Skip to main content

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