Graded Exercise Therapy Guided Self-Help Trial for Patients with Chronic Fatigue Syndrome (GETSET): Protocol for a Randomized Controlled Trial and Interview Study

Abstract

BackgroundChronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME), is characterized by chronic disabling fatigue and other symptoms, which are not explained by an alternative diagnosis. Previous trials have suggested that graded exercise therapy (GET) is an effective and safe treatment. GET itself is therapist-intensive with limited availability.ObjectiveWhile guided self-help based on cognitive behavior therapy appears helpful to patients, Guided graded Exercise Self-help (GES) is yet to be tested.MethodsThis pragmatic randomized controlled trial is set within 2 specialist CFS/ME services in the South of England. Adults attending secondary care clinics with National Institute for Health and Clinical Excellence (NICE)-defined CFS/ME (N=218) will be randomly allocated to specialist medical care (SMC) or SMC plus GES while on a waiting list for therapist-delivered rehabilitation. GES will consist of a structured booklet describing a 6-step graded exercise program, supported by up to 4 face-to-face/telephone/Skype™ consultations with a GES-trained physiotherapist (no more than 90 minutes in total) over 8 weeks. The primary outcomes at 12-weeks after randomization will be physical function (SF-36 physical functioning subscale) and fatigue (Chalder Fatigue Questionnaire). Secondary outcomes will include healthcare costs, adverse outcomes, and self-rated global impression change scores. We will follow up all participants until 1 year after randomization. We will also undertake qualitative interviews of a sample of participants who received GES, looking at perceptions and experiences of those who improved and worsened.ResultsThe project was funded in 2011 and enrolment was completed in December 2014, with follow-up completed in March 2016. Data analysis is currently underway and the first results are expected to be submitted soon.ConclusionsThis study will indicate whether adding GES to SMC will benefit patients who often spend many months waiting for rehabilitative therapy with little or no improvement being made during that time. The study will indicate whether this type of guided self-management is cost-effective and safe. If this trial shows GES to be acceptable, safe, and comparatively effective, the GES booklet could be made available on the Internet as a practitioner and therapist resource for clinics to recommend, with the caveat that patients also be supported with guidance from a trained physiotherapist. The pragmatic approach in this trial means that GES findings will be generalizable to usual National Health Service (NHS) practice.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRTCTN): 22975026; http://www.isrctn.com/ISRCTN22975026 (Archived by WebCite at http://www.webcitation.org/6gBK00CUX)

Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial

“…We followed ethical guidance from the Medical Research Council Good Clinical Practice Guide, which recommends adherence to the 1996 version of the Declaration of Helsinki. The study protocol has been published 12 . At the time of publication, approvals were being sought to make suitably anonymised data available for external researchers to request through the Yale University Open Data Access (YODA) Project, which is prepared to share these data.…”

“…Safety outcomes were non-serious adverse events, serious adverse events, serious adverse reactions to trial interventions, serious deterioration, and active withdrawal from intervention 12 . Adverse events were self-reported by participants in the follow-up questionnaire in response to specific questions regarding any new health problem since the start of the trial.…”

“…Adverse events were considered serious if they involved death, hospital admission, increased severe and persistent disability, or self-harm, or when they were life-threatening or required an intervention to prevent one of these events. SMC clinicians and GES physiotherapists reported possible serious adverse events and reactions to the centre leader, and appropriate action was taken 12 . Two suitably qualified scrutineers who were masked from intervention allocation reviewed all such adverse events, independently from the trial team, to establish whether there were any further serious adverse events.…”

Guided graded Exercise Self-help for chronic fatigue syndrome: patient experiences and perceptions

“…Participants were recruited to the GETSET trial (n=211) at the time of being placed on the waiting list for treatment at one of two NHS specialist CFS/ME secondary care clinics in the south of England [22]. All participants had at least one SMC consultation, delivered by doctors with specialist experience in CFS/ME.…”

“…Study inclusion criteria included a diagnosis of NICE-defined CFS/ME [1], in order to ensure generalisability to secondary care in the UK. Patients were excluded if they: could not speak and/or read English adequately; had current suicidal thoughts; had read the GES guide previously; had had previous GET at one of the trial clinics; had physical contraindications to exercise; or were under 18 years old [22].…”