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Table 1 Sequence of trial measurements for primary and secondary outcomes

From: A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial

 

Baseline

Intervention

Week 12

Week 24

Week 52

Time (months)

−1

1-3

3

6

12

Primary outcome variable

     

FIQRa

x

x

x

x

x

Secondary outcome variables

     

Widespread Pain Index

x

 

x

x

x

Symptom Severity Scale

x

 

x

x

x

Participant Global Assessment

x

 

x

x

x

Pittsburgh Sleep Quality Index

x

 

x

x

x

Patients’ Global fibromyalgia Severity

x

 

x

x

x

SF-36

x

 

x

x

x

Beck II Depression Inventory

x

 

x

x

x

Perceived Stress Scale

x

 

x

x

x

Chronic Pain Self-Efficacy

x

 

x

x

x

Social Support Survey

x

 

x

x

x

Coping Strategies Questionnaire

x

 

x

x

x

MOS Social Support Survey

x

 

x

x

x

OES for exercise

x

 

x

x

x

OES for Tai Chi/AE

 

x

   

PROMISb

x

 

x

x

x

Health Assessment Questionnaire

x

 

x

x

x

NEO Five-Factor Inventoryc

x

 

x

x

x

Five Facet Mindfulness

x

 

x

x

x

Credibility-Expectancyd

x

  

x

x

Pre-clinical disability

x

 

x

x

x

The Hospital Anxiety and Depression Scale

x

 

x

x

x

CHAMPS activities

x

 

x

x

x

Functional Performance Testse

x

 

x

x

x

Body mass index

x

 

x

x

x

Medications

x

 

x

x

x

Adverse events

x

x

   

Adherence

x

x

x

x

x

  1. aRevised Fibromyalgia Impact Questionnaire (FIQR) is the primary outcome at 24 weeks; the other collection times are secondary outcome variables. bParticipant-Reported Outcomes Measurement Information System (PROMIS) questionnaires include PROMIS Pain Impact, PROMIS Physical Function, PROMIS Depression, PROMIS Anxiety, PROMIS Sleep Disturbance, Satisfaction with Social Roles, and PROMIS Health Assessment Questionnaire. cThe NEO Five-Factor Inventory is given out once over the course of the study at the earliest available evaluation period. dThe Credibility-Expectancy Questionnaire is given out before the start of the first intervention session. eFunctional Performance Tests include timed chair stand, one leg stand, 6-minute walk, and muscle strength and power. AE, aerobic exercise; MOS, Medical Outcome Study; OES, Outcome Expectations Scale; SF-36, Medical Outcome Survey Short-Form 36; CHAMPS, Community Health Activities Model Program for Seniors