Type 2 DiabetesNCT00344240
Exercise and Activity Guidance in Older Adults With Diabetes
A study testing Functional circuit training with lifestyle behavior in people with Type 2 Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of the project is to better understand how exercise and education will help mobility and health in older adults with diabetes. The investigators are trying to learn what type of exercises and classes are needed to help older adults stay active. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Functional circuit training with lifestyle behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Sep 2008
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of type 2 diabetes on medications
- Age 60 or older
- Able to attend local class 3 times per week for 10 weeks
Who cannot join
- Ejection fraction <40%
- Symptomatic obstructive valvular disease (primarily aortic stenosis)
- Atrial fibrillation with poor rate control (particularly during exercise), or high grade AV block
- Substantial dementia (Folstein Mini Mental State Examination <24 out of 30)
- Blood tests suggesting severe renal (Cr>3.0) or hepatic (transaminases>4x normal) disease
- Alcohol intake >3 oz/day
Show all 11Show fewer
- Hemiplegia or lower limb amputation
- Participating in regular exercise 2 or more hours per week.
- Significant orthopedic or musculoskeletal condition that limits weight bearing
- Acute medical conditions, such as acute flare-up of joint condition or infection
- Normal FBS in those with equivocal diabetes history (< 130)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Performance,Mobility Limitations and Exercise in Older Adults With Diabetes
The purpose of the project is to better understand how exercise and education will help mobility and health in older adults with diabetes. The investigators are trying to learn what type of exercises and classes are needed to help older adults stay active. This knowledge will eventually prove useful in helping patients and doctors understand what is needed to keep older adults with Type 2 diabetes as healthy as possible.
Read the detailed description
- Information and health screening: Interested persons are screened for eligibility and undergo a directed medical history and examination, echocardiogram (if not done within one year), limited ABI test, and maximal treadmill test with oxygen kinetics.
- Measure fitness level at the beginning of the exercise training, at 10 and 20 weeks: DEXA scan, body fat analysis, strength and balance measurements, and blood tests.
- Train for 10 weeks in a supervised small group format. Classes meet three times a week for an hour. Participants are randomly assigned to:
- Flexibility and toning exercises + health education, or 2) Functional circuit training + home activities + tailored physical activity guidance.
- Follow-up phone calls for an additional 10 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- Functional circuit training with lifestyle behavior
- Keywords
- type 2 diabetes, exercise, activity guidance, health education
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional circuit training with lifestyle behaviorBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility performance
Physical activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2008
- Study completionSep 2008
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.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Investigators
- Caroline S Blaum, MD, Principal investigator, University of Michigan. Ann Arbor Veterans Affairs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344240
- Sponsor's protocol ID
- 2004-0966
- Status last verified
- Apr 2007
- First submitted
- 23 Jun 2006
- Last updated
- 3 Feb 2010
- Results posted
- No
Publications
Lee PG, Ha J, Blaum CS, Gretebeck K, Alexander NB. Patterns of physical activity in sedentary older individuals with type 2 diabetes. Clin Diabetes Endocrinol. 2018 Apr 10;4:7. doi: 10.1186/s40842-018-0057-4. eCollection 2018.
PubMed 29662686
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Performance,Mobility Limitations and Exercise in Older Adults With Diabetes
- ClinicalTrials.gov ID
- NCT00344240
- Acronym / sponsor ID
- 2004-0966
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, exercise, activity guidance, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Aug 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 Jun 2006 (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 the project is to better understand how exercise and education will help mobility and health in older adults with diabetes. The investigators are trying to learn what type of exercises and classes are needed to help older adults stay active. This knowledge will eventually prove useful in helping patients and doctors understand what is needed to keep older adults with Type 2 diabetes as healthy as possible.
Detailed description
- Information and health screening: Interested persons are screened for eligibility and undergo a directed medical history and examination, echocardiogram (if not done within one year), limited ABI test, and maximal treadmill test with oxygen kinetics.
- Measure fitness level at the beginning of the exercise training, at 10 and 20 weeks: DEXA scan, body fat analysis, strength and balance measurements, and blood tests.
- Train for 10 weeks in a supervised small group format. Classes meet three times a week for an hour. Participants are randomly assigned to:
- Flexibility and toning exercises + health education, or 2) Functional circuit training + home activities + tailored physical activity guidance.
- Follow-up phone calls for an additional 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of type 2 diabetes on medications
- Age 60 or older
- Able to attend local class 3 times per week for 10 weeks
Key exclusion criteria (11 listed)
- Ejection fraction <40%
- Symptomatic obstructive valvular disease (primarily aortic stenosis)
- Atrial fibrillation with poor rate control (particularly during exercise), or high grade AV block
- Substantial dementia (Folstein Mini Mental State Examination <24 out of 30)
- Blood tests suggesting severe renal (Cr>3.0) or hepatic (transaminases>4x normal) disease
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 |
|---|---|---|
| Functional circuit training with lifestyle behavior | Behavioural | – |
Primary outcome
Functional mobility performance
Physical activity
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 2010.
- Derived from this study: PubMed 29662686Lee PG, Ha J, Blaum CS, Gretebeck K, Alexander NB. Patterns of physical activity in sedentary older individuals with type 2 diabetes. Clin Diabetes Endocrinol. 2018 Apr 10;4:7. doi: 10.1186/s40842-018-0057-4. eCollection 2018.
- Mobility Research CenterLink provided by the sponsor.
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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.
Caroline S Blaum, MD principal investigator
University of Michigan. Ann Arbor Veterans Affairs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional circuit training with lifestyle behavior in people with Type 2 Diabetes, run by University of Michigan 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 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 3 Feb 2010. 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?
Functional mobility performance. The study lists 2 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 NCT00344240, 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 2010.