Feasibility of procedures for a randomised pilot study of reduced exertion, high-intensity interval training (REHIT) with non-diabetic hyperglycaemia patients

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Abstract

Background
Physical activity and exercise interventions to improve health frequently bring about intended effects under ideal circumstances but often fail to demonstrate benefits in real-world contexts. The aim of this study was to describe the feasibility of an exercise intervention (reduced-exertion, high-intensity interval training) in non-diabetic hyperglycaemia patients delivered in a National Health Service setting to assess whether it would be appropriate to progress to a future large-scale study.
Methods
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 (HbA1c) value of 42–46 mmol·mol. Study procedures including recruitment, occurrence of adverse events, intervention acceptability, and intervention adherence were used to assess feasibility.
Results
Key criteria for progression to a larger study were not met. The study revealed several issues including patient eligibility, challenges to recruitment, patient consent, and poor clinician engagement. Furthermore, despite the simplicity and convenience of using HbA1c to screen for diabetes risk, the process of accurately screening and case finding eligible patients was problematic. The small sample recruited for this trial (n = 6) also limits interpretation of data, thus it is not possible to estimate variability of intended outcomes to use in a formal sample size calculation for a full-scale trial. Some aspects of the intervention worked well. The acceptability of the exercise intervention and outcome measures met progression criteria thresholds and adherence was very high, with 97% of exercise sessions completed for participants that finished the study.
Conclusions
Given the issues, the trial is not feasible in its current form. Yet, this preparatory stage of trial design pre-empted problems with the intervention that could be changed to optimise the design and conduct of future studies. Solutions to the issues identified in this study revolve around using a dedicated local recruiter with a strong relationship among the healthcare team and patients, using participant incentives to take part, and allowing for a longer recruitment period.
Original languageEnglish
JournalPilot and Feasibility Studies
Publication statusAccepted/In press - 7 Feb 2020

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Hyperglycemia
Exercise
Patient Care Team
Glycosylated Hemoglobin A
National Health Programs
Sample Size
Patient Selection
Motivation
Outcome Assessment (Health Care)
High-Intensity Interval Training
Health

Cite this

@article{bdf2a9504cc24f1f8e956792916de6cb,
title = "Feasibility of procedures for a randomised pilot study of reduced exertion, high-intensity interval training (REHIT) with non-diabetic hyperglycaemia patients",
abstract = "BackgroundPhysical activity and exercise interventions to improve health frequently bring about intended effects under ideal circumstances but often fail to demonstrate benefits in real-world contexts. The aim of this study was to describe the feasibility of an exercise intervention (reduced-exertion, high-intensity interval training) in non-diabetic hyperglycaemia patients delivered in a National Health Service setting to assess whether it would be appropriate to progress to a future large-scale study.MethodsThe 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 (HbA1c) value of 42–46 mmol·mol. Study procedures including recruitment, occurrence of adverse events, intervention acceptability, and intervention adherence were used to assess feasibility. ResultsKey criteria for progression to a larger study were not met. The study revealed several issues including patient eligibility, challenges to recruitment, patient consent, and poor clinician engagement. Furthermore, despite the simplicity and convenience of using HbA1c to screen for diabetes risk, the process of accurately screening and case finding eligible patients was problematic. The small sample recruited for this trial (n = 6) also limits interpretation of data, thus it is not possible to estimate variability of intended outcomes to use in a formal sample size calculation for a full-scale trial. Some aspects of the intervention worked well. The acceptability of the exercise intervention and outcome measures met progression criteria thresholds and adherence was very high, with 97{\%} of exercise sessions completed for participants that finished the study. ConclusionsGiven the issues, the trial is not feasible in its current form. Yet, this preparatory stage of trial design pre-empted problems with the intervention that could be changed to optimise the design and conduct of future studies. Solutions to the issues identified in this study revolve around using a dedicated local recruiter with a strong relationship among the healthcare team and patients, using participant incentives to take part, and allowing for a longer recruitment period.",
keywords = "diabetes, exercise, feasibility, HbA1c, interval-training",
author = "Matthew Haines",
year = "2020",
month = "2",
day = "7",
language = "English",
journal = "Pilot and Feasibility Studies",
issn = "2055-5784",
publisher = "BioMed Central Ltd.",

}

TY - JOUR

T1 - Feasibility of procedures for a randomised pilot study of reduced exertion, high-intensity interval training (REHIT) with non-diabetic hyperglycaemia patients

AU - Haines, Matthew

PY - 2020/2/7

Y1 - 2020/2/7

N2 - BackgroundPhysical activity and exercise interventions to improve health frequently bring about intended effects under ideal circumstances but often fail to demonstrate benefits in real-world contexts. The aim of this study was to describe the feasibility of an exercise intervention (reduced-exertion, high-intensity interval training) in non-diabetic hyperglycaemia patients delivered in a National Health Service setting to assess whether it would be appropriate to progress to a future large-scale study.MethodsThe 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 (HbA1c) value of 42–46 mmol·mol. Study procedures including recruitment, occurrence of adverse events, intervention acceptability, and intervention adherence were used to assess feasibility. ResultsKey criteria for progression to a larger study were not met. The study revealed several issues including patient eligibility, challenges to recruitment, patient consent, and poor clinician engagement. Furthermore, despite the simplicity and convenience of using HbA1c to screen for diabetes risk, the process of accurately screening and case finding eligible patients was problematic. The small sample recruited for this trial (n = 6) also limits interpretation of data, thus it is not possible to estimate variability of intended outcomes to use in a formal sample size calculation for a full-scale trial. Some aspects of the intervention worked well. The acceptability of the exercise intervention and outcome measures met progression criteria thresholds and adherence was very high, with 97% of exercise sessions completed for participants that finished the study. ConclusionsGiven the issues, the trial is not feasible in its current form. Yet, this preparatory stage of trial design pre-empted problems with the intervention that could be changed to optimise the design and conduct of future studies. Solutions to the issues identified in this study revolve around using a dedicated local recruiter with a strong relationship among the healthcare team and patients, using participant incentives to take part, and allowing for a longer recruitment period.

AB - BackgroundPhysical activity and exercise interventions to improve health frequently bring about intended effects under ideal circumstances but often fail to demonstrate benefits in real-world contexts. The aim of this study was to describe the feasibility of an exercise intervention (reduced-exertion, high-intensity interval training) in non-diabetic hyperglycaemia patients delivered in a National Health Service setting to assess whether it would be appropriate to progress to a future large-scale study.MethodsThe 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 (HbA1c) value of 42–46 mmol·mol. Study procedures including recruitment, occurrence of adverse events, intervention acceptability, and intervention adherence were used to assess feasibility. ResultsKey criteria for progression to a larger study were not met. The study revealed several issues including patient eligibility, challenges to recruitment, patient consent, and poor clinician engagement. Furthermore, despite the simplicity and convenience of using HbA1c to screen for diabetes risk, the process of accurately screening and case finding eligible patients was problematic. The small sample recruited for this trial (n = 6) also limits interpretation of data, thus it is not possible to estimate variability of intended outcomes to use in a formal sample size calculation for a full-scale trial. Some aspects of the intervention worked well. The acceptability of the exercise intervention and outcome measures met progression criteria thresholds and adherence was very high, with 97% of exercise sessions completed for participants that finished the study. ConclusionsGiven the issues, the trial is not feasible in its current form. Yet, this preparatory stage of trial design pre-empted problems with the intervention that could be changed to optimise the design and conduct of future studies. Solutions to the issues identified in this study revolve around using a dedicated local recruiter with a strong relationship among the healthcare team and patients, using participant incentives to take part, and allowing for a longer recruitment period.

KW - diabetes

KW - exercise

KW - feasibility

KW - HbA1c

KW - interval-training

M3 - Article

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

SN - 2055-5784

ER -