Exercise vs. Usual Care in Stable Immune Mediated Neuropathy
Inflammatory immune mediated neuropathies (IN) are a heterogenous group of peripheral nerve disorders that affect around one to two people per 100,000. The conditions share an immune-mediated pathophysiological process but the clinical features may vary between conditions. Guillain-Barré syndrome (GBS) is an acute inflammatory polyneuropathy, characterised by rapidly progressive weakness, paralysis and sensory impairment reaching nadir within four weeks of onset such that the majority of patients are unable to walk independently when maximum weakness is reached. Prompt immunomodulatory treatment facilitates earlier recovery that is generally good; with the majority of patients regaining mobility within six to twelve months although residual problems are common and improvements may continue beyond this period. Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) shares many characteristics with GBS but presents a progressive or relapsing clinical course. There are a number of first-line, combination and supportive treatments available for CIDP, and whilst many patients experience long-term improvement, prognosis is variable and a significant proportion experience ongoing problems. A related condition, paraproteinaemic demyelinating neuropathy (PDN), is characterised by an IgM monoclonal gammopathy with, in about 50 % of cases, serum antibodies to myelin associated glycoprotein. PDN typically presents at an older age than GBS and CIDP, with most cases presenting in the sixth decade or later and symptoms appear similar to CIDP. Despite differences in the initial presentation and time course of GBS, CIDP and PDN, the symptoms experienced by patients and the impact of them on their daily lives are similar.
At least a third of people with IN experience long term activity limitation. Residual symptoms may still be present many years after recovery from GBS and CIDP. One ten year follow-up study showed that 14 % of participants with GBS still had moderate to severe disability and a further 50 % had more minor symptoms, suggesting that residual disability may be life-long. Fatigue is also a very common consequence of IN with between 40 – 80 % of people reporting it. It is often associated with reduced quality of life and greater activity limitation.
Persistent disability or fatigue experienced by people with IN adversely affects their working and daily lives, including family and social activities. Many people with IN need long-term informal care, often supplemented by support from health and social services. People with IN are high users of services and the personal suffering, as well as health and social care expenditure, increases as people live longer. Therefore, the potential for cost effective self-management programmes aimed at improving disability, mood, societal participation and quality of life should be evaluated.
There is currently no standardised care for patients with ongoing activity limitation and participation restriction as a result of IN. A systematic review of the efficacy of exercise on disability in IN concluded that the current evidence is of poor quality, although progressive resisted strengthening exercise may moderately improve muscle strength. However, observational studies show that supervised aerobic-cycling or unsupervised physiotherapist prescribed community based aerobic and strengthening exercise are associated with an improvement in function, fatigue and quality of life in people with IN. Further, one randomised controlled trial showed that high intensity multi-disciplinary rehabilitation that incorporated physiotherapy for strengthening, endurance and gait training was superior to low-intensity rehabilitation in improving disability in people with GBS several years after recovery. Therefore exercise may be beneficial in improving activity limitation after IN and tailoring the intervention for participants following physiotherapy assessment and incorporating patient preference for type and location of aerobic and strengthening exercise may be important.
A tailored approach to exercise prescription based on our pilot study has been developed for the current study in light of social cognition theory. The theory suggests that behaviour is determined by the interaction of current and previous behaviour, social, environmental and cognitive factors such as social support, observational learning or modelling, outcome expectations, self-efficacy, goal setting and self-regulation.
Thus, the current pragmatic randomised controlled trial (RCT) includes a process evaluation that is underpinned by the transtheoretical model (TTM) for behaviour change. The TTM has been shown to be useful in understanding and predicting behaviour change across a range of health behaviours including physical activity. The model proposes a temporal dimension of stages of change (SoC) to describe the sequential change in health related behaviours. The five stages of change are: pre-contemplation, contemplation, preparation, action and maintenance. The model assumes that the likelihood for behavioural change will be dependent on the stage of change at which individuals are currently at and that progress through the stages may be complex. Factors such as self-efficacy and decisional balance (the relative pros and cons of behaviour change) have been consistently shown to increase in a linear fashion alongside this progression through stages, suggesting various potential factors to be targeted for intervention.
In order to evaluate the potential role of home exercise for the management of IN, the current RCT will therefore assess the effectiveness, cost effectiveness and cost utility of a tHEP versus advice about exercise and usual care (UC) in a sample of adults with stable IN in the UK.
Principal Research Question. Is a tailored home exercise programme more effective in reducing disability (activity limitation) than advice about exercise and usual care in people with stable inflammatory immune-mediated neuropathy?
Primary hypothesis - a tailored home exercise programme will be more beneficial than advice about exercise and usual care in reducing activity limitation for people with IN.
Secondary Research Questions. What is the cost-effectiveness and cost utility of a tHEP compared with advice about exercise and usual care for people with IN?
Are the health beliefs of people with IN associated with their response to a tHEP versus advice about exercise and usual care?
What are participants' experiences of a tHEP and which factors influence uptake of and adherence to the programme?
Background
Inflammatory immune mediated neuropathies (IN) are a heterogenous group of peripheral nerve disorders that affect around one to two people per 100,000. The conditions share an immune-mediated pathophysiological process but the clinical features may vary between conditions. Guillain-Barré syndrome (GBS) is an acute inflammatory polyneuropathy, characterised by rapidly progressive weakness, paralysis and sensory impairment reaching nadir within four weeks of onset such that the majority of patients are unable to walk independently when maximum weakness is reached. Prompt immunomodulatory treatment facilitates earlier recovery that is generally good; with the majority of patients regaining mobility within six to twelve months although residual problems are common and improvements may continue beyond this period. Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) shares many characteristics with GBS but presents a progressive or relapsing clinical course. There are a number of first-line, combination and supportive treatments available for CIDP, and whilst many patients experience long-term improvement, prognosis is variable and a significant proportion experience ongoing problems. A related condition, paraproteinaemic demyelinating neuropathy (PDN), is characterised by an IgM monoclonal gammopathy with, in about 50 % of cases, serum antibodies to myelin associated glycoprotein. PDN typically presents at an older age than GBS and CIDP, with most cases presenting in the sixth decade or later and symptoms appear similar to CIDP. Despite differences in the initial presentation and time course of GBS, CIDP and PDN, the symptoms experienced by patients and the impact of them on their daily lives are similar.
At least a third of people with IN experience long term activity limitation. Residual symptoms may still be present many years after recovery from GBS and CIDP. One ten year follow-up study showed that 14 % of participants with GBS still had moderate to severe disability and a further 50 % had more minor symptoms, suggesting that residual disability may be life-long. Fatigue is also a very common consequence of IN with between 40 – 80 % of people reporting it. It is often associated with reduced quality of life and greater activity limitation.
Persistent disability or fatigue experienced by people with IN adversely affects their working and daily lives, including family and social activities. Many people with IN need long-term informal care, often supplemented by support from health and social services. People with IN are high users of services and the personal suffering, as well as health and social care expenditure, increases as people live longer. Therefore, the potential for cost effective self-management programmes aimed at improving disability, mood, societal participation and quality of life should be evaluated.
There is currently no standardised care for patients with ongoing activity limitation and participation restriction as a result of IN. A systematic review of the efficacy of exercise on disability in IN concluded that the current evidence is of poor quality, although progressive resisted strengthening exercise may moderately improve muscle strength. However, observational studies show that supervised aerobic-cycling or unsupervised physiotherapist prescribed community based aerobic and strengthening exercise are associated with an improvement in function, fatigue and quality of life in people with IN. Further, one randomised controlled trial showed that high intensity multi-disciplinary rehabilitation that incorporated physiotherapy for strengthening, endurance and gait training was superior to low-intensity rehabilitation in improving disability in people with GBS several years after recovery. Therefore exercise may be beneficial in improving activity limitation after IN and tailoring the intervention for participants following physiotherapy assessment and incorporating patient preference for type and location of aerobic and strengthening exercise may be important.
A tailored approach to exercise prescription based on our pilot study has been developed for the current study in light of social cognition theory. The theory suggests that behaviour is determined by the interaction of current and previous behaviour, social, environmental and cognitive factors such as social support, observational learning or modelling, outcome expectations, self-efficacy, goal setting and self-regulation.
Thus, the current pragmatic randomised controlled trial (RCT) includes a process evaluation that is underpinned by the transtheoretical model (TTM) for behaviour change. The TTM has been shown to be useful in understanding and predicting behaviour change across a range of health behaviours including physical activity. The model proposes a temporal dimension of stages of change (SoC) to describe the sequential change in health related behaviours. The five stages of change are: pre-contemplation, contemplation, preparation, action and maintenance. The model assumes that the likelihood for behavioural change will be dependent on the stage of change at which individuals are currently at and that progress through the stages may be complex. Factors such as self-efficacy and decisional balance (the relative pros and cons of behaviour change) have been consistently shown to increase in a linear fashion alongside this progression through stages, suggesting various potential factors to be targeted for intervention.
In order to evaluate the potential role of home exercise for the management of IN, the current RCT will therefore assess the effectiveness, cost effectiveness and cost utility of a tHEP versus advice about exercise and usual care (UC) in a sample of adults with stable IN in the UK.
Objectives and Hypotheses
Principal Research Question. Is a tailored home exercise programme more effective in reducing disability (activity limitation) than advice about exercise and usual care in people with stable inflammatory immune-mediated neuropathy?
Primary hypothesis - a tailored home exercise programme will be more beneficial than advice about exercise and usual care in reducing activity limitation for people with IN.
Secondary Research Questions. What is the cost-effectiveness and cost utility of a tHEP compared with advice about exercise and usual care for people with IN?
Are the health beliefs of people with IN associated with their response to a tHEP versus advice about exercise and usual care?
What are participants' experiences of a tHEP and which factors influence uptake of and adherence to the programme?
SHARE
