Skip to main content

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

 
 

Tests

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]

muscles

 

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.
Back to article page

BMC Neurology

ISSN: 1471-2377

Contact us