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Table 3 Outcome measures and instrumentation

From: Exercise therapy and cognitive behavioural therapy to improve fatigue, daily activity performance and quality of life in Postpoliomyelitis Syndrome: the protocol of the FACTS-2-PPS trial

  Instrumentation T1 T2 T3 T4
Primary outcome measures      
Fatigue Checklist Individual Strength (CIS; domain: fatigue) [47] X X X X
Daily activity performance Sickness Impact Profile 68
(SIP-68; domains: mobility range, mobility control, social behaviour) [61]
X X X X
HRQoL Medical Outcome Study 36-Item Short-Form Health Survey (SF-36) [52] X X X X
Secondary outcome measures      
ICF: Body functions      
Pain Visual Analogue Scale (VAS) X X X X
Emotional states Profile of Mood States (POMS) [62, 63] X X X X
Sleep disturbances Nottingham Health Profile (NHP; domain: sleep) [64] X X X X
Cardio-respiratory fitness Submaximal exercise test with cycle ergometer X X X X
Neuromuscular capacity Fixed dynamometry and electrical stimulation X X X X
ICF: Activities/Participation      
Physical activity level in daily life Activity Monitor (StepWatch, Cyma, Seattle, WA) on 7 consecutive days X X X X
Perceived participation Impact on Participation and Autonomy Questionnaire (IPA) [65] X X X X
Functional Capacity Timed-Up-and-Go test (TUG) [66] and
2-minute walk test (2-MWT) [67]
X X X X
ICF: Personal Factors      
Illness cognitions Illness Cognitions Questionnaire (ICQ) [51] X X X X
Coping Coping Inventory for Stressful Situations (CISS-21) [68] X X X X
General Self Efficacy General Self Efficacy Scale (ALCOS-16) [69] X X X X
Effect Modifiers      
General effect modifiers      
Demographic variables (age, gender, education, ethnicity, social-economical status)   X    
PPS main complaints Polio Problem List (PPL) [9] X X X X
PPS disease severity Medical Research Council scale (MRC) [26] X    
Co-morbidity Cumulative Illness Rating Scale (CIRS) [70] X X X X
Serum creatine kinase activity Venipuncture X * X X X
ICF: Environmental factors      
Social support Social Support Inventory (SSL-D) [60] X X X X
HRQoL (partner) Medical Outcome Study 36-Item Short-Form Health Survey (SF-36) [52] X X X X
Coping (partner) Coping Inventory for Stressful Situations (CISS-21) [68] X X X X
Caregiver Strain (partner) Caregiver Strain Index (CSI) [71] X X X X
Economic evaluation      
HRQoL EuroQol-5D [41] X X X X
Resource use Cost diaries X X X X
  1. * In the exercise group two extra blood samples will be obtained at 5 and 10 weeks.
  2. T1; pre-treatment, T2; post-treatment, T3; short-term follow-up, T4; long-term follow-up.