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Therapeutics

Patient education to encourage graded exercise improved physical functioning in the chronic fatigue syndrome

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ACP J Club. 2001 Sep-Oct;135:46. doi:10.7326/ACPJC-2001-135-2-046

Related Content in this Issue
• Companion Abstract and Commentary: Cognitive behavior therapy reduced fatigue severity and functional impairment in the chronic fatigue syndrome


Source Citation

Powell P, Bentall RP, Nye FJ, Edwards RH. Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome. BMJ. 2001 Feb 17;322:387-90. [PubMed ID: 11179154] (All 2001 articles were reviewed for relevancy, and abstracts were last revised in 2007.)


Abstract

Question

In patients with the chronic fatigue syndrome (CFS), how effective is an education program in encouraging graded exercise and in improving physical function?

Design

Randomized (unclear allocation concealment*), unblinded,* controlled trial with 12-month follow-up.

Setting

Chronic fatigue clinic and an infectious diseases outpatient clinic in the United Kingdom.

Patients

148 patients (mean age 33 y, 78% women) who had the Oxford criteria for CFS and a score of < 25 on the physical functioning subscale of the Short Form-36 questionnaire. Exclusion criteria were having further physical investigations or taking other treatments; a history of psychotic illness, somatization disorder, eating disorder, or substance abuse; or being confined to a wheelchair or bed.

Intervention

Patients were allocated to 1 of 4 groups. 34 patients were allocated to standardized medical care (control group). Patients allocated to an intervention all received 2 individual treatment sessions and 2 telephone follow-up calls, supported by an educational package describing the role of disrupted physiologic regulation in fatigue symptoms and encouraging home-based graded exercise. The minimum intervention group (n = 37) had no further treatment, the telephone group (n = 39) received an additional 7 follow-up calls, and the maximum group (n = 38) received an additional 7 face-to-face sessions over 4 months.

Main outcome measures

The primary outcome was clinically important improvement at 1 year (a score of ≥ 25 or an increase of ≥ 10 from baseline on the physical functioning scale). Secondary outcomes included changes in fatigue, sleep, disability, and mood.

Main results

Analysis was by intention to treat with all patients included. More patients in the intervention groups met the criteria for clinical improvement than did those in the control group (Table), with no difference among the intervention groups. Fatigue, sleep, disability, and mood improved in the 3 intervention groups but not in the control group.

Conclusion

In the chronic fatigue syndrome, patient education to encourage graded exercise led to improved physical functioning.

*See Glossary.

Source of funding: Linbury Trust.

For correspondence: Dr. R.P. Bentall, Department of Psychology, Coupland 1 Building, University of Manchester, Manchester M13 9PL, England, UK. FAX 44-161-275-2588.


Table. Improvement at 1 year for minimum (MI), telephone (T), and maximum (MA) intervention vs control treatment in the chronic fatigue syndrome†

Comparisons Improvement RBI (95% CI) NNT (CI)
MI vs control 70% vs 6% 1095% (260 to 4270) 2 (2 to 3)
T vs control 69% vs 6% 1078% (254 to 4205) 2 (2 to 3)
MA vs control 68% vs 6% 1063% (250 to 4158) 2 (2 to 3)

†Abbreviations defined in Glossary; RBI, NNT, and CI calculated from data in article.


Commentary

5 randomized controlled trials (RCTs) of rehabilitative approaches for CFS in secondary care have been previously published. The first trial by Lloyd and colleagues (1) found that brief CBT was no better than medical care. Subsequent trials using more intensive treatment found substantial benefits over both usual care and relaxation therapy (2, 3). 2 RCTs of supervised, simple, graded exercise therapy (GET)—both of which showed some, although less, benefit—have also been published (4, 5). These trials were all of intensive therapy given by skilled practitioners in special centers. If therapy was better targeted, could less intensive treatment work? Could less skilled therapists deliver effective treatment? Are patient self-help groups as effective as these treatments?

Powell and colleagues addressed the value of better targeted, but briefer, treatment. Although called “educational,” the treatment was similar to CBT and GET but emphasized providing a physiologic rationale for rehabilitation. The results were remarkable: Although the usual-care group changed minimally, all 3 intervention groups, even the minimal one, improved substantially. This trial suggests that a brief intervention can work, perhaps because it used a rationale that was consistent with patients' own understanding of their illness.

Prins and colleagues' well-designed study was marred only by limited patient adherence to treatment and attrition in follow-up. This study showed that CBT could offer substantial benefit over usual care, even when delivered by nonexperts in nonspecialist centers. Interestingly, support groups satisfied patients but did not improve outcomes.

What can we conclude? 7 RCTs now exist using rehabilitative approaches for CFS, and 6 have shown benefits. Although the names of the interventions have varied, all are forms of rehabilitation (6). However, important caveats are noted: The total number of patients in these RCTs remains relatively small. Patients who cannot attend outpatient facilities have been excluded. Although most patients achieve improved functioning, they often continue to report excessive fatigue, and some patients do not respond at all. Finally, some patient organizations will not welcome these new findings. The reasons given are 1) the treatments are not a cure; 2) success of psychological therapy implies that CFS is psychological a psychological disorder; and 3) such treatments can be harmful. Adverse effects have rarely been reported in these trials but should be in future trials.

We now need large pragmatic trials that evaluate the utility of rehabilitative approaches in routine practice and explanatory trials to clarify which treatment components are most potent. Finally, we need to establish the place for rehabilitation in the medical care of CFS and related syndromes, and we need to ensure that it is delivered in a form acceptable to patients. These trials are useful steps along that road.

Michael Sharpe, MA
University of Edinburgh
Edinburgh, Scotland, UK


References

1. Lloyd AR, Hickie I, Brockman A, et al. Immunologic and psychologic therapy for patients with chronic fatigue syndrome: a double-blind, placebo-controlled trial. Am J Med. 1993;94:197-203. [PubMed ID: 8430715]

2. Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry. 1997;154:408-14. [PubMed ID: 9054791]

3. Sharpe M, Hawton K, Simkin S, et al. Cognitive behaviour therapy for the chronic fatigue syndrome: a randomized controlled trial. BMJ. 1996;312:22-6. [PubMed ID: 8555852]

4. Fulcher KY, White PD. Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome. BMJ. 1997;314:1647-52. [PubMed ID: 9180065]

5. Wearden AJ, Morriss RK, Mullis R, et al. Randomised double-blind, placebo-controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome. Br J Psychiatry. 1998;172:485-90. [PubMed ID: 9828987]

6. Sharpe M. Rehabilitative treatments for CFS: cognitive behavioural and graded exercise therapies. Baillieres Clinical Psychiatry. 1997;3:511-536. [No PMID]

7. Chambers D, Bagnall AM, Hempel S, Forbes C.Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review. J R Soc Med. 2006;99:506-20. [PubMed ID: 17021301]

8. Whiting P, Bagnall AM, Sowden AJ, et al.Interventoins for the treatment and managementof chornic fatigue syndrome: a systematic review. JAMA. 2001;286:1360-8. [PubMed ID: 11569542]

9. Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G. Cognitive behaviour therapy for adolescents with chornic fatigue syndrome: randomised controlled trial. BMJ . 2005;330:14. [PubMed ID: 15585538]