Trial Outcomes & Findings for Telerehabilitation Intervention to Promote Exercise for Diabetes (NCT NCT00334113)
NCT ID: NCT00334113
Last Updated: 2015-01-06
Results Overview
A self-report measure of minutes of physical activity over the previous 7 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
six months
Results posted on
2015-01-06
Participant Flow
Of the 89 participants were enrolled in this study, only 66 participants were randomized. Of the difference, 18 were determined to be ineligible (17 for medical reasons, 1 for other reasons), and 5 participants dropped out before randomization.
Participant milestones
| Measure |
TLC-PED
Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.
|
Treatment as Usual
This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
TLC-PED
Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.
|
Treatment as Usual
This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Telerehabilitation Intervention to Promote Exercise for Diabetes
Baseline characteristics by cohort
| Measure |
TLC-PED
n=32 Participants
Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.
|
Treatment as Usual
n=34 Participants
This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9 • n=99 Participants
|
62 years
STANDARD_DEVIATION 11 • n=107 Participants
|
63 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
7 Day Physical Activity Recall
|
370 minutes of physical activity in a week
STANDARD_DEVIATION 251 • n=99 Participants
|
341 minutes of physical activity in a week
STANDARD_DEVIATION 329 • n=107 Participants
|
355 minutes of physical activity in a week
STANDARD_DEVIATION 339 • n=206 Participants
|
PRIMARY outcome
Timeframe: six monthsPopulation: Participants analyzed varies from completed participants since the completed number comes from those who stayed in the study through the 12 months (6 months post intervention). In TAU, the number who completed exceeds the number analyzed since 1 participant did not show for the 6 month assessment but did show for the 12 month follow up assessment.
A self-report measure of minutes of physical activity over the previous 7 days.
Outcome measures
| Measure |
TLC-PED
n=32 Participants
Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
|
Treatment as Usual
n=30 Participants
This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity.
|
|---|---|---|
|
7-Day Physical Activity Recall (PAR)
|
319 minutes per week
Standard Deviation 251
|
360 minutes per week
Standard Deviation 329
|
Adverse Events
TLC-PED
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TLC-PED
n=32 participants at risk
Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
|
Treatment as Usual
n=34 participants at risk
This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity.
|
|---|---|---|
|
Cardiac disorders
Cardiac symptoms
|
3.1%
1/32
|
11.8%
4/34
|
|
Renal and urinary disorders
UTI
|
3.1%
1/32
|
0.00%
0/34
|
|
Endocrine disorders
hypoglycemia that resulted in hospitalization
|
9.4%
3/32
|
0.00%
0/34
|
|
Infections and infestations
fever of unknown origin that resulted in hospitalizaton
|
3.1%
1/32
|
0.00%
0/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tonsillar cancer that resulted in hospitalizaton
|
0.00%
0/32
|
2.9%
1/34
|
|
Nervous system disorders
small stroke that resulted in hospitalization
|
0.00%
0/32
|
2.9%
1/34
|
Other adverse events
| Measure |
TLC-PED
n=32 participants at risk
Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
|
Treatment as Usual
n=34 participants at risk
This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
orthopedic pain/injury
|
18.8%
6/32
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis/pneumonia
|
6.2%
2/32
|
2.9%
1/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place