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Developing objective assessment tools for measuring fatigue in clinical studies

 

Principal Investigator: Professor Wan-Fai Ng

 

The ultimate aim of the study is to identify candidate biobehavioural parameters that can be used as objective measurements of fatigue (physical and mental) in clinical studies.

The Study

Fatigue is a disabling symptom to many patients with chronic inflammatory conditions and older people. Fatigue is also a huge health and economic burden to the NHS and the society. There is currently no good treatment for fatigue. Although many drug companies recognise this large unmet need and market potential, they still hold back their investment to develop treatments for fatigue. An important reason for their reluctance to invest is because to obtain approval of new treatments for fatigue, the companies need to provide reliable, and ideally objective, data (that can stand up to the scrutiny of regulatory agencies such as the US Food and Drug Administration, European Medicines Agency) to show that the new drugs work.

Another important aspect of fatigue is that there are “physical” and “mental” components – the former referred to as muscular tiredness/weakness or reduced performance in physical activity in terms of intensity or duration, whereas mental fatigue is often referred to as reduced motivation and a feeling of cognitive impairment (e.g. forgetfulness, brain fog). Importantly, the underlying biology for physical and mental fatigue may be different.

This overall aim of this proposal is to identify reliable, objective measures of fatigue. More specifically, we will (i) investigate whether a wearable device collecting data on physical activity, sedentary behaviour, sleep and other physiological data (e.g. heart rate, skin temperature) are reliable objective measurements of physical fatigue and (ii) explore whether neuropsychological tests assessing alertness, reaction time, cognition and concentration are relaible objective measurements of mental fatigue.

Next steps

This study aims to generate pilot data to explore the use of (i) medical-grade physical activity monitor and biosensors coupled with advanced data analytic (collaborating with GSK) and statistical modelling to identify biobehavioural signature(s) of physical fatigue, and (ii) neuropsychological tests as surrogate objective measures of mental fatigue. The data will be used to prepare a full application to further evaluate and validate the utility of these tools as adjunct objective measures of fatigue in clinical studies. We have already discussed with the programme manager of the MRC Methodology Research Panel who has confirmed that such a proposal will be within the scope of the research programme. Other possible funding streams for the future development of the research include project grant fundings from the Arthritis Research UK and Innovate UK. Futhermore, we anticipate the methodology developed from this proposal will be transferrable to other fatigue-related chronic diseases and ageing syndromes, thus opening up additional funding opportunities to develop the research.


Project milestones

  • Obtain all regulatory approvals required for the study.
  • Study recruitment starts.
  • Complete study recruitment.
  • Complete data analysis and identify candidate biobehavioural markers as objective measures of physical and mental fatigue.
  • Submit funding applications to further the research, and to publish pilot data.