Overview

This trial is active, not recruiting.

Condition diabetes mellitus type 2
Treatments home exercise/physical activity (pa) enhancement program with behavioral support, flex and toning health education program
Phase phase 3
Sponsor VA Office of Research and Development
Start date November 2011
End date May 2016
Trial size 240 participants
Trial identifier NCT01308008, E7547-R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
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)
Initial on-site flex and toning program continued on follow-up along with health education
flex and toning health education program
Initial flex and toning program continued on follow-up along with health education

Primary Outcomes

Measure
Functional Mobility
time frame: 1 year

Eligibility Criteria

Male or female participants at least 60 years old.

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)

Additional Information

Official title Home Program to Enhance Mobility in Older Veteran Diabetics
Principal investigator Neil Alexander, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.