Increasing physical activity levels using e-bikes to enhance prostate cancer survival
- Conditions
- Prostate cancerCancerMalignant neoplasm of prostate
- Registration Number
- ISRCTN42852156
- Lead Sponsor
- niversity of Bristol
- Brief Summary
2023 Protocol article in https://doi.org/10.1186/s40814-023-01293-3 (added 25/04/2023) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39151159/ The development of the CRANK intervention (added 19/08/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Men with high-risk localised prostate cancer (PSA >20 or clinical stage =cT2c or Gleason 8/9/10 (NICE Guidance definition)), OR men with locally advanced prostate cancer (in addition to the above, T3b and T4, N0 prostate cancer; and any T, N1 prostate cancer), OR men with metastatic prostate cancer (stage M1)
2. Aged 18 years or over
3. Cleared for engaging in physical activity by the treating consultant
For the instructor/coordinator interviews the inclusion criterion is that individuals have coordinated the CRANK project or delivered e-bike training to participants in the CRANK trial.
For healthcare professionals the inclusion criterion for participating in the interviews is that they have been involved in identifying and/or recruiting individuals for the CRANK-P trial.
1. Engage in =150 minutes of moderate-to-vigorous physical activity per week
2. Uncontrolled hypertension (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >90 mmHg), for which the individual is not taking medication
3. Comorbidities including myocardial infarction or stroke within the past 6 months or evidence of end-stage renal failure or liver disease, uncontrolled congestive heart failure or angina
4. Use of a mobility aid preventing cycling
5. No previous experience riding a bicycle
6. Any other contra-indications to exercise
7. Are unable to read and communicate in English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Recruitment, measured by the number of participants recruited by the end of the recruitment period<br>2. Retention rates, measured by retention of sample by the end of the intervention<br>3. Adherence to the intervention and data collection methods and the fidelity of intervention delivery measured through observation checklists during the study intervention period<br>4. Perceptions of the intervention for the deliverers, recruiters, and participants assessed with qualitative interviews after the study intervention<br>5. Safety or maintenance issues measured by recording incidents throughout the study intervention
- Secondary Outcome Measures
Name Time Method