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NCT Number: NCT01308008

Home Exercise to Enhance Mobility for Older Diabetics

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Behavioral

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

flex and toning health education program

Behavioral

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

Primary outcomes

  1. Comfortable Gait Speed

    Time frame: 1 year

    Gait velocity over 6 meters

  2. Six Minute Walk Distance

    Time frame: one year

    Walk distance covered in feet over 6 minutes

Secondary outcomes

  1. Physical Activity

    Time frame: one year

    Average physical activity counts per waking minute

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Home Program to Enhance Mobility in Older Veteran Diabetics

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Mar 3, 2011
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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