Health benefits of a novel exercise intervention in Type 2 diabetes
| ISRCTN | ISRCTN02750650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02750650 |
| Secondary identifying numbers | 15666 |
- Submission date
- 18/11/2013
- Registration date
- 18/11/2013
- Last edited
- 11/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Although exercise is considered one of the three cornerstones of diabetes care programmes (together with diet and medication), the majority of individuals with type 2 diabetes do not achieve the minimum recommended levels of physical activity. One of the key barriers to exercise appears to be lack of time. We have recently shown that a novel exercise intervention requiring 80% less time than current physical activity recommendations is effective at improving insulin sensitivity in inactive men. This study compares the effectiveness of the interventions at improving blood sugar regulation, their effects on various other health measures (aerobic fitness, blood pressure, blood lipid profile), and views on the two exercise interventions (through measures of enjoyment and rating of perceived exertion).
Who can participate?
Men aged 40-60 who have been diagnosed with type 2 diabetes at least 6 months before entering the study
What does the study involve?
Participation involves following two 8-week supervised exercise interventions, spaced at least 6 weeks apart. Participants are randomly allocated to take part in either the new high-intensity interval training programme (cycling) or the currently recommended physical activity intervention (moderate intensity walking), then after a 6-week break the participants swap and take part in the other intervention. Before and after each intervention a range of health measurements will be taken to establish the effects of the interventions.
What are the possible benefits and risks of participating?
Positive results from this study will provide individuals with type 2 diabetes with an alternative means to manage their condition. There are no major risks involved with the study. However, blood samples will be taken and this may be associated with some discomfort or bruising. Only trained staff will perform this procedure and they will make every effort to minimise discomfort. Furthermore, the exercise sessions may be tiring, and as with all physical exercise there is a small inherent risk of physical injury. However, the exercise sessions are short and the risk of injury is low. Finally, there is a small risk of adverse cardiac events when performing high intensity exercise, but we will check for signs of undiagnosed heart disease before you start the exercise programmes. All research staff involved in this study are first-aid trained, and our labs are equipped with a defibrillator as standard.
Where is the study run from?
University of Bath (UK)
When is the study starting and how long is it expected to run for?
January 2014 to June 2015
Who is funding the study?
Diabetes UK
Who is the main contact?
Dr Niels Vollaard
n.vollaard@bath.ac.uk
Contact information
Scientific
Department for Health
Eastwood 22/23
The Avenue, Claverton Down
Bath
BA2 7AY
United Kingdom
| N.Vollaard@bath.ac.uk |
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A comparison of the effects of reduced-exertion high-intensity interval training and moderate/vigorous intensity walking on glycaemic control in Type 2 diabetes |
| Study objectives | Whether the high-intensity interval training programme will result in equivalent (or better) improvements in glycaemic control compared to current physical activity recommendations. The primary aim of the proposed study is to profile the impact of the highly time-efficient REHIT exercise intervention on glycaemic control in individuals with Type 2 diabetes, in comparison to current physical activity recommendations. |
| Ethics approval(s) | NRES Committee South West - Frenchay, 05/12/2013, ref: 13/SW/0298 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | 21 men with T2D will perform two 8-week exercise interventions in a counterbalanced crossover design, separated by =6 weeks. Before and three days after each 6-week intervention all participants will undergo a testing day to determine changes in glycaemic control and other health markers. Training-induced changes in health markers will be compared between the two interventions. One of the interventions will involve a time-efficient high-intensity interval training programme, whereas the control intervention will be based on current physical activity recommendations and involve moderate intensity walking. REHIT training: the REHIT intervention will involve three 10-min exercise sessions per week, consisting of unloaded cycling interspersed with two cycle-sprints against a resistance equivalent to 5% of body weight as previously described by Metcalfe et al. (2012). Sprints will last 10 s in weeks 1 and 2, 15 s in weeks 3 and 4, and 20 s in weeks 5-8. Walking intervention: the walking intervention will be based on guidelines provided by the American College of Sports Medicine and the American Diabetes Association, and involve five 30-min walking sessions per week, at an intensity corresponding to 40% of VO2max in weeks 1 and 2, 50% of VO2max in weeks 3 and 4, and 60% of VO2max in weeks 5-8. Follow Up Length: 6 month(s) Study Entry : Single Randomisation only |
| Intervention type | Behavioural |
| Primary outcome measure | Glycaemic control; timepoint(s): pre and post both interventions |
| Secondary outcome measures | 1. Aerobic fitness; timepoint(s): pre and post both interventions 2. Body composition; timepoint(s): pre and post both interventions |
| Overall study start date | 01/01/2014 |
| Completion date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Planned Sample Size: 21; UK Sample Size: 21; Description: We aim to recruit 21 men with type 2 diabetes. |
| Key inclusion criteria | 1. Men aged ≥40 years and ≤60 years 2. Diagnosed with Type 2 diabetes according to WHO criteria at least 6 months prior to entering the study: fasting plasma glucose ≥ 7.0 mmol/l (126 mg/dl) - OR 2-hour plasma glucose sample in a standard OGTT of ≥11.1 mmol/l (200 mg/dl) |
| Key exclusion criteria | 1. Insulin therapy 2. Use of sulphonylureas 3. Use of more than two anti-diabetic drugs 4. Use of β-blockers 5. Use of inhaled steroids (e.g., for asthma) 6. Any cardiovascular condition with the exception of well-controlled uncomplicated hypertension treated with no more than two drugs (either an ACE, ARB, calcium channel blocker or diuretic) 7. Cerebrovascular disease including previous stroke or aneurysm 8. History of exercise-induced asthma 9. History of Type 1 diabetes mellitus or a history of ketoacidosis 10. History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant) 11. Any prior history of malignancy with the exception of: 11.1. Basal cell carcinoma of the skin 11.2. Squamous cell carcinoma of the skin that has been recurrence-free for 5 years 11.3. Other malignancies (regardless of site) that have been recurrence-free for 5-10 years 12. BMI >35 kg/m2 13. Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg after at least a 5-minute seated rest at the screening visit) 14. A clinically significant ECG abnormality at the screening visit which in the opinion of the investigators exposes the subject to risk by enrolling in the trial 15. Overt contraindications to exercise as determined with a normal resting ECG 16. Yes to any questions on a standard physical activity readiness questionnaire (PAR-Q) 17. Classification as highly physically active on the International Physical Activity Questionnaire (IPAQ) 18. Current participation in another research study 19. Inability to fully understand the verbal and written descriptions of the study in English, and the instructions provided during the study |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 01/06/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BA2 7AY
United Kingdom
Sponsor information
University/education
The Avenue
Claverton Down
Bath
BA2 7AY
England
United Kingdom
"ROR" |
https://ror.org/002h8g185 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/08/2017: Publication reference added.
