ISRCTN88437683已完成未知
The effect of a multi-modal exercise intervention on patients with or at risk of type 2 diabetes and impaired physical functioning
niversity of Leicester0 个研究点目标入组 25 人开始时间: 2019年12月9日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 19/10/2022:
- •1. Males and females aged 40-70 years
- •2. BMI 25 to 40 kg/m2 (23 to 40 kg/m2 in individuals of south Asian ethnicity)
- •3. Patients with established T2DM (> 6 months since diagnosis) or with elevated blood glucose or HbA1c levels meeting criteria for pre-diabetes or at-risk status (impaired fasting glucose [fasting glucose = 5.5 mmol/l]), impaired glucose tolerance [2-hour post challenge glucose = 7.8 mmol/l] or HbA1C = 38.8 mmol/mol) reported within the preceding five years
- •4. Historical evidence or risk of functional limitation or frailty defined as at least one of:
- •4.1. Impaired physical function or frailty; SPPB score 1 to 10 (inclusive) recorded within the preceding 5 years
- •4.2. A coding of mild-to-moderate frailty based on the Electronic Frailty Index (eFI) within primary care
- •4.3. VO2peak = 18 ml/kg recorded within the preceding 5 years
- •4.4. SARC-F questionnaire score of 4 or more
- •4.5. Inactive – defined as = 7 500 steps per day as measured by a pedometer or undertaking less than 30 minutes of moderate or 15 minutes of vigorous physical activity per day as measured by an accelerometer or self-report. Objectively measured physical activity data will be included from within the preceding five years and self-reported data confirmed at baseline.
- •5. No severe hearing or vision deficits that would inhibit communication with the research team via videoconferencing
- •6. Willing to use a computer and videoconferencing software to communicate with a study team member during the assessments
- •7. Enough space to safely exercise
- •Previous participant inclusion criteria:
- •1. Males and females aged 40-70 years
- •2. BMI 25 to 40 kg/m2 (23 to 40 kg/m2 in individuals of south Asian ethnicity)
- •3. Patients with established T2DM (> 6 months since diagnosis)
- •4. SPPB 1 to 9
排除标准
- •1. Unable to consent
- •2. Persons unable to understand written and spoken English sufficiently to consent and participate fully in the study
- •3. Participating in other interventional studies
- •4. Recent history of stroke, myocardial infarction, unstable angina, congestive heart failure within 12 months
- •5. Uncontrolled hyperglycaemia (HbA1c > 10% - established through medical notes or confirmed through baseline blood sample results)
- •6. Stage 4 or 5 chronic kidney disease (eGFR < 30ml/min/1.73m2)
- •7. Chronic obstructive pulmonary disease
- •8. Heart failure
- •9. Terminal illness (life expectancy less than 1 year)
- •10. Patients with type 1 diabetes
- •11. Current smokers (having quit less than 1 year before entering the study)
- •12. Weight unstable within the past 6 months (> = 10 kg)
- •13. Unable to perform exercise testing/training
- •14. Taking part in regular (at least once a week) strenuous sport or activities (> 120 minutes self-reported exercise per week)
研究者
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