Outcome measures | Instrument |
---|---|
Primary | Â |
Cardiorespiratory fitness | Maximal exercise test. |
Muscle strength | Maximum handgrip strength and 30 seconds chair stands test. |
Fatigue | Multidimensional Fatigue Inventory (MFI) [50] and the Fatigue Quality List (FQL) [51] questionnaires. |
Secondary | Â |
Body composition and bone mineral density | DXA-scans3 [55, 56] and physical examination; height, weight, waist and hip circumferences, four skinfolds (biceps, triceps, suprailiacal and subscapular). |
Objective level of physical activity | Recordings of the Actitrainer accelerometer (Actigraph, Fort Walton Beach, USA). |
Health-related quality of life | EORTC Quality of Life Questionnaire C30 (EORTC QLQ-C30) [57], the EORTC Myeloma Module (QLQ-MY20) [58]. |
Neuropathy3 | EORTC Chemotherapy-induced peripheral neuropathy module (QLQ-CIPN20) [59]. |
Self reported physical activity | PASE questionnaire [60]. |
Mood disturbance | Hospital Anxiety and Depression Scale (HADS) questionnaire [61, 62]. |
Functioning in daily life | Impact on Participation and Autonomy (IPA) questionnaire [63]. |
Return to work | Return to work questionnaire. |
Cost questionnaires4 | EuroQol (EQ5D) [54] and cost questionnaires. |
Other | Â |
Sociodemographic data1 | Age, education, marital status, living situation, co-morbidities and life style variables (e.g. smoking). |
Medical history1 | Date of diagnosis, subtype of disease, stage of disease, history of therapy will be recorded from medical records. |
Disease status and treatment | Blood levels (incl. platelet and erythrocyte count), response to treatment, progression or relapse of disease and data on any additional treatment will be recorded from medical records. |
Comorbidity | A questionnaire and at T = 0 a sports physician will examine comorbidities that might interfere with the intervention program or influence study outcome. |
Adverse events | Medical records, reports of the sports physician and physiotherapist. |
Potential predictors of compliance | Questionnaire about pre-illness lifestyle, current attitudes toward and beliefs about exercise in general. |
Satisfaction with the intervention2 | Satisfaction questionnaire; intervention arm only. |
Compliance with the exercise program2 | Self-report and objective measures (e.g. attendance, exercise logs, target intensity); intervention arm only. |