Adults 50 to 85, any sex, with Diabetes Complications or Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Timed Up-and-Go TestPrimary· Baseline, 12-weeks, and 24 weeks
Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.
Baseline
Group
Value
95% CI
Exercise, Activity, and Self-management
19.4
14.8 – 23.9
Home and Phone Visit
20.7
15.6 – 25.7
12-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
18.2
13.4 – 22.9
Home and Phone Visit
18.8
13.6 – 24.1
24-week
Group
Value
95% CI
Exercise, Activity, and Self-management
16.7
12.1 – 21.3
Home and Phone Visit
21.3
16.0 – 26.7
Two-Minute Walk TestSecondary· Baseline, 12 weeks, and 24 weeks
Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.
Baseline
Group
Value
95% CI
Exercise, Activity, and Self-management
86.9
76.9 – 96.9
Home and Phone Visit
84.4
73.2 – 95.6
12-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
88.5
77.6 – 99.3
Home and Phone Visit
83.3
71.3 – 95.3
24-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
99.8
89.6 – 110.0
Home and Phone Visit
84.0
72.0 – 96.1
Five Meter Walk TestSecondary· Baseline, 12 weeks, and 24 weeks
Performance-based physical function test measures the time to walk 5 meters at the participant's "normal, everyday pace".
Self-report physical function questionnaire measures capacity to perform a list of specific functional tasks (e.g., walking upstairs, getting in and out of a vehicle. Scores range from being unable or hardly able (0) to having no problems (4). An average score across the 12-item questionnaire was used in the analysis. Lower numbers indicate less difficulty.
Baseline
Group
Value
95% CI
Exercise, Activity, and Self-management
2.2
1.7 – 2.8
Home and Phone Visit
2.1
1.5 – 2.8
12-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
2.6
2.0 – 3.2
Home and Phone Visit
2.0
1.3 – 2.6
24-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
2.7
2.1 – 3.3
Home and Phone Visit
2.4
1.7 – 3.0
Houghton ScaleSecondary· Baseline, 12 weeks, and 24 weeks
Self-report physical function questionnaire. The outcome is the sum of scores from each item (min 0, max 12). A higher score indicates higher self-report of physical function with the prosthesis.
Baseline
Group
Value
95% CI
Exercise, Activity, and Self-management
0.64
± 0.15
Home and Phone Visit
0.62
± 0.23
12-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
0.69
± 0.28
Home and Phone Visit
0.69
± 0.24
24-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
0.77
± 0.18
Home and Phone Visit
0.65
± 0.27
Patient-Specific Function ScaleSecondary· Baseline, 12 weeks, and 24 weeks
Self-report physical function questionnaire. The outcome is the average score for up to five participant-identified activities on a scale from 0-10 (min 0, max 10). Higher score indicates greater ability to perform functional activities.
Baseline
Group
Value
95% CI
Exercise, Activity, and Self-management
3.3
± 1.8
Home and Phone Visit
3.5
± 1.9
12 weeks
Group
Value
95% CI
Exercise, Activity, and Self-management
5.7
± 2.6
Home and Phone Visit
5.1
± 2.3
24 weeks
Group
Value
95% CI
Exercise, Activity, and Self-management
6.9
± 2.3
Home and Phone Visit
5.3
± 2.3
Physical Activity Step CountsSecondary· Baseline, 12 weeks, and 24 weeks
Instrumented physical activity measure, average step counts per day
Baseline
Group
Value
95% CI
Exercise, Activity, and Self-management
1305
726 – 1883
Home and Phone Visit
1369
724 – 2014
12-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
2439
1844 – 3035
Home and Phone Visit
1512
849 – 2175
24-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
2294
1716 – 2873
Home and Phone Visit
1510
840 – 2180
Self-Efficacy in Managing Chronic Disease QuestionnaireSecondary· Baseline, 12 weeks, and 24 weeks
Scale range is 1-10. The score for the scale is the mean of the six items, using a ten point scale. Higher number indicates higher self-efficacy.
Baseline
Group
Value
95% CI
Exercise, Activity, and Self-management
7.6
7.1 – 8.3
Home and Phone Visit
7.5
6.8 – 8.2
12-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
7.8
7.2 – 8.4
Home and Phone Visit
7.9
7.2 – 8.6
24-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
8.1
7.5 – 8.7
Home and Phone Visit
7.5
6.8 – 8.2
World Health Organization Disability Assessment ScaleSecondary· Baseline, 12 weeks, and 24 weeks
Scores ranging from 1 (no difficulty) to 5 (extreme difficulty/cannot do). Overall disability was calculated by summing the scores for the 12 items; higher scores indicated greater disability (score range: 12-60).
Baseline
Group
Value
95% CI
Exercise, Activity, and Self-management
26.2
22.9 – 29.6
Home and Phone Visit
27.5
23.7 – 31.3
12-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
24.2
20.9 – 27.6
Home and Phone Visit
25.3
21.5 – 29.2
24-Week
Group
Value
95% CI
Exercise, Activity, and Self-management
21.6
18.2 – 25.0
Home and Phone Visit
25.3
21.4 – 29.1
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 14 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01929018.