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Table 2 Eligibility criteria for the two pilot RCTs

From: Study protocol for two pilot randomised controlled trials aimed at increasing physical activity using electrically assisted bicycles to enhance prostate or breast cancer survival

 

Inclusion criteria

Exclusion criteria

CRANK-P

1. Men with D’Amico high-risk localised PCa (PSA > 20) or clinical stage ≥ cT2c or Gleason 8/9/10 [59] OR men with any N1 PCa OR men with metastatic PCa (stage M1)

2. Aged 18 years or over

3. Cleared for engaging in PA by the treating consultant

1. Engage in ≥ 150 min of MVPA per week as assessed by the Get Active Questionnaire [60]

2. Uncontrolled hypertension (systolic 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

CRANK-B

1. Women or men with early BC (i.e. stages 1 or 2) who have completed their primary BC treatment (i.e. surgery, systemic therapy and/or radiation therapy)

2. Aged 18 years or over

3. Cleared for engaging in PA by the treating surgeon

1. Engage in ≥ 150 min of MVPA per week as assessed by the Get Active Questionnaire [60]

2. Individuals with metastatic disease

3. Uncontrolled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 90 mmHg), for which the individual is not taking medication

4. 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

5. Use of a mobility aid preventing cycling

6. No previous experience riding a bicycle

7. Any other contra-indications to exercise

8. Are unable to read and communicate in English

  1. BC breast cancer, BP blood pressure, cT clinical T category, N degree to which cancer has spread to lymph nodes, M degree to which cancer has spread to other areas of the body, MVPA moderate-to-vigorous physical activity, NICE National Institute of Health and Care Excellence, PA physical activity, PCa prostate cancer, PSA prostate-specific antigen