NCT00344240

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 3, 2010

Status Verified

April 1, 2007

Enrollment Period

3.1 years

First QC Date

June 23, 2006

Last Update Submit

February 2, 2010

Conditions

Keywords

type 2 diabetesexerciseactivity guidancehealth education

Outcome Measures

Primary Outcomes (2)

  • Functional mobility performance

  • Physical activity

Interventions

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of type 2 diabetes on medications
  • Age 60 or older
  • Able to attend local class 3 times per week for 10 weeks

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mobility Research Center

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor ActivityHealth Education

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Caroline S Blaum, MD

    University of Michigan. Ann Arbor Veterans Affairs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 26, 2006

Study Start

August 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 3, 2010

Record last verified: 2007-04

Locations