Home Exercise for Older Diabetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
Behavioral: home exercise/physical activity (PA) enhancement program with behavioral support
Behavioral: flex and toning health education program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home Program to Enhance Mobility in Older Veteran Diabetics

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 240
Study Start Date: November 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Active Comparator: Arm 2
Initial on-site flex and toning program continued on follow-up along with health education
Behavioral: flex and toning health education program
Initial flex and toning program continued on follow-up along with health education

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, 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308008

Contacts
Contact: Neil Alexander, MD (734) 769-7100 ext 7686 nalexand@umich.edu
Contact: Joanna Jennens, BS (734) 998-7422 jejnnens@med.umich.edu

Locations
United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48113
Contact: Neil Alexander, MD    734-769-7100 ext 7686    nalexand@umich.edu   
Sub-Investigator: Caroline S. Blaum, MD         
Principal Investigator: Neil Alexander, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Neil Alexander, MD VA Ann Arbor Healthcare System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01308008     History of Changes
Other Study ID Numbers: E7547-R
Study First Received: March 1, 2011
Last Updated: September 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Type 2 Diabetes Mellitus
Mobility Limitation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014