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Table 2 Schedule of assessments at baseline and post intervention

From: Mechanical suppression of osteolytic bone metastases in advanced breast cancer patients: a randomised controlled study protocol evaluating safety, feasibility and preliminary efficacy of exercise as a targeted medicine

Measures

Baseline

Post intervention

Tumour morphology (off-site)

 - MRI: T1-axial

X

X

Tumour biomarkers

 - Blood: HIF-1α, TGF-β

X

X

Anthropometry

 - Height (cm)

X

 

 - Weight (kg)

X

X

 - Waist circumference (cm)

X

X

 - Hip circumference (cm)

X

X

 - Femoral length (mm)

X

 

 - Tibial length (mm)

X

 

 - Body mass index (kg/m2)

X

X

 - Waist-to-hip ratio

X

X

Body composition

 - DXA: whole-body, spinal, hip

X

X

 - pQCT: femoral, tibial

X

X

Physical assessments

 - NeuroCom Balance Test

X

X

 - 1RM Strength Test (Leg Extension)

X

X

 - 400 m Walk Test

X

X

 - Timed Up and Go Test

X

X

Other biomarkers (off-site)

 - Blood: P1NP, ALP, CRP, fasting glucose and lipids

X

X

 - Urine: NTx

X

X

Questionnaires

 - Demographic and health history

X

 

 - Concomitant medications

X

X

 - Health-related quality of Life (SF-36)

X

X

 - Cancer-specific quality of life (EORTC: QLQ30, BR23)

X

X

 - Bone Pain (FACIT-BP)

X

X

 - Brief Symptom Index (BSI-18)

X

X

 - Insomnia Severity Index (ISI)

X

X

 - Godin Leisure-time Exercise

X

X

Exercise programme

 - Clinic exercise record sheet (prescribed vs. actual)

At each exercise session

 - Home exercise record sheet (prescribed vs. actual)

At each exercise session

 - Pre-session bone pain, muscle soreness and fatigue (VAS)

At each exercise session

 - Post-session rating of perceived exertion and tolerance (VAS)

At each exercise session

  1. Abbreviations: HIF-1α hypoxia-inducible factor 1-alpha, TGF-β transformation growth-like factor beta, DXA dual-energy x-ray absorptiometry, pQCT peripheral quantitative computed tomography, P1NP amino-terminal propeptide of type 1 procollagen, NTx amino-terminal collagen type-1 telopeptide, ALP alkaline phosphatase, CRP C-reactive protein, SF-36 Short Form-36, EORTC European Organisation for Research and Treatment of Cancer, FACIT-BP Functional Assessment of Chronic Illness Therapy-Bone Pain, VAS visual analogue scale