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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.