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Late effects of a brief psychological intervention in patients with intermittent claudication in a randomized clinical trial |
Cunningham MA, Swanson V, Holdsworth RJ, O'Carroll RE |
The British Journal of Surgery 2013 May;100(6):756-760 |
clinical trial |
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; 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* |
BACKGROUND: The authors previously reported the early results of a trial of a brief psychological intervention to increase physical activity in patients with intermittent claudication. After 4 months, participants in the intervention group walked a mean of 1,576 more steps per day than control group participants. The present study followed the original participants to determine whether this behaviour change was maintained over 2 years. METHODS: This was a randomized single-centre parallel-group trial. Fifty-eight patients newly diagnosed with intermittent claudication were assigned randomly to one of two groups. The control group (30 patients) received usual care: lifestyle advice and consultation with a vascular surgeon to agree a treatment plan. The treatment group (28) received usual care plus a brief psychological intervention designed to modify illness and walking beliefs, and develop a personalized walking action plan. The primary outcome was daily steps measured by pedometer. Secondary outcomes included revascularization rate, quality of life and perceived pain-free walking distance. Follow-up was conducted at 1 and 2 years. Between-group differences were analysed by analysis of co-variance. RESULTS: Participants in the brief psychological intervention group walked significantly more than those in the control group. The mean difference at 1 year was 1,374 (95% confidence interval 528 to 2,220) steps per day and the difference at 2 years was 1,630 (495 to 2,765) steps per day. CONCLUSION: Modifying illness and walking beliefs, and assisting patients to develop a personalized walking action plan led to increases in walking behaviour in patients with claudication that were maintained for 2 years. REGISTRATION NUMBER: ISRCTN28051878 (http://www.controlled-trials.com).
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