Graded exercise therapy

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Graded exercise therapy
Other namesGET
Specialty Physical therapy

Graded exercise therapy (GET) is a programme of physical activity that starts very slowly and gradually increases over time, intended as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Most public health bodies, including the CDC and NICE, consider it ineffective, and its safety is disputed. [1] [2] [3] However, GET still enjoys support among a minority of clinicians and organizations.

Contents

Description

A graded exercise programme starts with a physiotherapist or exercise physiologist assessing the patient's current abilities and negotiating goals. The patient then begins exercising at a level within their capabilities. The patient and therapist increase the duration of sessions, typically by 10-20% every 1-2 weeks, until they can perform 30 minutes of light exercise five times a week. Then the intensity is raised if desired. [4] [5] [6]

The exercise can be any activity that can be titrated, such as walking, jogging, swimming, using exercise machines, and these may be mixed to add variety. Increasing the intensity can be more challenging than increasing duration, and a heart rate monitor may be employed to track intensity. If exercise exacerbates a patient's symptoms, they may be encouraged to pause the increases until symptoms become manageable again. [4] [5] In other cases, the patient is expected to continue fixed increases in activity regardless of the degree of post-exertional malaise they experience. [7]

Patients are told that if exercise provokes symptoms, it is a typical response to becoming more active rather than a pathological process that causes permanent damage. Adverse effects may be increased if the practitioner is unfamiliar with CFS or exercise is not ramped up appropriately. [4]

Model

The discredited cognitive-behvioral model that underlies graded exercise Cognitive-behavioral model of ME-CFS.jpg
The discredited cognitive-behvioral model that underlies graded exercise

GET is based on the discredited model that people with ME/CFS avoid exerting themselves due to fear of triggering symptoms such as pain and fatigue, which causes deconditioning and further worsening of symptoms. [2] [8] Excessive focus on symptoms and attributing illness to biological factors are also said perpetuate the illness. [8] [5]

This model lacks evidence, contradicts patient experience, and fails to account for the biological evidence that ME/CFS is a serious medical condition. [8] [9] [10] Further, mental health problems or deconditioning do not cause ME/CFS. [11] [12] [13]

Effectiveness

Graded exercise therapy is generally considered to be an ineffective, outdated standard of care that can worsen the condition. [2] GET does not enable patients to increase their activity levels (as objectively measured by actigraphy) [14] or return to work. [15]

Major public health bodies recommend against GET. The CDC stopped recommending GET in 2017, [16] and says that people with ME/CFS do not tolerate vigorous exercise. NICE's 2021 guidance for ME/CFS removed graded exercise, which was recommended in the previous 2007 version, [17] and cautions against "any programme that...uses fixed incremental increases in physical activity or exercise, for example, graded exercise therapy." [18] [7] According to NICE, studies of GET have been of poor or very poor quality.

Two regional departments of health, in New York state and Victoria, Australia, say GET is ineffective and potentially dangerous. [12] [11] The Mayo Clinic consensus recommendations for the treatment of ME/CFS also oppose GET. [2]

ME/CFS patient organizations strongly oppose GET because they disagree that mental health problems are a cause of their illness and because many patients anecdotally report harms due to GET. [8]

As of 2015, the Royal Australian College of General Practitioners still supported graded exercise for CFS. [4]

Research

Outcomes reported by the PACE trial PACE trial subjective outcomes.svg
Outcomes reported by the PACE trial

The available research into GET is of poor or very poor quality. [7] [2] These studies generally have limited tracking of adverse effects, [3] [2] employ outdated definitions of ME/CFS that do not require post-exertional malaise, [3] and rely on subjective self-reported outcome measures within unblinded trials, making them prone to placebo effects. [15]

The largest study on GET, the 2011 PACE trial, reported that GET and cognitive-behavioral therapy were safe and resulted in recovery for 22% of participants and improvement for 60%. There has since been considerable debate over the validity of the results. Outcome measures were modified mid-trial without a clear rationale. [19] When the data were reanalyzed utilising the original protocol, the rate of improvement was only 21%, and recovery was just 4%. [19] While trial participants reported subjective improvement, there was no clinically significant improvement in fitness according to the 6-minute walk test, an objective outcome. [15]

A 2022 review commissioned by the CDC concluded that weak evidence suggests that GET has "small to moderate" benefits, including reduced fatigue, decreased depression and anxiety, and better sleep. It said these results are of uncertain relevance to people with severe ME/CFS, a diagnosis according to modern criteria, or post-exertional malaise. According to the review, limited evidence suggests that GET is not harmful, but that reporting of harms was "suboptimal." [20]

A 2019 Cochrane review of 8 studies concluded that GET "probably" reduces fatigue but that evidence on long-term effectiveness and potential harms are very limited. The studies analyzed employed older definitions of CFS, so the effects on current patient cohorts may be different. [21] An independent analysis of the same studies reached the opposite conclusion based on the unreliability of subjective outcomes in unblinded trials, lack of objective improvements in physical fitness and employment, and insufficient tracking of adverse events. [15]

The ME Association asserts that GET causes a significant fraction of patients to get worse: 30% to 50% in self-reported patient questionnaires. [22] According to the Mayo Clinic Proceedings recommendations, 54% to 74% reported harm. [2]

Graded exercise therapy has also been tested against fatigue and post-exertional malaise in long COVID, but found ineffective. [23]

Related Research Articles

<span class="mw-page-title-main">Fatigue</span> Range of afflictions, usually associated with physical or mental weakness

Fatigue describes a state of tiredness, exhaustion or loss of energy.

<span class="mw-page-title-main">ME Association</span> UK charitable organization

The ME Association is a UK health charitable organization that provides information, advocacy, and services to persons and families affected by ME/CFS, and raises funds for research into ME/CFS. It has been reported to be one of the two largest UK charities for ME/CFS.

<span class="mw-page-title-main">Exercise intolerance</span> Medical condition

Exercise intolerance is a condition of inability or decreased ability to perform physical exercise at the normally expected level or duration for people of that age, size, sex, and muscle mass. It also includes experiences of unusually severe post-exercise pain, fatigue, nausea, vomiting or other negative effects. Exercise intolerance is not a disease or syndrome in and of itself, but can result from various disorders.

<span class="mw-page-title-main">History of ME/CFS</span> Aspect of medical history

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has a long history with an evolution in medical understanding, diagnoses and social perceptions.

Management of ME/CFS focusses on symptoms management, as no treatments that address the root cause of the illness are available. Pacing, or regulating one's activities to avoid triggering worse symptoms, is the most common management strategy for post-exertional malaise. Clinical management varies widely, with many patients receiving combinations of therapies.

<span class="mw-page-title-main">Controversies related to ME/CFS</span> Controversies and issues related to ME/CFS

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is an illness with a history of controversy. Although it is classified as an organic disease by a majority of researchers, it was historically assumed to be psychosocial, an opinion still held among many physicians. The pathophysiology of ME/CFS remains unclear, there exists many competing diagnostic criteria, and some proposed treatments are controversial. There is a lack of education and accurate information about the condition among a significant number of medical practitioners, which has led to substantiated accusations of patient neglect and harm.

<span class="mw-page-title-main">Clinical descriptions of ME/CFS</span> Case definitions of the illness

Clinical descriptions of ME/CFS vary. Different groups have produced sets of diagnostic criteria that share many similarities. The biggest differences between criteria are whether post-exertional malaise (PEM) is required, and the number of symptoms needed.

The Lightning Process (LP) is a three-day personal training programme developed and trademarked by British osteopath Phil Parker. It makes unsubstantiated claims to be beneficial for various conditions, including ME/CFS, depression and chronic pain.

David Sheffield Bell is an American physician who has done extensive research on the clinical aspects of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). He has also conducted evaluations and research in pediatric ME/CFS and written numerous articles about the condition.

Daniel Peterson is an American physician in private practice in the state of Nevada, and has been described as a "pioneer" in the treatment of Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). He graduated from the University of Rochester School of Medicine, Rochester, New York, in 1976 and was an intern and resident at the University of Utah Medical Center from 1976 to 1979. In 1979, he became a diplomate of the American Board of Internal Medicine. He is president of Sierra Internal Medicine of Incline Village, established in 1981.

<span class="mw-page-title-main">Myalgic encephalomyelitis/chronic fatigue syndrome</span> Chronic medical condition

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a disabling chronic illness. People with ME/CFS experience profound fatigue that does not go away with rest, sleep issues and problems with memory or concentration. Further common symptoms include dizziness, nausea and pain. The hallmark symptom is a worsening of the illness which starts hours to days after minor physical or mental activity. This "crash" can last from hours or days to several months.

Rosamund Vallings is a medical doctor, known as one of the leading authorities on Chronic Fatigue Syndrome (ME/CFS) in New Zealand.

<span class="mw-page-title-main">Post-exertional malaise</span> Worsening of symptoms with activity

Post-exertional malaise (PEM), sometimes referred to as post-exertional symptom exacerbation (PESE) or post-exertional neuroimmune exhaustion (PENE), is a worsening of symptoms that occurs after minimal exertion. It is the hallmark symptom of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and common in long COVID and fibromyalgia. PEM is often severe enough to be disabling, and is triggered by ordinary activities that healthy people tolerate. Typically, it begins 12–48 hours after the activity that triggers it, and lasts for days, but this is highly variable and may persist much longer. Management of PEM is symptom-based, and patients are recommended to pace their activities to avoid triggering PEM.

Idiopathic chronic fatigue (ICF) or chronic idiopathic fatigue or insufficient/idiopathic fatigue is a term used for cases of unexplained fatigue that have lasted at least six consecutive months and which do not meet the criteria for myalgic encephalomyelitis/chronic fatigue syndrome. Such fatigue is widely understood to have a profound effect on the lives of patients who experience it.

<span class="mw-page-title-main">2-day CPET</span> Medical test for post-exertional malaise

A 2-day CPET is a cardiopulmonary exercise test given on two successive days to measure the effect of post-exertional malaise (PEM) on a patient's ability to exercise. PEM is a cardinal symptom of myalgic encephalomyelitis/chronic fatigue syndrome and is common in long COVID as well.

Post-acute infection syndromes (PAISs) or post-infectious syndromes are medical conditions characterized by symptoms attributed to a prior infection. While it is commonly assumed that people either recover or die from infections, long-term symptoms—or sequelae—are a possible outcome as well. Examples include long COVID, Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and post-Ebola virus syndrome. Common symptoms include post-exertional malaise (PEM), severe fatigue, neurocognitive symptoms, flu-like symptoms, and pain. The pathology of most of these conditions is not understood and management is generally symptomatic.

Andrew Melvin Ramsay (1901–1990) was a British physician, who is known for his research and advocacy on myalgic encephalomyelitis (ME), a chronic disease causing muscle weakness and cognitive dysfunction. Ramsay worked as a consultant at the Royal Free Hospital in London during a mysterious 1955 disease outbreak of what later became known as ME. He studied the disease and similar outbreaks elsewhere. Work by Ramsay showed that although ME seldom caused death, the disease could be highly disabling.

Carmen Scheibenbogen is a German immunologist who is the acting director of the Institute for Medical Immunology of the Charité university hospital in Berlin. She specialises in hematology, oncology and immunology. She leads the Outpatient Clinic for Immunodeficiency and the Fatigue Centre at the Charité hospital. She is one of the few doctors specialised in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in Germany, and also researches long COVID.

The PACE trial was a large and controversial trial which compared the effects of cognitive behavioural therapy (CBT), graded exercise therapy (GET), adaptive pacing therapy, and specialist medical care for people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Chronotropic incompetence (CI) is the inability of heart rate to increase as expected in response to exercise. The condition can be defined in different ways and occurs in various diseases. Sufferers have a higher risk of cardiovascular disease and early death.

References

  1. ↑ "Myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS) - Treatment". nhs.uk. 2017-10-20. Retrieved 2023-01-20.
  2. 1 2 3 4 5 6 7 Bateman L, Bested AC, Bonilla HF, Chheda BV, Chu L, Curtin JM, et al. (November 2021). "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Essentials of Diagnosis and Management". Mayo Clinic Proceedings. 96 (11): 2861–2878. doi: 10.1016/j.mayocp.2021.07.004 . PMID   34454716. S2CID   237419583.
  3. 1 2 3 Diagnosis and Management of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Agency for Healthcare Research and Quality. 2016.
  4. 1 2 3 4 "Graded exercise therapy: chronic fatigue syndrome". Royal Australian College of General Practitioners. March 2015. Archived from the original on 2022-11-11.
  5. 1 2 3 Sharpe M, Chalder T, White PD (February 2022). "Evidence-Based Care for People with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis". Journal of General Internal Medicine. 37 (2): 449–452. doi:10.1007/s11606-021-07188-4. PMC   8811058 . PMID   34791590.
  6. ↑ Larun L, Brurberg KG, Odgaard-Jensen J, Price JR, et al. (Cochrane Common Mental Disorders Group) (October 2019). "Exercise therapy for chronic fatigue syndrome". The Cochrane Database of Systematic Reviews. 10 (10): CD003200. doi:10.1002/14651858.CD003200.pub8. PMC   6953363 . PMID   31577366.
  7. 1 2 3 "Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management | Guidance | NICE". www.nice.org.uk.
  8. 1 2 3 4 Geraghty K, Jason L, Sunnquist M, Tuller D, Blease C, Adeniji C (2019). "The 'cognitive behavioural model' of chronic fatigue syndrome: Critique of a flawed model". Health Psychology Open. 6 (1): 2055102919838907. doi:10.1177/2055102919838907. PMC   6482658 . PMID   31041108.
  9. ↑ Shepherd CB (August 2017). "PACE trial claims for recovery in myalgic encephalomyelitis/chronic fatigue syndrome - true or false? It's time for an independent review of the methodology and results". Journal of Health Psychology. 22 (9): 1187–1191. doi: 10.1177/1359105317703786 . PMID   28805522. S2CID   22307162.
  10. ↑ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) | CDC". www.cdc.gov. 2022-12-29. Retrieved 2023-03-05. (ME/CFS) is a serious, long-term illness...
  11. 1 2 Department of Health & Human Services. "Chronic fatigue syndrome (CFS)". www.betterhealth.vic.gov.au. Retrieved 2023-03-05. A person with ME/CFS should never be coaxed to push past their limit as this can be dangerous and cause long-term relapse.
  12. 1 2 "Myalgic Encephalomyelitis ("Chronic Fatigue Syndrome")". health.ny.gov. Retrieved 2023-03-05.
  13. ↑ Ghali A, Lacombe V, Ravaiau C, Delattre E, Ghali M, Urbanski G, Lavigne C (June 2023). "The relevance of pacing strategies in managing symptoms of post-COVID-19 syndrome". Journal of Translational Medicine. 21 (1): 375. doi: 10.1186/s12967-023-04229-w . PMC   10248991 . PMID   37291581. Nevertheless, a large number of studies demonstrated that deconditioning does not perpetuate or explain the symptoms in these patients.
  14. ↑ Vink M, Vink-Niese A (May 2022). "The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS". Healthcare. 10 (5): 898. doi: 10.3390/healthcare10050898 . PMC   9141828 . PMID   35628033.
  15. 1 2 3 4 Vink M, Vink-Niese F (2020-01-01). "Graded exercise therapy does not restore the ability to work in ME/CFS - Rethinking of a Cochrane review". Work. 66 (2): 283–308. doi: 10.3233/WOR-203174 . PMID   32568149. S2CID   219974354.
  16. ↑ Doucleff M (2017-10-02). "For People With Chronic Fatigue Syndrome, More Exercise Isn't Better". NPR . Retrieved 2023-03-05.
  17. ↑ Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy)—Diagnosis and management of CFS/ME in adults and children (PDF). National Institute for Clinical Excellence. 2007. p. 53. Archived from the original (PDF) on 2014-04-16.
  18. ↑ "Treatment of ME/CFS". Centers for Disease Control and Prevention . Retrieved November 19, 2019.
  19. 1 2 Wilshire CE, Kindlon T, Courtney R, Matthees A, Tuller D, Geraghty K, Levin B (March 2018). "Rethinking the treatment of chronic fatigue syndrome-a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT". BMC Psychology. 6 (1): 6. doi: 10.1186/s40359-018-0218-3 . PMC   5863477 . PMID   29562932.
  20. ↑ Management of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): An Updated Systematic Evidence Review (PDF). Centers for Disease Control and Prevention. 2022. pp. ii–iii, 23.
  21. ↑ Larun L, Brurberg KG, Odgaard-Jensen J, Price JR, et al. (Cochrane Common Mental Disorders Group) (October 2019). "Exercise therapy for chronic fatigue syndrome". The Cochrane Database of Systematic Reviews. 10 (10): CD003200. doi:10.1002/14651858.CD003200.pub8. PMC   6953363 . PMID   31577366.
  22. ↑ "ME Association position on graded exercise therapy (GET) | 11 May 2008 | The ME Association". meassociation.org.uk. 2008-05-11.
  23. ↑ Ghali A, Lacombe V, Ravaiau C, Delattre E, Ghali M, Urbanski G, Lavigne C (June 2023). "The relevance of pacing strategies in managing symptoms of post-COVID-19 syndrome". Journal of Translational Medicine. 21 (1): 375. doi: 10.1186/s12967-023-04229-w . PMC   10248991 . PMID   37291581.
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