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Physical Activity and Participation
NA trial testing Counseling in Type 2 Diabetes Mellitus in 104 participants. Completed in 31 December 2019.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 1 June 2015 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
60 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 401.88 | ± 3909.59 |
| Wait-listed | -263.81 | ± 4414.79 |
Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 0.18 | ± 7.47 |
| Wait-listed | 0.63 | ± 8.43 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 0.35 | ± 8.14 |
| Wait-listed | 0.85 | ± 7.29 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention | -0.55 | ± 7.50 |
| Wait-listed | -0.36 | ± 7.40 |
Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down. Positive changes means worse outcome for timed up and go (seconds).
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 0.01 | ± 1.68 |
| Wait-listed | -0.25 | ± 2.69 |
Six month changes in gait speed, which is the comfortable gait peed in 10 meter walking. Positive changes means better outcomes for gait speed (meters per second).
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 0.01 | ± 0.14 |
| Wait-listed | 0.00 | ± 0.11 |
Six month changes in six-minute walk test, which measures the distance a participant walked at usual pace for six minutes. Positive changes means better outcomes for six-minute walk (meters).
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 4.23 | ± 45.97 |
| Wait-listed | 5.19 | ± 35.73 |
Time frame: For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention | Wait-listed Without OT-Led… | Wait-listed With OT-Led Co… |
|---|---|---|---|---|
| Minor , possibly study related adverse events | Musculoskeletal and connective tissue disorders | — | — | — |
| Minor, possibly study related adverse events | Musculoskeletal and connective tissue disorders | — | — | — |
| Minor, possibly related to the study | Musculoskeletal and connective tissue disorders | — | — | — |
Data from ClinicalTrials.gov NCT02268916 adverse events section.
The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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/NCT02268916.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing