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Completed

NCT Number: NCT04011397

Feasibility of REHIT in NDH 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Accessing the NHS Trust Weight Management Service (Specialist Diabesity Clinic)
  • Aged between 18 and 65 years (inclusive)
  • Diagnosed as NDH (using standard criteria)
  • Male or female
  • Any ethnicity
  • Not currently partaking in a new structured exercise intervention
  • Considered low or medium risk for exercise using standard risk stratification [37]

Exclusion criteria

  • < 18 years and ≥ 66 years
  • Currently partaking in a new structured exercise intervention
  • Euglycaemic
  • Diagnosed with type 1 or type 2 diabetes; taking insulin; history of end stage liver or kidney disease, neuropathy or retinopathy; has hypertension that cannot be controlled by standard medication; has cardiovascular disease, or another contraindication to exercise
  • Considered high risk for exercise using standard risk stratification [37]
  • Unable to adequately understand verbal explanations and written information given in English (there were no funds available for translation services)

Treatment and study plan

Exercise intervention

Other

Exercise intervention (reduced-exertion, high-intensity interval training) delivered within an NHS setting. Consisted 10 min of cycle ergometry (inclusive of warm-up and cool down) including very brief maximal cycle sprints.

Usual Care

Behavioral

Members of a multi-disciplinary team including a consultant, diabetes specialist nurse, clinical psychologist, physiotherapist, and dietician worked together to promote patient self-management. Care was tailored to the specific circumstances of each patient after initial assessment and focussed on weight management, dietary education, behavioural therapy, and supported pharmacotherapy initiation as appropriate.

Primary outcomes

  1. Number of patients screened and considered eligible to take part in the study

    Time frame: 4-weeks

    Defined as the number of patients who had contact with the recruitment team and who were assessed for eligibility using inclusion and exclusion criteria.

  2. Reporting of adverse events

    Time frame: From first exposure to intervention to last (approx. 6-weeks)

    An adverse event was defined as any untoward occurrence that happened during the conduct of the study.

  3. Intervention adherence

    Time frame: From first exposure to intervention to last (approx. 6-weeks)

    Intervention adherence was calculated by summing the total number of participants and the target number of REHIT sessions (15 per participant) and comparing this against the actual completed sessions.

  4. Change in affective valence (pleasure-displeasure)

    Time frame: Change from first exposure to intervention to last (approx. 6 weeks)

    Pre-validated 'Feeling Scale' questionnaire which measure pleasure/displeasure responses during exercise. This is a single-item, 11-point, bipolar scale and ranges from - 5 'very bad' to + 5 'very good', with anchors designated for 0 (neutral) and all odd integers in-between. Lower scores are considered to be a worse outcome.

  5. Change in perceived exertion

    Time frame: Change from first exposure to intervention to last (approx. 6 weeks)

    Pre-validated 'Rating of Perceived Exertion' questionnaire which measures perceived effort during exercise. This is a 15-point scale and ranges from 6 'no exertion' to 20 'maximal exertion' with anchors designated for all the odd integers in-between. A higher score is considered a worse outcome.

  6. Change in enjoyment

    Time frame: Change from first exposure to intervention to last (approx. 6 weeks)

    Pre-validated 'Exercise Enjoyment Scale' (ESS) which measures enjoyment associated with exercise. This is a single-item, 7-point scale. Anchors are given at every integer, ranging from 1 'not at all' to 7 'extremely'. A lower score is a worse outcome.

Secondary outcomes

  1. Change in peak oxygen uptake (fitness test)

    Time frame: Change from baseline peak oxygen uptake at approx. 6-weeks

    Progressive cycle test to measure cardiovascular fitness (using gas analysis)

  2. Change in HBA1c (blood test)

    Time frame: Change from baseline HbA1c at approx. 6-weeks

    Widely used measure of blood glucose control

  3. Change in body composition

    Time frame: Change from baseline body composition at approx. 6-weeks

    Fat mass and fat-free mass estimated via bioelectrical impedance analysis

  4. Change in systolic and diastolic blood pressure

    Time frame: Change from baseline systolic and diastolic blood pressure at approx. 6-weeks

    Measured via automated digital blood pressure monitor

Sponsors and collaborators

Lead sponsor

University of Huddersfield

Other

Registry information

Official study title

Feasibility of Procedures for a Pragmatic Randomized Controlled Trial of Reduced Exertion, High-intensity Interval Training (REHIT) With Non-diabetic Hyperglycaemia Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2019
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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