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Table 2 Outcome measures and tests

From: Effect of aerobic exercise training and cognitive behavioural therapy on reduction of chronic fatigue in patients with facioscapulohumeral dystrophy: protocol of the FACTS-2-FSHD trial

Primary outcome measure  
Fatigue severity Checklist Individual Strength (CIS subscale fatigue) [30]
Secondary outcome measures  
ICF: bodily funtions  
Aerobic exercise tolerance Maximal oxygen consumption (VO2 max) using the Astrand protocol[31]
  6-minutes walking test [32]
  Resting heart rate
Muscle strength of quadriceps, Quantitative Muscle Assessment using fixed myometry testing
hamstrings and tibialis anterior system (QMA) [18]
Cardiovascular risk factors Blood pressure*
  Abdominal circumference
  Weight/Body Mass Index (BMI)
  Percentage body fat
  Visual Analogue Scale (VAS) [33]
Pain Daily Observed Pain (during a period of 2 weeks) [27, 34]
Psychological well-being and Brief Symptom Inventory (BSI) [35]
sleeping pattern  
Metabolic biomarkers Blood and urine analyses for creatine, glucose, creatine kinase,
  sodium, potassium, calcium, phosphorus, ureum, ALAT, ASAT,
  gamma-GT, bilirubine, AF and LDH***
Structural and metabolic muscle characteristics T1 MRI, T2 MRI, 31P and 1H MRS analysis of muscle specific creatine, extramyocellular lipids, intramyocellular lipids, levels and phosphometabolites in thigh muscles; ultrasound of thigh muscles
ICF: activities  
Physical activity in daily life Actometer, a motion sensing device (during a period of 2 weeks)
  [26, 27]
  Daily Observed Spontaneous physical activity (during a period of 2 weeks) [27, 34].
  Checklist Individual Strength (CIS subscale physical activity) [30]
Self perceived functional status Sickness Impact Profile (SIP subscales mobility control and mobility range, social behavior) [36]
ICF: participation  
Limitations in participation and autonomy Quality of life Fall incidence The Impact on Participation and Autonomy Questionnaire (IPAQ)[37]
  36-Item Short-Form Health Survey (SF-36) [38]
  Telephone computer (weekly calls)**
ICF: personal factors  
Coping Coping Inventory for Stressful Situation (CISS) [30]
  ALCOS-16 [39]
Illness cognitions Ziekte cognitie lijst (ZCL) [40]
Concentration problems Checklist Individual Strength (CIS subscale concentration) [21]
Motivation Checklist Individual Strength (CIS subscale motivation)[21]
ICF: environmental factors  
Caregiver strain Caregiver Strain Index of partner/caregiver (CSI) [41]
Experienced fatigue of patient Checklist Individual Strength (CIS subscale fatigue, filled in by
from perspective of relative. relative about patient) [21]
Experienced fatigue of partner. Checklist Individual Strength (CIS subscale fatigue, filled in by relative about him/herself) [21]
Social support Sociale steunlijst-subschaal discrepantie (SSL-D verkort) [42]
Coping of partner Coping Inventory for Stressful Situations (CISS) [30]
  1. *Measured only at inclusion. **Participants will be called weekly throughout the study by a telephone-computer to obtain fall incidence; in the case of fall incident(s), a subsequent telephone interview is held to obtain information about the cause and circumstances of falling, fall direction, possible injury and ability to get up from the floor. ***In all groups, three extra urine samples will be obtained at week 4, 8 and 12 of the intervention period.