E-bikes for individuals with type 2 diabetes

Not Applicable

Completed

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

• Registration Number: ISRCTN67421464
• Lead Sponsor: niversity of Bristol

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31788322 protocol (added 05/12/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37072802/ results (added 26/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-03
• Study Completion: 2020-03-01
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Clinical diagnosis of type 2 diabetes mellitus
2. Aged 30 to 70 years
3. Do not currently engage in 150-minutes of moderate-to-vigorous physical activity per week (assessed by the Get Active Questionnaire; CSEP 2017)
4. Cleared for engaging in physical activity by their General Practitioner
5. Can read, write and speak English

Exclusion Criteria

1. Currently taking exogenous insulin
2. Uncontrolled hypertension (systolic blood pressure (BP) > 160 mmHg and/or diastolic BP > 90 mmHg), for which the individual is not taking medication
3. Myocardial infarction or stroke within the past six months or evidence of end-stage renal failure or liver disease
4. Any other contra-indications to exercise

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility of the intervention and research methods assessed through measurement of:<br>1. Recruitment to the trial<br>2. Willingness of participants to be randomized <br>3. Retention rates<br>4. Adherence to the intervention and research procedure methods including data collection<br>5. Intervention fidelity <br>6. Participants experiences of being part of the trial<br>These outcomes will be measured at the end of the study. Recruitment, willingness to be randomized, retention rates and intervention fidelity will be descriptively described. Adherence to intervention and research procedures will be measured through calculating the number of participants who complete each research procedure. Participants experiences of being part of the trial will be assessed through analysis of data collected through qualitative interviews conducted after post-intervention testing.