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Table 1 Schedule of enrolment, intervention and assessments

From: A self-directed digital exercise program for hip osteoarthritis (“My Hip Exercise”): protocol for a randomised controlled trial

 

Enrolment

Allocation

Secondary

Primary

Timepoint

 

0w

8w, 16w

24w

Enrolment:

 Eligibility screen

X

   

 Informed consent

X

   

 Allocation

 

X

  

Interventions:

 Control education website (control group only)

    

 My Hip Exercise website (intervention group only)

    

 My Exercise Messages App (intervention group only)

    

Assessments:

Descriptive data

 Age (years)

X

   

 Sex

X

   

 Gender

X

   

 Height (self-reported, metres)

X

   

 Weight (self-reported, kilograms)

X

   

 BMI (calculated from self-reported height and weight)

X

   

 Ethnicity

X

   

 Geographical location (postcode)

X

   

 Education level

X

   

 Current employment status

X

   

 Comorbidities (Self-Administered Comorbidity Questionnaire) [40]

X

   

 Symptoms in other joints

X

   

 Duration of symptoms (years)

X

   

 Medication usage

X

   

Primary outcomes

 Severity of hip pain during walking (11-point NRS)

X

  

X

 Physical function subscale of the WOMAC [44]

X

  

X

Secondary outcomes

 Pain subscale of HOOS [45]

X

  

X

 Function, sports and recreational activities subscale of HOOS [45]

X

  

X

 Hip-related quality-of-life subscale of HOOS [45]

X

  

X

 Global rating of overall change in hip condition

   

X

 Health-related quality of life (AQoL-8D) [46]

X

  

X

 Incidental and Planned Exercise Questionnaire (IPEQ-W) [47]

X

  

X

 Global rating of change in physical activity

   

X

 Brief Fear of Movement Scale for OA [48]

X

  

X

 Pain subscale of the Arthritis Self Efficacy Scale [49]

X

  

X

 Self-efficacy for exercise scale [50]

X

  

X

 Use of oral pain medications for hip pain

   

X

Process measures

 Website visits a

  

X

X

 Downloaded exercise programs (intervention group only) b

   

X

 Number of days home strengthening exercise performed (intervention group only) c

  

X

X

 Exercise Adherence Rating Scale [EARS] Section B (intervention group only)

   

X

 Downloaded “My Exercise Messages” app (intervention group only)

   

X

 Frequency of entering exercise into the “My Exercise Messages” app (intervention group only) d

   

X

 Use of the “My Exercise Messages” app (intervention group only) e

  

X

X

 Usefulness of the “My Hip Exercise” website (intervention group only) f

   

X

 Usefulness of the “My Exercise Messages” app (intervention group only) g

   

X

 Exercise equipment use (intervention group only) h

   

X

 Registration to recommended external websites (intervention group only) i

   

X

Other measures

 Co-intervention use

   

X

 Leg strengthening exercises in the past 24 weeks (control group only)

   

X

 Adverse events

   

X

  1. WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, BMI Body Mass Index, OA Osteoarthritis, NRS Numeric rating scale, HOOS Hip dysfunction and Osteoarthritis Outcome Score
  2. aSelf-reported. Participants will be asked “How many times did you visit the website over the past 2 months?” with response options: “never”, “1–5 times”, “6–10 times” and “ > 10 times”
  3. bYes/No response to “Did you download any of the exercise programs from the website as PDF documents?” for programs 1, 2, and 3
  4. cSelf-reported. Participants will be asked “In the past two weeks, on how many days did you perform the strengthening exercises from the “My Hip Exercise” program (0–14)
  5. dSelf-reported. Scored on a 5-point Likert scale for “How often did you enter your number of exercise days into the app as requested” (Never, rarely, sometimes, often, always)
  6. eSelf-reported. Participants will be asked “On how many days in the past 14 days did you use the “My Exercise Messages” app (including reading any notifications, entering data and/or opening the app)” with response options: “never”, “1–5 times”, “6–10 times” and “ > 10 times”
  7. fSelf-reported. Scored on an 11-point NRS for “How useful did you find the “My Hip Exercise” website program? (not including the app)” from 0 = “not at all useful” to 10 = “extremely useful”
  8. gSelf-reported. Scored on an 11-point NRS for “How useful did you find the “My Exercise Messages” app?” from 0 = “not at all useful” to 10 = “extremely useful”
  9. hYes/No response to “Did you use exercise equipment (such as weights or elastic bands) to add resistance to your leg for your strengthening exercises?”
  10. iYes/No response to “Did you register for this course?” for 1) an online course “Taking Control of Your Hip and Knee Osteoarthritis,” and 2) an online course “PainTRAINER”
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BMC Musculoskeletal Disorders

ISSN: 1471-2474

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