Home Exercise for Older Diabetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01308008
First received: March 1, 2011
Last updated: March 24, 2014
Last verified: March 2014

March 1, 2011
March 24, 2014
November 2011
May 2014   (final data collection date for primary outcome measure)
Functional Mobility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Primary measures that embed walking, including timed up and go, comfortable gait speed, and 6 minute walk distance
Same as current
Complete list of historical versions of study NCT01308008 on ClinicalTrials.gov Archive Site
Not Provided
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Home Exercise for Older Diabetics
Home Program to Enhance Mobility in Older Veteran 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.

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, we 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Behavioral: home exercise/physical activity (PA) enhancement program with behavioral support
    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
  • Behavioral: flex and toning health education program
    Initial flex and toning program continued on follow-up along with health education
  • Experimental: Arm 1
    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
    Intervention: Behavioral: home exercise/physical activity (PA) enhancement program with behavioral support
  • Active Comparator: Arm 2
    Initial on-site flex and toning program continued on follow-up along with health education
    Intervention: Behavioral: flex and toning health education program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
November 2014
May 2014   (final data collection date for primary outcome measure)

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)
Both
60 Years and older
No
Contact: Neil Alexander, MD (734) 769-7100 ext 7686 nalexand@umich.edu
Contact: Joanna Jennens, BS (734) 998-7422 jejnnens@med.umich.edu
United States
 
NCT01308008
E7547-R
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Neil Alexander, MD VA Ann Arbor Healthcare System
Department of Veterans Affairs
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP