Home Exercise to Enhance Mobility for Older Diabetics

• ClinicalTrials.gov Identifier: NCT01308008
• Recruitment Status: Completed
• First Posted: March 3, 2011
• Results First Posted: November 8, 2018
• Last Update Posted: November 8, 2018
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus Type 2	Behavioral: home exercise/physical activity (PA) enhancement program with behavioral support; Behavioral: flex and toning health education program	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Home Program to Enhance Mobility in Older Veteran Diabetics
• Study Start Date: November 2011
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: August 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Functional exercise- home physical activity; 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	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: Flex and tone- home health education; 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Physical Activity [ Time Frame: one year ]
   Average physical activity counts per waking minute

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Michigan

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States, 48105

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Neil Alexander, MD; VA Ann Arbor Healthcare System, Ann Arbor, MI

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01308008
• Other Study ID Numbers: E7547-R
• First Posted: March 3, 2011
• Results First Posted: November 8, 2018
• Last Update Posted: November 8, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:

Type 2 Diabetes Mellitus; Mobility Limitation

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases