Randomized clinical trial
Home orthostatic training in chronic fatigue syndrome – a randomized, placebo-controlled feasibility study
Article first published online: 12 NOV 2009
© 2009 The Authors. Journal Compilation © 2009 Stichting European Society for Clinical Investigation Journal Foundation
European Journal of Clinical Investigation
Volume 40, Issue 1, pages 18–24, January 2010
How to Cite
Sutcliffe, K., Gray, J., Tan, M. P., Pairman, J., Wilton, K., Parry, S. W. and Newton, J. L. (2010), Home orthostatic training in chronic fatigue syndrome – a randomized, placebo-controlled feasibility study. European Journal of Clinical Investigation, 40: 18–24. doi: 10.1111/j.1365-2362.2009.02225.x
- Issue published online: 18 DEC 2009
- Article first published online: 12 NOV 2009
- Received 21 July 2009; accepted 12 October 2009
- Autonomic function;
- chronic fatigue syndrome;
- tilt training
Eur J Clin Invest 2010; 40 (1): 18–24
Background Orthostatic (Tilt)-training is an effective treatment for neurally mediated hypotension (NMH). NMH is a frequent finding in chronic fatigue syndrome (CFS). We evaluated home orthostatic training (HOT) in CFS in a randomized placebo-controlled feasibility study.
Methods Thirty-eight patients with CFS (Fukuda Criteria) were randomly allocated to daily tilt training (n = 19) or sham training (n = 19) for 6 months. Haemodynamic responses to standing were performed in all subjects using continuous technology (Taskforce) at enrolment, week 1, 4 and 24. Symptom response and compliance were assessed using diaries.
Results Two patients (one from each arm) withdrew from the study. Fourteen patients in each group complied completely or partially, and patients found the training manageable and achievable. Compared to the sham group, blood pressure while standing dropped to 8·0 mmHg less in the HOT group at 4 weeks (95% CI: 1·0 to 15·0, P = 0·03). At 4 weeks, the HOT group had higher total peripheral resistance compared to the sham group; mean difference 70·2, 95% CI: −371·4 to 511·8. Changes were maintained at 6 months. There was no significant difference in fatigue between groups at 4 weeks (mean difference 1·4, 95% CI: −13·5 to 16·2), but there was a trend towards improvement in fatigue at 6 months. Compliers had lower fatigue compared to non-compliers.
Conclusions A placebo-controlled study of HOT in CFS is feasible. HOT is well tolerated and generally complied with. A likely physiological rationale for HOT in CFS is related to reductions in orthostatic intolerance. An adequately powered study including strategies to enhance compliance is warranted.