DiabetesNCT04011397
Feasibility of REHIT in NDH Patients
A study testing Exercise intervention in people with Diabetes and Physical Activity, run by University of Huddersfield.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Physical Activity
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- < 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)
About this study
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.
Read the 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.
- Conditions
- Diabetes, Physical Activity
- Being tested
- Exercise intervention, Usual care
- Keywords
- Diabetes, Exercise, Feasibility, HbA1c, Interval training
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 careBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Exercise intervention (reduced-exertion, high-intensity interval training) alongside normal treatment. [low recruitment prohibited control arm] Receives: Other: Exercise intervention; Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-weeks
Reporting of adverse events
An adverse event was defined as any untoward occurrence that happened during the conduct of the study.
Measured: From first exposure to intervention to last (approx. 6-weeks)
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.
Measured: From first exposure to intervention to last (approx. 6-weeks)
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.
Measured: Change from first exposure to intervention to last (approx. 6 weeks)
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.
Measured: Change from first exposure to intervention to last (approx. 6 weeks)
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.
Measured: Change from first exposure to intervention to last (approx. 6 weeks)
Secondary outcomes (4)
Change in peak oxygen uptake (fitness test)
Progressive cycle test to measure cardiovascular fitness (using gas analysis)
Measured: Change from baseline peak oxygen uptake at approx. 6-weeks
Change in HBA1c (blood test)
Widely used measure of blood glucose control
Measured: Change from baseline HbA1c at approx. 6-weeks
Change in body composition
Fat mass and fat-free mass estimated via bioelectrical impedance analysis
Measured: Change from baseline body composition at approx. 6-weeks
Change in systolic and diastolic blood pressure
Measured via automated digital blood pressure monitor
Measured: Change from baseline systolic and diastolic blood pressure at approx. 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study startMar 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Huddersfield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Haines, University of Huddersfield
- Investigators
- Matthew Haines, Principal investigator, University of Huddersfield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011397
- Sponsor's protocol ID
- UHuddersfield
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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.
PubMed 32099663
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Procedures for a Pragmatic Randomized Controlled Trial of Reduced Exertion, High-intensity Interval Training (REHIT) With Non-diabetic Hyperglycaemia Patients
- ClinicalTrials.gov ID
- NCT04011397
- Acronym / sponsor ID
- UHuddersfield
- Conditions
- Diabetes, Physical Activity
- Keywords
- Diabetes, Exercise, Feasibility, HbA1c, Interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of HuddersfieldUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Exercise intervention, Behavioral: Usual careExercise intervention (reduced-exertion, high-intensity interval training) alongside normal treatment. [low recruitment prohibited control arm] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- < 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionExercise 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. | Other | Intervention group |
| Usual careMembers 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. | Behavioural | Intervention group |
Primary outcome
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.
4 secondary outcomes
Change in peak oxygen uptake (fitness test)
Time frame: Change from baseline peak oxygen uptake at approx. 6-weeks
Change in HBA1c (blood test)
Time frame: Change from baseline HbA1c at approx. 6-weeks
Change in body composition
Time frame: Change from baseline body composition at approx. 6-weeks
Change in systolic and diastolic blood pressure
Time frame: Change from baseline systolic and diastolic blood pressure at approx. 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Derived from this study: PubMed 32099663Haines 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.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Haines principal investigator
University of Huddersfield
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Diabetes and Physical Activity, run by University of Huddersfield.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients screened and considered eligible to take part in the study (time frame: 4-weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.