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Table 3 Summary of measures

From: Effects of adding aerobic physical activity to strengthening exercise on hip osteoarthritis symptoms: protocol for the PHOENIX randomised controlled trial

 

Data collection instrument

Time-points

Baseline

3 mths

9 mths

Descriptive data

 Age, sex, body mass index, education level, current employment status

 

  

 Duration of hip OA symptoms, laterality of symptoms

 

  

 Comorbidities

Self-Administered Comorbidity Questionnaire

  

 Radiographic disease severity

Standard supine AP pelvis x-ray

  

 Expectation of treatment outcome

5-point ordinal scale

  

 Therapeutic alliancea

Working Alliance Inventory-Short Revised questionnaire

   

Primary outcomes

 Overall average hip pain in the past week

11-point NRS

 Physical function in past 48 h

WOMAC physical function subscale

Secondary outcomes

 Pain

WOMAC pain subscale

Hip pain during walking, NRS

 Stiffness

WOMAC stiffness subscale

 Perceived change since baseline

Change in pain, 7-point ordinal scale

 

Change in function, 7-point ordinal scale

 

 Health-related quality of life

AQoL-6D questionnaire

 Muscle strength

Hip extensor strength

 

Hip abductor strength

 

Knee extensor

 

 Physical function

Patient specific functional scale

30 s sit to stand

 

Timed stair climb

 

40 m fast walk

 

 Cardiorespiratory fitness

Submaximal cardiorespiratory fitness

 

Other measures

 Adherence

Number of consultations with physiotherapist

 

 

Number of strength sessions at least “very hard”(RPE)

 

 

Number of activity minutes at minimum prescribed heart rate

 

 

 Treatment fidelity

Number of exercise prescriptions according to protocol

 

 

 Adverse events

Number and nature (related, non-related, severity)

 

 Co-interventions

Number and type

 Satisfaction with exercise programs

11-point NRS

 

 

Mechanistic measures

Body composition (fat mass, lean mass)

 

Inflammatory makers (e.g. IL-6, TNF- α, CRP)

 

Quantitative sensory measures (PPT, TS, CPM)

 

Depression, anxiety, stress (DASS-21 subscale)

Neuropathic pain (PainDETECT)

Self-efficacy for walking (SEWS-D, mGES)

Fear of movement (BFMS)

Sleep quality (PSQI)

Fatigue (MDAF)

  1. NRS Numeric rating scale, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, AQoL-6D Assessment of Quality of Life Instrument, RPE Rate of perceived exertion, IL-6 Include interleukin-6 TNF- α = tumor necrosis factor (TNF-α), and C-reactive protein, PPT Pain pressure threshold, TS Temporal summation, CPM Condition pain modulation, DASS Depression, Anxiety, and Stress Scale, SEWS-D Self-efficacy for Walking Scale – Duration, mGES Modified Gait Efficacy Scale, BFMS Brief Fear of Movement Scale for osteoarthritis, PSQI Pittsburgh Sleep Quality Index, MDAF Multi-Dimensional Assessment of Fatigue, RPE Rate of perceived exertion
  2. aalso recorded at 6 weeks