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Table 1 Summary of Study Measures at Specified Time Points

From: Protocol for a phase III RCT and economic analysis of two exercise delivery methods in men with PC on ADT

Domain/Measure Time required T0: (Baseline) T1: (3 mo.) T2:6 mo. (End Int.) T3: 9 mo. (3 mo. f/u) T4:12 mo. (6 mo. f/u)
Quality of life
 FACT-P 4–5 min
 FACT-G 8–10 min
 FACT-F (co-primary) 5 min
Physical Fitness
 6MWT (co-primary) 6 min
 Sit-to-Stand Test 1 min
 Grip Strength 1 min
Biological Outcomesa < 5 min    
 Blood glucose       
 Cholesterol profile       
 PSA (safety)       
 Testosteronec       
 Haemoglobin (covariate)       
 HbA1c (covariate)       
Body Composition
 Bone mineral density 30 minb    
 Body compositiond 5 min    
Adherence       
 Accelerometer
 GLTEQ < 5 min
 Sessional attendancee      
Adherence Predictor Variables
 HCCQ 5 min     
 BREQ2 5 min    
 PNSF 5 min    
 PAB 5 min    
 Sedentary Behaviours 5 min    
Cost-Effectiveness
 Health questionnaire 5 min
 EQ-5D 5 min
Study Completion 5 min     
  1. a All biological measures are considered to be standard of care at baseline and 12 months. PSA is considered to be standard of care at all 3 time points. Blood glucose, cholesterol profile, and haemoglobin tests at 6 months are NOT standard of care
  2. b Can be done on separate day to reduce participant burden
  3. c Will only be measured in participants who are not on continuous ADT for the duration of the intervention
  4. d Includes BIA, waist circumference, and waist circumference: height ratio
  5. e Only for those in supervised groups (done weekly)
  6. Abbreviations: 6MWT 6 min walk test, BREQ2 Behavioral Regulations in Exercise Questionnaire – 2, EQ-5D EuroQol 5 dimensions of health scale, FACT-G Functional Assessment of Cancer Therapy General, FACT-F Fatigue subscale, FACT-P Prostate subscale, GLTEQ Godin Leisure Time Exercise Questionnaire, HbA1c glycated hemoglobin, HCCQ Health Care Climate Questionnaire, Int Intervention, PAB Planning, Attitudes, & Behaviour questionnaire, PSA prostate-specific antigen, PNSF Psychological Need Support and Frustration Scale – Relatedness Items