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A controlled study of the effects of a supervised cardiovascular fitness training program on the manifestations of primary fibromyalgia
McCain GA, Bell DA, Mai FM, Halliday PD
Arthritis and Rheumatism 1988 Sep;31(9):1135-1141
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; 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*

Forty-two patients with primary fibromyalgia were randomised into a 20-week program consisting of either cardiovascular fitness (CVR) training or simple flexibility exercises (FLEX) that did not lead to enhanced cardiovascular fitness. Patients were supervised by the same medical fitness instructors. Patients in neither group had contact with members of the other group, and were blinded as to the exercise taught to the alternative group. Groups met for 60 minutes 3 times each week. The compliance rate was 90%. Thirty-eight patients completed the study (18 with CVR training and 20 with FLEX). Blind assessments (standardized in preliminary trials to achieve acceptable inter-rater agreement) were performed by the same 2 examiners. After 20 weeks, patients receiving CVR training showed significantly improved cardiovascular fitness scores compred with those receiving FLEX training (t[35] = -4.22, p < 0.003). Logistic regression analysis showed clinically and statistically significant improvements in pain threshold scores, which were measured directly over fibrositic tender points, in patients undergoing CVR (t[35] = 2.21, p < 0.04). There was also a trend toward improvement in pain scores (visual analog scale) in the CVR group, but this did not reach statistical significance. There was no improvement in the percentage of body area affected by fibrositic symptoms or the number of nights per week or hours per night of disturbed sleep (self-report inventories). However, compared with the FLEX group, the CVR-trained patients improved significantly in both patient and physician global assessment scores. Because multidimensional symptom self-report inventory scores were similar in CVR-trained and FLEX-trained groups before and after exercise, improvements in the CVR-trained group were not the result of a reduction in psychological distress. Thus, a supervised cardiovascular fitness training program may provide some therapeutic benefit to selected patients with primary fibromyalgia syndrome.
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