NCT01308008

Brief Summary

The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this should create a model to which physicians and other providers could refer comorbid diabetes patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable diabetes-mellitus-type-2

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

First Submitted

Initial submission to the registry

March 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 8, 2018

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

4.5 years

First QC Date

March 1, 2011

Results QC Date

August 23, 2017

Last Update Submit

November 6, 2018

Conditions

Diabetes Mellitus Type 2

Keywords

Type 2 Diabetes MellitusMobility Limitation

Outcome Measures

Primary Outcomes (2)

  • Comfortable Gait Speed

    Gait velocity over 6 meters

    1 year

  • Six Minute Walk Distance

    Walk distance covered in feet over 6 minutes

    one year

Secondary Outcomes (1)

  • Physical Activity

    one year

Study Arms (2)

Functional exercise- home physical activity

EXPERIMENTAL

On-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with telephonic behavioral support

Behavioral: home exercise/physical activity (PA) enhancement program with behavioral support

Flex and tone- home health education

ACTIVE COMPARATOR

Initial on-site flex and toning program continued on follow-up along with health education

Behavioral: flex and toning health education program

Interventions

home exercise/physical activity (PA) enhancement program with behavioral supportBEHAVIORAL

Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support

Functional exercise- home physical activity
flex and toning health education programBEHAVIORAL

Initial flex and toning program continued on follow-up along with health education

Flex and tone- home health education

Eligibility Criteria

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

You may qualify if:

  • Sedentary
  • Type 2 Diabetes
  • No medical contraindications to exercise

You may not qualify if:

  • Enrolled in intensive exercise program
  • Unable to cooperate with protocol (e.g. cognitive impairment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Mobility Limitation

Interventions

ExerciseBehavior Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Study completed with depletion of funds.

Results Point of Contact

Title
Neil Alexander MD
Organization
VA GRECC
nalexand@umich.edu
734-845-3048

Study Officials

  • Neil Alexander, MD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 3, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2016

Study Completion

August 1, 2017

Last Updated

November 8, 2018

Results First Posted

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)