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Table 1 Overview Primary and Secondary outcome measures

From: Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue

Outcome measures

Instrument

A. Primary outcome measures

 

Cardiorespiratory fitness

Maximum exercise test (peakVO2 )

Muscular strength

30 s sit-to-stand test, maximal handgrip strength

Fatigue

Multidimensional Fatigue Inventory (MFI) [38] and the Fatigue Quality List (FQL) [40] questionnaires

B. Secondary outcome measures

 

Sociodemographic data

Age, education, marital status, living situation, comorbidities and life style variables (e.g. smoking)

Clinical data

 

Medical history

Date of diagnosis, subtype of disease, stage of disease, history of therapy

Disease status and treatment

Response to treatment, progression or relapse of disease and data on any additional treatment will be recorded from medical records

Adverse events

Medical records, reports of the sports physician and physical therapist

Physical tests

 

Physical examination

Height, weight, waist and hip circumferences, four skinfolds (biceps, triceps, suprailiacal and subscapular)

Body composition and bone mineral density

Dual Energy X-ray (DXA) scan

Questionnaires

 

Health-related quality of life

EORTC Quality of Life Questionnaire C30 (EORTC QLQ-C30) [43], EuroQol (EQ5D) [44], EORTC Chemotherapy-induced peripheral neuropathy module (QLQ-CIPN20) [45]

Physical activity

Physical Activity Scale for the Elderly (PASE) [46], Recordings of the Actitrainer accelerometer (Actigraph, Fort Walton Beach Florida, USA)

Mood disturbance

Hospital Anxiety and Depression Scale (HADS) [47, 48]

Functioning in daily life

Impact on Participation and Autonomy (IPA) [49]

Quality of Sleep

Pittsburgh Sleep Quality Index (PSQI) [50]

Return to work

Return to work questionnaire

Moderating variables

Questionnaire about pre-illness lifestyle, current attitudes toward and beliefs about exercise in general

Satisfaction with the intervention

Satisfaction questionnaire

Cost questionnaires

Cost dairies

Compliance with the exercise program

Self-report and objective measures (e.g. attendance, exercise logs, target intensity)