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Feasibility of REHIT in NDH Patients

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ClinicalTrials.gov Identifier: NCT04011397
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Haines, University of Huddersfield

Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • Screening and eligibility [ 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.
  • 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.
  • 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.
  • Change in affective valence (pleasure-displeasure) [ Time Frame: Change from first exposure to intervention to last (approx. 6 weeks) ]
    Pre-validated 'Feeling Scale' (FS) 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 in perceived exertion [ Time Frame: Change from first exposure to intervention to last (approx. 6 weeks) ]
    Pre-validated 'Rating of Perceived Exertion' (RPE) 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 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • 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)
  • Change in HBA1c (blood test) [ Time Frame: Change from baseline HbA1c at approx. 6-weeks ]
    Widely used measure of blood glucose control
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of REHIT in NDH Patients
Official Title  ICMJE Feasibility of Procedures for a Pragmatic Randomized Controlled Trial of Reduced Exertion, High-intensity Interval Training (REHIT) With Non-diabetic Hyperglycaemia Patients
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Feasibility study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes
  • Physical Activity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Intervention group
Exercise intervention (reduced-exertion, high-intensity interval training) alongside normal treatment. [low recruitment prohibited control arm]
Interventions:
  • Other: Exercise intervention
  • Behavioral: Usual care
Publications * Haines M. Feasibility of procedures for a randomised pilot study of reduced exertion, high-intensity interval training (REHIT) with non-diabetic hyperglycaemia patients. Pilot Feasibility Stud. 2020 Feb 19;6:28. doi: 10.1186/s40814-020-00571-8. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2019)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011397
Other Study ID Numbers  ICMJE UHuddersfield
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Responsible Party Matthew Haines, University of Huddersfield
Study Sponsor  ICMJE University of Huddersfield
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew Haines University of Huddersfield
PRS Account University of Huddersfield
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP