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Table 2 Outcome measures and instrumentation

From: Effects of aerobic exercise therapy and cognitive behavioural therapy on functioning and quality of life in amyotrophic lateral sclerosis: protocol of the FACTS-2-ALS trial

Primary outcome measures Instrumentation T0 T1 T2 T3
Quality of life ALS Assessment Questionnaire (ALSAQ-40) [40] X X X X
  Short Form 36 (SF-36) [41] X X X X
ICF: Activities / participation
Self-reported physical activity LASA Physical Activity Questionnaire (LAPAQ) [42] X X X X
Limitations in participation and autonomy The Impact on Participation and Autonomy questionnaire (IPA) [48] X X X X
Self-perceived functional status Sickness Impact Profile 68 (SIP 68; domains: mobility control, mobility range, social behaviour) [44] X X X X
Secondary outcome measures
ICF: Body functions
ALS disease severity ALS Functional Rating Scale Revised (ALSFRS-R) [45] X X X X
Survival Survival in months post diagnosis X X X X
Cardio-respiratory fitness Submaximal exercise test with cycle ergometer [49] X X X X
Functional capacity Stairs test [50] X X X X
  Timed Up and Go (TUG) test [51] X X X X
Muscle strength MicroFET handheld dynamometer X X X X
  Jamar handheld dynamometer X X X X
Lung function Spirometry: forced vital capacity (FVC) [52] X X X X
  Sniff nasal inspiratory pressure (SNIP) [53] X X X X
Fatigue Checklist Individual Strength (CIS; domain: fatigue) [54] X X X X
Sleep disturbances Nottingham Health Profile (NHP; sleep dimension) [55] X X X X
Pain Visual analogue scale, pain (VAS-pain) X X X X
Co-morbidity Cumulative Illness Rating Scale (CIRS) [56] X    
  Blood pressure X X X X
  Height / Weight X X X X
  Skinfold X X X X
ICF: Personal Factors     
Illness cognitions Ziekte Cognitie Lijst (ZCL) [57] X X X X
Coping Coping Inventory for Stressful Situations (CISS-21) [58] X X X X
General self-efficacy General Self-Efficacy Scale (ALCOS-16) [59] X    
Personality Eysenck Personality Questionnaire (EPQ-RSS) [60] X    
Mood Hospital Anxiety and Depression Scale (HADS) [32] X X X X
  Profile of Mood States (POMS) [61] X X X X
Impact of events Schokverwerkingslijst (SVL) [62] X X X X
ICF: Environmental factors     
Social support Social Support List - Discrepancies (SSL-D-12) [63] X X X X
Quality of life (partner) Short Form 36 (SF-36) [41] X X X X
Coping (partner) Coping Inventory for Stressful Situations (CISS-21) [58] X X X X
Mood (partner) Hospital Anxiety and Depression Scale (HADS) [32] X X X X
  Profile of Mood States (POMS) [61] X X X X
Caregiver strain (partner) Caregiver Strain Index (CSI) [46] X X X X
Other factors T0 T1 T2 T3
Demographic variables (age, gender, ethnicity, marital status, children, education, work, religion, participation in other study) of patient and partner X    
  1. T1; pre-treatment, T2; post-treatment, T3; short-term follow-up, T4; long-term follow-up.