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Exercise therapy for stress-related mental disorder, a randomised controlled trial in primary care
Quartero AO, Burger H, Donker M, de Wit NJ
BMC Family Practice 2011 Jul 26;12(76):Epub
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; 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: To investigate whether a structured physical exercise programme (PEP) improves the recovery of general health in patients suffering from stress-related mental disorder (SMD). METHOD: STUDY DESIGN: Randomised open trial in general practice. Patients from two regions in the Netherlands were included between September 2003 and December 2005, and followed up for 12 weeks. INTERVENTION: The patients were referred to a physical therapist for instruction in and monitoring of physical exercise of an intermediate intensity. Following the Dutch Guidelines for Healthy Physical Exercise, the patients were instructed to exercise at least five times a week, for at least 30 minutes per day. Control group: usual care from the GP. OUTCOME: Primary: improvement of general health after 6 weeks according to the 'general health' dimension of the Short-Form 36. Secondary: total days off work, percentage that resumed work after 6 and 12 weeks, change in distress score and change in remaining SF36 dimensions after 6 and 12 weeks. RESULTS: Out of 102 randomised patients (mean age 43, 60 (59%) female), 70 (68%) completed the trial, of whom 31 were in the intervention group. After 6 weeks, the mean (SD) general health score was 54.6 (22.1) for the intervention group and 57.5 (19.2) for the controls. The corresponding effect size (Cohen's d with 95% confidence interval) from analysis of covariance was -0.06 (-0.41 to 0.30) indicating no effect on general health. No significant effects of the intervention were detected for any secondary outcome parameter either. CONCLUSION: Notwithstanding the relatively high drop-out rate, our results suggest that referral to a physical therapist for structured physical exercise is not likely to be very effective in improving recovery from SMD.

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