Diabetes Clinical Trial
Official title:
Feasibility of Procedures for a Pragmatic Randomized Controlled Trial of Reduced Exertion, High-intensity Interval Training (REHIT) With Non-diabetic Hyperglycaemia Patients
The aim of this feasibility study was to describe and report data relevant to the acceptability of an exercise intervention (reduced-exertion, high-intensity interval training) in non-diabetic hyperglycaemia patients delivered in a National Health Service setting.
Background Physical activity and exercise interventions to improve health frequently bring
about intended effects under ideal circumstances but fail to demonstrate effectiveness when
translated to demonstrable benefits in real-world contexts. The aim of this feasibility study
was to describe and report data relevant to the acceptability of an exercise intervention
(reduced-exertion, high-intensity interval training) in non-diabetic hyperglycaemia (NDH)
patients delivered in a National Health Service (NHS) setting.
Individuals with NDH are an intermediary group of patients whose blood glucose levels are
higher than normal but not high enough to be diagnosed as diabetic. Such hyperglycaemic blood
glucose excursions in 'pre-diabetic' states contribute to the development of macro- and
micro-vascular disease risk and increases the risk of developing overt type 2 diabetes.
Interventions - such as increased physical activity - for individuals who are diagnostically
considered to have NDH are high priority, as they provide a substantial opportunity for
preventing future burden of diabetes on patients, the NHS, and the economy.
Evidence supporting the efficacy of exercise and physical activity as preventative or
therapeutic treatments for a range of chronic diseases, including obesity and diabetes, is
incontrovertible. However, exercise adherence is considered a significant issue. The most
commonly cited barrier to undertaking physical activity is perceived 'lack of time'.
Consequently, there has been a recent interest in high-intensity interval training (HIT)
which is characterised by brief periods of repeated very high-intensity exercise interspersed
with longer periods of recovery. More recently attempts have been made to modify HIT to make
it more time-efficient and tolerable. This approach is known as reduced-exertion,
high-intensity interval training (REHIT). In this study, issues of acceptability and
feasibility were considered when implementing a REHIT intervention into usual care within an
NHS setting.
Methods The purpose was to assess whether it would be appropriate to progress to a
larger-scale pragmatic trial, and to optimise the design and conduct of any such trial. The
intention was to recruit 40 participants from a single centre (specialist diabesity centre).
Patients were eligible to take part if they were diagnostically defined as non-diabetic
hyperglycaemic based on a glycated haemoglobin value of 42-46 mmol·mol. Methodological issues
were used to analyse problems that arose.
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