Home Exercise for Older Diabetics
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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: | November 2014 |
| Estimated Primary Completion Date: | May 2014 (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 |
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| 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, Michigan | |
| VA Ann Arbor Healthcare System | Recruiting |
| Ann Arbor, Michigan, United States, 48113 | |
| Contact: Roger J Grekin, MD 734-845-3439 Roger.Grekin@va.gov | |
| Sub-Investigator: Caroline S. Blaum, MD | |
| Principal Investigator: Neil Alexander, MD | |
| 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: | March 5, 2013 |
| 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 May 21, 2013