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Clinical Trials/NCT01308008
NCT01308008CompletedNot Applicable

Home Program to Enhance Mobility in Older Veteran Diabetics

VA Office of Research and Development1 site in 1 country144 target enrollmentStarted: November 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
144
Locations
1
Primary Endpoint
Six Minute Walk Distance

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

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

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

Flex and tone- home health education

Active Comparator

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

Intervention: flex and toning health education program (Behavioral)

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)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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