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Table 2 Summary of data collection

From: Efficacy of a multi-component exercise programme and nutritional supplementation on musculoskeletal health in men treated with androgen deprivation therapy for prostate cancer (IMPACT): study protocol of a randomised controlled trial

Variables Data collection method Data collection points
Baseline 26 weeks 52 weeks
Primary outcome measures
 Areal bone mineral density DXA proximal femur and lumbar spine x x x
Secondary outcome measures
 Bone structure and strength pQCT scan at 4% and 66% radial and tibial site x x x
 Body composition DXA total body and regional lean mass, fat mass and % body fat x x x
pQCT 66% radial and tibial muscle cross-sectional area and muscle density x x x
 Muscle strength Chest press, leg press and seated row x x x
Grip strength x x x
 Functional capacity 30-s sit-to-stand x x x
Timed-up-and-go with cognitive task x x x
Four-square step test x x x
Berg balance scale x x x
Four-metre usual walk x x x
400-metre walk x x x
 Biochemistry and lipids Overnight, fasted serum and plasma collection x x x
 Inflammatory markers Overnight, fasted serum and plasma collection x x x
 Blood pressure Automated measurement x x x
 Cognitive function CogState Brief Battery computerised tests x x x
Rey Auditory Verbal Learning Test x x x
Trail Making Test (Part A and B) x x x
Digit Span Test x x x
National Adult Reading Test x   
 Health-related quality of life, fatigue and mood Functional Assessment of Cancer Therapy-Fatigue questionnaire x x x
Functional Assessment of Cancer Therapy-Prostate questionnaire x x x
Assessment of Quality of Life 8D questionnaire x x x
Geriatric Depression Scale questionnaire x x x
Depression Anxiety and Stress Scale questionnaire x x x
Additional measures
 Anthropometry Height, weight, Body Mass Index, waist and hip circumference x x x
 Habitual physical activity Community Healthy Activities Model Programme for Seniors physical activity questionnaire x x x
 Diet 24-h food recalls Collected every 13 weeks
 Additional questionnaire Demographic questionnaire x   
Clinical and lifestyle questionnaire x x x
Sun exposure habits and practices questionnaire x x x
Alcohol consumption questionnaire x x x
Medical questionnaire x x x
Medication questionnaire x x x
Falls questionnaire x x x
 Exercise programme adherence Calculated from monthly calendars collected every 4 weeks Collected every 4 weeks
 Supplement compliance Calculated from supplement returned at 26 and 52 weeks   x x
 Adverse events Calculated from monthly calendars collected every 4 weeks Collected every 4 weeks
  1. DXA dual-energy X-ray absorptiometry, pQCT peripheral quantitative computed tomography