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 sites25 target enrollmentDecember 9, 2019

Overview

No summary available.

Registry

who.int

Start Date

December 9, 2019

End Date

December 22, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leicester

•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.

•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