Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Current interventions as of 19/10/2022:
Participants will be randomised to either the exercise group or the control group with no exercise intervention. Participants in the exercise gr
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 = 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 19/10/2022: Physical function assessed by the incremental shuttle walk test (ISWT) and sit-to-stand 60 (STS 60) pre and post the 8-week intervention Previous primary outcome measure: Physical function assessed by the incremental shuttle walk test (ISWT) and the modified physical performance test (PPT) pre and post the 8-week intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/10/2022: 1. Lower body endurance assessed with the short physical performance battery (SPPB) test which involves balance, walking seed and ability to sit and stand from a chair. These assessments will be done pre and post the 8-week intervention 2. Postural stability ((pressure path area (mm2) and sway velocity (mm/s)) assessed with Fysiometer force plate pre and post the 8-week intervention. 3. Lower limbs muscle strength (isometric and isokinetic quadriceps strength) measured using a fixed dynamometer (Biodex) pre and post the 8-week intervention 4. Handgrip strength measured using a digital handheld dynamometer pre and post the 8-week intervention 5. Cross-sectional area of muscle, echo intensity (indication of intermuscular adipose tissue), fibre pennation angle, muscle, and subcutaneous fat thickness, and volume of lower limb muscles such as the rectus femoris (quadriceps) assessed with ultrasound imaging pre and post the 8-week intervention 6. Mechanical and viscoelastic (tone, elasticity and stiffness) characteristics of the quadriceps muscle assessed using myotonometery (MyotonPRO) pre and post the 8-week intervention 7. Bodyweight, height, waist circumference will be also measured both pre and post the 8-week intervention 8. Objectively measured habitual physical activity assessed with accelerometers throughout the duration of the intervention. Accelerometers will capture various measures, including time being sedentary, time in high-intensity exercise, etc 9. Dietary intake assessed with UK Diabetes and Diet Questionnaire (UKDDQ) both pre and post the 8-week intervention 10. Physical activity assessed using Recent Physical Activity Questionnaire (RPAQ) pre and post the 8-week intervention 11. Quality of life assessed through a number of hea | — |
Countries
England, United Kingdom
Outcome results
None listed