Home Exercise to Enhance Mobility for Older Diabetics

November 6, 2018 updated by: VA Office of Research and Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfortable Gait Speed
Time Frame: 1 year
Gait velocity over 6 meters
1 year
Six Minute Walk Distance
Time Frame: one year
Walk distance covered in feet over 6 minutes
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: one year
Average physical activity counts per waking minute
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 3, 2011

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7547-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus Type 2

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe