Diabetes Mellitus Type 2
Conditions
Keywords
Type 2 Diabetes Mellitus, Mobility Limitation
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.
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.
Interventions
BEHAVIORALhome 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
BEHAVIORALflex and toning health education program
Initial flex and toning program continued on follow-up along with health education
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfortable Gait Speed | 1 year | Gait velocity over 6 meters |
| Six Minute Walk Distance | one year | Walk distance covered in feet over 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | one year | Average physical activity counts per waking minute |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Withdrawal after Screening, prior to Baseline: N=5
Participants by arm
| Arm | Count |
|---|---|
| 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 | 71 |
| 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 | 73 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 4 Weeks | Illness, disinterest, time | 9 | 2 |
Baseline characteristics
| Characteristic | Functional Exercise- Home Physical Activity | Flex and Tone- Home Health Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 71 Participants | 73 Participants | 144 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 69 Years STANDARD_DEVIATION 6 | 70 Years STANDARD_DEVIATION 6 | 70 Years STANDARD_DEVIATION 6 |
| Comfortable gait speed | 1.1 meters per second STANDARD_DEVIATION 0.2 | 1.1 meters per second STANDARD_DEVIATION 0.2 | 1.1 meters per second STANDARD_DEVIATION 0.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 11 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 54 Participants | 58 Participants | 112 Participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 48 Participants |
| Sex: Female, Male Male | 49 Participants | 47 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 73 |
| other Total, other adverse events | 0 / 71 | 2 / 73 |
| serious Total, serious adverse events | 3 / 71 | 3 / 73 |
Outcome results
Primary
Comfortable Gait Speed
Gait velocity over 6 meters
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Functional Exercise- Home Physical Activity | Comfortable Gait Speed | 1.2 meters per second | Standard Deviation 0.2 |
| Flex and Tone- Home Health Education | Comfortable Gait Speed | 1.2 meters per second | Standard Deviation 0.2 |
p-value: 0.1695% CI: [-0.02, 0.13]Regression, Logistic
Primary
Six Minute Walk Distance
Walk distance covered in feet over 6 minutes
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Functional Exercise- Home Physical Activity | Six Minute Walk Distance | 1307 feet | Standard Deviation 234 |
| Flex and Tone- Home Health Education | Six Minute Walk Distance | 1271 feet | Standard Deviation 275 |
p-value: 0.1795% CI: [-15, 83]Regression, Logistic
Secondary
Physical Activity
Average physical activity counts per waking minute
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Functional Exercise- Home Physical Activity | Physical Activity | 170 counts per minute | Standard Deviation 89 |
| Flex and Tone- Home Health Education | Physical Activity | 141 counts per minute | Standard Deviation 66 |
p-value: 0.595% CI: [-35, 17]Regression, Logistic