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Clinical Trials/NCT01308008
NCT01308008
Completed
N/A

Home Program to Enhance Mobility in Older Veteran Diabetics

VA Office of Research and Development1 site in 1 country144 target enrollmentNovember 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
VA Office of Research and Development
Enrollment
144
Locations
1
Primary Endpoint
Six Minute Walk Distance
Status
Completed
Last Updated
7 years ago

Overview

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.

Detailed Description

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. To facilitate adherence to a long-term program, the investigators plan an individualized, home exercise/physical activity (PA) enhancement program with behavioral support. The rationale for this program is based on: 1) the feasibility of a previously funded VA RR\&D controlled trial (led by the present research team) in sedentary older adults with diabetes that improved mobility performance, specifically usual gait speed; 2) the need for longer term and functionally-relevant interventions (specifically mobility-oriented) for older adult diabetics; 3) the potential to use telephonic nurse support to assist in overcoming barriers to exercise and in dealing with intercurrent illness, factors that are key in this comorbid patient group; and 4) the potential to increase the focus on objectively measured 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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
August 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Six Minute Walk Distance

Time Frame: one year

Walk distance covered in feet over 6 minutes

Comfortable Gait Speed

Time Frame: 1 year

Gait velocity over 6 meters

Secondary Outcomes

  • Physical Activity(one year)

Study Sites (1)

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