Graded exercise therapy
The information we share about graded exercise therapy (GET) is not a recommendation.
The October 2021 NICE guideline for M.E./CFS advises health professionals as follows (section 1.11.14):
"Do not offer people with ME/CFS:
- any therapy based on physical activity or exercise as a cure for ME/CFS
- generalised physical activity or exercise programmes – this includes programmes developed for healthy people or people with other illnesses
- any programme that does not follow the approach in recommendation 1.11.13 [see below] or that uses fixed incremental increases in physical activity or exercise, for example, graded exercise therapy (GET)
- physical activity or exercise programmes that are based on deconditioning and exercise avoidance theories as perpetuating ME/CFS."
What is GET?
The NICE guideline for M.E./CFS defines GET as follows (page 32):
"Graded exercise therapy is a term used in varying ways by different services supporting people with ME/CFS. In this guideline, graded exercise therapy is defined as first establishing an individual's baseline of achievable exercise or physical activity, then making fixed incremental increases in the time spent being physically active. This definition of graded exercise therapy reflects the descriptions given in the evidence that was reviewed, and it is this approach that the guideline says should not be undertaken. An individualised approach that should be taken for people with ME/CFS who choose to undertake a physical activity or exercise programme is described in recommendations 1.11.10 to 1.11.13."
Recommendations 1.11.10 to 1.11.13 give advice on how to ensure physical activity is personalised and led by the person with M.E./CFS, the need to understand the the risks and benefits of physical activity and exercise programmes, and that activity should be overseen by a physiotherapist in a specialist M.E./CFS team.
Instead of GET, some disease experts recommend that patients manage their activities to stay within their “energy envelope” to prevent crashes and possible long-term worsening from post-exertional malaise (ie. pacing). This is the symptom management approach that the majority of people with M.E. consistently tell us offers them the most benefit.
Why was GET removed from the NICE guideline?
In its comprehensive evidence review for the updated October 2021 guideline, the NICE guideline committee reports (page 368):
"Evidence from 12 randomised controlled trials were identified for graded exercise therapy. Six studies compared graded exercise therapy to usual care, two studies to flexibility/relaxation, and single studies compared graded exercise therapy to heart rate variability feedback, adaptive pacing, intermittent exercise, and activity dairies. The quality of the evidence ranged from low to very low quality. No evidence was identified for mortality, care needs and impact on families and carers. The severity of ME/CFS was mixed or unclear in all of the studies and one study included young people and adults."
One of the studies they looked at was the 2011 PACE trial - see more on this below.
Regarding other types of exercise interventions, the review continues: "Evidence from 3 randomised controlled trials compared types of exercise (intermittent exercise, orthostatic training and qigong) to non-active controls (usual care, sham, no treatment) and 1 randomised controlled trial compared anaerobic activity therapy to cognitive therapy or relaxation. The quality of the evidence was very low quality. No evidence was identified for mortality, cognitive function, psychological status, pain, sleep quality, treatment-related adverse events, activity levels, care needs and impact on families and carers."
Evidence and patient experience
There is no high-quality, peer-reviewed published evidence to support either the efficacy or the safety of GET, whoever provides it, while patient surveys consistently find that GET makes symptoms worse, or makes no difference. A small minority of people with M.E. tell us that they find GET useful; many others do not and a significant number report an increase in symptoms following GET.
Action for M.E.’s 2019 Big Survey of more than 4,000 people with M.E. found that:
- less than one in ten (6%) respondents said GET helps/has helped manage symptoms, while 13% said it made no difference
- more than a third (38%) said it worsened symptoms.
A large number of people who completed our survey said that GET is making their symptoms worse. Even when GET is undertaken with a practitioner who understands how the condition affects the person with M.E., offers a supportive and collaborative relationship and is an equal partner in the treatment, it is having a worsening effect on symptoms.
Outcomes are worse for those who saw an M.E. specialist with almost half experiencing a worsening of symptoms. GET only helped 4% of those who saw a health professional who does not specialise in M.E. with almost two thirds (61%) having a worsening of symptoms.
A 2019 survey by Forward M.E., undertaken at the request of the NICE guideline development group as part of its current guideline review, found that 540 of the 2,280 survey respondents had been offered a course of GET, with 79% starting the course. We asked them:
- if their symptoms worsened because of the treatment; 81% said yes, 13% said no; 37% also developed new symptoms
- what impact GET had on their physical health; 67% said it deteriorated; 13% said it improved; 12% said no improvement
- what impact GET had on their mental health; 53% said it deteriorated; 26% said no improvement; 13% said it improved.
A 2017 analysis of surveys by Action for M.E. and other patient charities, published in the Journal of Health Psychology, suggests that GET brings about “negative responses” in 54% to 74% of patients. The paper cited [pacing] as the symptom-management approach that had the highest reported benefit.
Hear from people with M.E. and health professionals in the Dialogues for ME/CFS film about GET.
In 2018, government health authorities in the US and The Netherlands instructed clinicians to stop recommending CBT and GET as reliable treatments for people with M.E., citing the potential harms associated with GET in particular.
The PACE trial
The results of a large-scale study published in 2011, of adaptive pacing therapy, GET and CBT, called the PACE trial, found that some people with mild or moderate M.E. experienced a small degree of improvement after undertaking CBT and GET, and no significant improvement after adaptive pacing therapy.
However, the PACE trial was based on a flawed hypothesis that M.E. “was largely being maintained by abnormal illness beliefs and behaviours, along with inactivity and deconditioning” (Shepherd, 2017). Repeated questions have been raised about the methodology of this trial, and the reliability of its results, including potential harm caused by GET.