Patients and methods

The study protocol was approved by the Tayside Committee on Research Medical Ethics. Seventy‐four patients who fulfilled the American College of Rheumatology's criteria for fibromyalgia [10] were recruited and allocated randomly to one of two treatment groups:

• (1) Demonstration of aerobic exercises plus stretching and relaxation techniques with tailoring for the individual patient's needs and abilities by a physiotherapist on one occasion. Written advice was given and patients were instructed to continue and gradually increase these exercises at home (the single session group);

or

• (2) Twelve weekly 1 h graded cardiovascular fitness classes plus stretching and relaxation techniques all supervised by a physiotherapist with written advice and encouragement to continue and increase these exercises at home (exercise class group).

In each group, exercises comprised a series of warming up and stretching exercises followed by a programme of graded circuit exercises consisting of step‐ups, sitting to standing, skipping, jogging on the spot, alternate side bends, circling arms with increasing weights.

The patients' attendance record at the classes was recorded.

Before entry to the study, informed consent was obtained and the following baseline information was recorded:

• (a) name, age, sex, duration of symptoms;

• (b) visual analogue pain scale consisting of a 10 cm line on which patients recorded the degree of pain experienced in the previous week;

• (c) total myalgic score—tenderness at the 18 tender points identified by Wolfe et al. [10] was measured using a dolorimeter and the sum of the forces required to produce pain was recorded;

• (d) modified Stanford Health Assessment Questionnaire (HAQ) [11];

• (e) hospital anxiety and depression questionnaire (HAD);

• (f) number of nights per week in which difficulty with sleep was experienced;

• (g) average number of hours slept each night over the previous 1 week;

• (h) resting pulse rate.

A routine cardiovascular and respiratory examination including blood pressure was made and recorded at baseline.

The patients were allowed tricyclic antidepressants, analgesics and non‐steroidal anti‐inflammatory drugs as indicated by the physician. However, treatment had to remain stable for 1 month prior to entry to the study.

Assessments (b) to (h) plus patients' assessment of percentage of recommended home exercises carried out and patients' assessment of change in pain from baseline based on a 7‐point score was repeated at 12, 24 and 48 weeks.

Statistical comparisons were carried out on an intention to treat basis both within the group and between groups using the appropriate non‐parametric statistics. Subgroup analysis was carried out on a treatment received basis. The study was designed to achieve a power of 90% (α = 0.05, β = 0.1) to demonstrate a change of 15 mm in the visual analogue pain score which we designated the primary outcome measure.

Results

Thirty‐seven patients were randomized to the exercise classes and 37 to the single session. Fifteen of the 37 allocated to the classes attended at least nine (75%) classes whereas 35 of the 37 allocated to the single session attended the session. The results were broadly similar for both the intention to treat analysis and treatment received (defined as attending 9/12 classes or the single session) and therefore only the results of the intention to treat analysis are presented, except where the analyses differ in detail, in which case, the results from both are presented. Table 1⇔ shows inter‐ and intra‐group comparisons for the various parameters. The only significant differences between group comparisons were for the anxiety component of the HAD score (in favour of the class). These differences were stronger on the treatment completed analysis (Table 2⇔). Although the HAQ score showed no difference between groups it did demonstrate a within‐group deterioration in the single session group. A deterioration at 24 weeks in the total myalgic score was seen for the classes. Patients' assessment of change in pain from baseline showed no significant differences on a 7‐point scale; median for both groups at 48 weeks was 5 (‘a little better’). The continuation rate of exercises at home was low in each group. After 12 weeks, patients randomized to the classes were carrying out 72% of their home exercises and those randomized to the single session 50% (medians). By 48 weeks these figures had fallen to 10% and 20%, respectively.

Discussion

The results of this study are disappointing. Although multiple comparisons were carried out, improvement with the classes was seen only in measures of psychological well‐being. In addition the classes failed to show the deterioration in functional status seen in the single session group. However, no improvement was seen in pain which is the presenting feature, and thus presumably the most important complaint of patients with fibromyalgia. No control group using no treatment was used. However, as both groups showed no significant improvements on within‐group analysis in these parameters it can be surmised that neither was effective in improving pain or tenderness. Furthermore, only the improvement in the depression component of the HAD was maintained at 1 yr.

Several randomized controlled studies [3–7] have found intensive aerobic exercise regimens to be useful and aerobic exercise is now regarded as a standard treatment for fibromyalgia. The exact programmes used in these studies differed but were generally more intensive than that used by ourselves and some, in addition, incorporated an education programme. The measures of efficacy used differed between these various studies. Three of these studies showed an improvement in total myalgic score [3–5], two [4, 5] showed an improvement in the number of tender points and one [5] showed an improvement in pain distribution. None of the studies showed a statistically significant improvement in the pain score. Wigers et al. [5] also showed an improvement in depression, lack of energy and work capacity. The two studies which did not contain randomized control groups [8, 9] showed improvements in the Fibromyalgia Impact Questionnaire; one of these [8] also showed improvement in the various measures of self‐efficacy and the other [9] in tenderness count. The duration of the exercise classes in these studies was from 6 weeks to 6 months. Both ourselves and Wigers et al. [5] found that compliance with home exercises after the formal exercise programme was poor and in our study fewer than half the patients attended even 75% of the classes, although Burckhardt et al. [8], who also included an education programme, found that the majority continued to do their exercises.

Thus, although the exercise class in our study differed in intensity from that in the previous studies, our disappointing results with regard to the patients' perception of pain are similar to these previous studies, although our power calculations were based on a 15 mm improvement on the visual analogue pain score and it is possible that a smaller but real improvement might have occurred. We also found no difference between the groups in patients' perception of overall improvement. At 48 weeks patients in both groups felt some improvement. This may represent the natural history of fibromyalgia, an improvement in both groups resulting from regular contact with the research nurse or a desire to please.

The answer to our original question comparing the two exercise programmes must be that they did not differ with respect to our primary outcome measure of visual analogue pain score. Some differences were seen, primarily in psychological status, although these were modest and ill‐sustained. From this study and a review of previous studies we must question the generally held view that aerobic exercise programmes are a major useful treatment for fibromyalgia. In the short term, improvement seems modest, useful long‐term benefit has not been found and compliance is poor.