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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional exercise- home physical activity | Experimental | 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 |
|
| Flex and tone- home health education | Active Comparator | Initial on-site flex and toning program continued on follow-up along with health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home exercise/physical activity (PA) enhancement program with behavioral support | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comfortable Gait Speed | Gait velocity over 6 meters | 1 year |
| Six Minute Walk Distance | Walk distance covered in feet over 6 minutes | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Average physical activity counts per waking minute | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Alexander, MD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
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Withdrawal after Screening, prior to Baseline: N=5
Participants were recruited in Ann Arbor, Michigan and surrounding communities. Recruitment relied primarily on media advertisement, community outreach and mailings to patients with diabetes treated at the Veterans Affairs Ann Arbor Healthcare System (VAAAHS) and the University of Michigan (UM), both of which provided IRB approval.
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Exercise- Home Physical Activity | 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 |
| FG001 | Flex and Tone- Home Health Education | Initial on-site flex and toning program continued on follow-up along with health education |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4 Weeks |
|
| ||||||||||||||||||
| 6 Months |
| |||||||||||||||||||
| 12 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comfortable Gait Speed | Gait velocity over 6 meters | Posted | Mean | Standard Deviation | meters per second | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Exercise- Home Physical Activity | Functional exercise- home physical activity |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Baker's cyst drainage | Musculoskeletal and connective tissue disorders |
Study completed with depletion of funds.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Alexander MD | VA GRECC | 734-845-3048 | nalexand@umich.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| flex and toning health education program | Behavioral | Initial flex and toning program continued on follow-up along with health education |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Flex and Tone- Home Health Education | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Comfortable gait speed | Gait velocity over 6 meters | Mean | Standard Deviation | meters per second |
|
Initial on-site flex and toning program continued on follow-up along with health education
|
|
|
| Primary | Six Minute Walk Distance | Walk distance covered in feet over 6 minutes | Posted | Mean | Standard Deviation | feet | one year |
|
|
|
|
| Secondary | Physical Activity | Average physical activity counts per waking minute | Posted | Mean | Standard Deviation | counts per minute | one year |
|
|
|
|
| 0 |
| 71 |
| 3 |
| 71 |
| 0 |
| 71 |
| EG001 | Flex and Tone- Home Health Education | Flex and tone- health education | 0 | 73 | 3 | 73 | 2 | 73 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| hyperkalemia | Metabolism and nutrition disorders |
|
| Partial achilles tendon tear | Musculoskeletal and connective tissue disorders | Unrelated to training (s/p fall off bike) |
|
| Colonic polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| hand pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | post hand grip testing |
|
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| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |