or aerobic training within 3 months of the beginning of this investigation is excluded.
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 Exercise Training* High intensity resistance and aerobic training * Resistance training is performed 2 days per week for 3 months * Aerobic training is performed on the same days as resistance training and 1 additional day per week. | Behavioural | High Intensity Exercise |
| Moderate Intensity Exercise Training* Moderate intensity resistance and aerobic training * Resistance training is performed on 2 days per week for 3 months. * Aerobic training is performed on the same days as resistance training and 1 additional day per week. | Behavioural | Moderate Intensity Exercise |
Primary outcome
Muscle Strength
Time frame: Baseline and 3 months thereafter
Physical Function
Time frame: Baseline and 3 months thereafter
Exercise Capacity
Time frame: Baseline and 3 months thereafter
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 3 Feb 2014.
- Derived from this study: PubMed 25082918Taylor JD, Fletcher JP, Mathis RA, Cade WT. Effects of moderate- versus high-intensity exercise training on physical fitness and physical function in people with type 2 diabetes: a randomized clinical trial. Phys Ther. 2014 Dec;94(12):1720-30. doi: 10.2522/ptj.20140097. Epub 2014 Jul 31.
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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.
James D Taylor, PhD, PT principal investigator
University of Central Arkansas
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 Exercise Training and Moderate Intensity Exercise Training in people with Type 2 Diabetes, run by University of Central Arkansas 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 2 inclusion and 3 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 3 Feb 2014. 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?
Muscle Strength (time frame: Baseline and 3 months thereafter). The study lists 3 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 NCT01417845, 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 3 Feb 2014.