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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Wellcome Trust | OTHER |
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Primary research question: What is the effect of indoor rowing, under the ideal circumstances of a laboratory setting, on glucose control in adults with impaired glucose control?
Secondary research question: Is it possible to develop a full-scale study of the benefits of indoor rowing under the usual circumstances of a community setting?
Why? It is good practice to conduct a small pilot study before embarking on an expensive full-scale study.
What? Around 150 minutes of aerobic exercise and around 150 minutes of resistance exercise per week are necessary to meet prevailing recommendations for adults with impaired glucose control. Around 120 minutes of indoor rowing per week might be a less time-consuming alternative to prevailing recommendations because indoor rowing involves a combination of aerobic and resistance exercise.
Who? Twenty men and postmenopausal women aged 45-65 years with impaired glucose regulation, such as those with type 2 diabetes. Eligible volunteers will not have smoked in the last year, will not have exercised regularly in the last six months, and will not be taking any form of diabetes medication other than metformin. Eligible volunteers will have stable weight and a body mass index of 25-40.
Where and how? Before and after the exercise intervention, glucose control (postprandial blood glucose concentrations) will be assessed at Leicester Diabetes Centre and cardiac function (MRI) will be assessed at Glenfield Hospital. During the exercise intervention, participants will use an indoor rower three times per week for 12 weeks at Leicester Diabetes Centre. Participants will be taught how to row correctly and the duration and intensity will gradually increase. In order to inform the design of a full-scale trial, recruitment rate will be assessed, adherence will be monitored, and a third party will interview participants to find out if the intervention and assessments are feasible and acceptable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Experimental | All participants will receive usual care, including standard advice about diet and physical activity. In addition to usual care, participants will be asked to take part in a 12-week exercise programme. Participants will use an indoor rower (Concept 2, Model E) three times per week at Leicester Diabetes Centre. Each session will be supervised and the investigators will liaise with the participants to arrange convenient times to exercise, including mornings and evenings. The supervisors will teach the participants how to row correctly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indoor rowing | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Glucose control | Glucose control is indicated by postprandial glucose concentration, which will be assessed using a standardized meal test. | Changes from baseline (week 0) to post intervention (week 0 versus week 13 and week 0 versus week 14) |
| Change in Cardiac function | Cardiac function is indicated by diastolic strain rate, which will be assessed using magnetic resonance imaging. | Changes from baseline (week 0) to post intervention (week 13) |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Participants will be recruited via general practice databases and the investigators will calculate the proportion of eligible-and-invited individuals who agree to take part in the study. | Response rate to up to seven months of recruitment |
| Feasibility and acceptability as assessed by Semi-structured interviews |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Davies, MD | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicester Diabetes Centre | Leicester | LE5 4PW | United Kingdom |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The interview during the intervention will focus on recruitment literature, screening procedures, baseline assessments, and first impressions of indoor rowing. The interview after the intervention will focus on participants' experiences of indoor rowing, including their likes, dislikes and suggestions. Each interview will last around 30 to 60 minutes and will be led by an independent researcher not involved in the day-to-day conduct of the study. Some questions and topics will be predetermined, but conversations will be allowed to flow freely and change according to the interviewer's discretion. |
| Semi-structured interviews will be conducted during (week 5 or 6) and after (week 14) the intervention |
| Change in Sample size in a full-scale trial | Haemoglobin A1C is a longer-term marker of glucose control and may be an appropriate outcome for a full-scale trial. The investigators wish to use the sample standard deviation from this pilot study in haemoglobin A1C (and, possibly, other variables) to estimate the population standard deviation and, thus, the power of a full-scale trial. | Changes from baseline (week 0) to post intervention (week 13) |
| D004700 | Endocrine System Diseases |