Effect of physical exercise on adults with type 2 diabetes and low physical functioning

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN88437683
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Study Completion: 2021-12-22
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified