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Reducing sitting time after stroke. A phase II safety and feasibility randomised controlled trial |
English C, Healy GN, Olds T, Parfitt G, Borkoles E, Coates A, Kramer S, Bernhardt J |
Archives of Physical Medicine and Rehabilitation 2016 Feb;97(2):273-280 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To test the safety, feasibility and effectiveness of reducing sitting time in stroke survivors. DESIGN: Randomised controlled trial with attention-matched control and blinded assessments. SETTING: Community PARTICIPANTS: Thirty-five stroke survivors (22 male, mean age 66.9 +/- 12.7 years). INTERVENTIONS: Four counselling sessions over seven weeks with a message of 'sit less, move more' (intervention group) or 'calcium for bone health' (attention-matched control group). MAIN OUTCOME MEASURES: Safety (adverse events, increases in pain, spasticity or fatigue) and feasibility (adherence to trial protocol). Secondary measures included time spent sitting (including in prolonged bouts >= 30 mins), standing, and stepping as measured by the thigh-worn activPAL3 activity monitor (7 days, 24 hrs/day protocol) and time spent in physical activity of at least moderate intensity as measured by the actigraph GT3x+. The Multi-Media Activity Recall for Children and Adults (MARCA) was used to describe changes in use-of-time. RESULTS: Thirty-three participants completed the full protocol. Four participants reported falls during the intervention period with no other adverse events. From a baseline average of 640.7 (SD 99.6) min/day, daily sitting time reduced on average by 30.0 (SD 50.6) min/day (95% CI 5.8 to 54.6) in the intervention group and 40.4 (SD 92.5) min/day in the control group (95% CI 13.0 to 93.8). Participants in both groups also reduced their time spent in prolonged sitting bouts (>= 30 minutes) and increased time spent standing and stepping. CONCLUSIONS: Our protocol was both safe and feasible. Participants in both groups spent less time sitting and more time standing and stepping post-intervention, but outcomes were not superior for intervention participants. Attention-matching is desirable in clinical trials, and may have contributed to the positive outcomes for control participants.
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