Feasibility of REHIT in NDH Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011397
• Other study ID #: UHuddersfield
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: January 2017

Study information

• Verified date: July 2019
• Source: University of Huddersfield
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Physical Activity

Intervention

Other:
• Exercise intervention
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.

Behavioral:
• Usual care
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Huddersfield

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients screened and considered eligible to take part in the study	Defined as the number of patients who had contact with the recruitment team and who were assessed for eligibility using inclusion and exclusion criteria.	4-weeks
Primary	Reporting of adverse events	An adverse event was defined as any untoward occurrence that happened during the conduct of the study.	From first exposure to intervention to last (approx. 6-weeks)
Primary	Intervention adherence	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.	From first exposure to intervention to last (approx. 6-weeks)
Primary	Change in affective valence (pleasure-displeasure)	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.	Change from first exposure to intervention to last (approx. 6 weeks)
Primary	Change in perceived exertion	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.	Change from first exposure to intervention to last (approx. 6 weeks)
Primary	Change in enjoyment	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.	Change from first exposure to intervention to last (approx. 6 weeks)
Secondary	Change in peak oxygen uptake (fitness test)	Progressive cycle test to measure cardiovascular fitness (using gas analysis)	Change from baseline peak oxygen uptake at approx. 6-weeks
Secondary	Change in HBA1c (blood test)	Widely used measure of blood glucose control	Change from baseline HbA1c at approx. 6-weeks
Secondary	Change in body composition	Fat mass and fat-free mass estimated via bioelectrical impedance analysis	Change from baseline body composition at approx. 6-weeks
Secondary	Change in systolic and diastolic blood pressure	Measured via automated digital blood pressure monitor	Change from baseline systolic and diastolic blood pressure at approx. 6-weeks