Table 4.
For exploratory aim 1, the primary outcomes include primary outcomes for specific aim 1 and treatment fidelity. For exploratory aim 2, the primary outcomes include primary outcomes for specific aim 1 and specific aim 2.
| Title and description | Time collected | ||||||||||
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Pre | During | Week 8 | Week 12 | |||||||
| Feasibility aim | |||||||||||
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Recruitment | ||||||||||
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Rate of recruitment (participants enrolled) per year | Xa | X | X | X | |||||
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Number of participants screened per month | X | X | X | X | ||||
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Number of participants enrolled per month | X | X | X | X | ||||
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Number of participants lost to follow-up per month | X | X | X | X | ||||
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Rate of retention per year | X | X | X | X | ||||
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Treatment fidelity | ||||||||||
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Adequate knowledge of education program at 8-week follow-up | X | —b | X | — | |||||
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Rating of audio recording by external reviewers for confidence of participant group allocation on 0-5 scale | — | X | — | — | ||||
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Time participants spent in treatment sessions | — | X | — | — | ||||
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Time participants spent doing education homework between sessions | — | — | X | — | ||||
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Adequate blinding of participants to bias of research team
|
— | — | X | — | ||||
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Duration of each exercise phase | — | X | — | — | ||||
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Highest loading level attained at each exercise phase | — | X | — | — | ||||
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Therapeutic alliance
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— | — | X | — | ||||
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Adherence to exercise program |
|
X |
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||||
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Outcome capture rate | ||||||||||
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Percentage of missing data per outcome | X | X | X | X | |||||
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Reasons for missing data | X | X | X | X | ||||
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AEsc | ||||||||||
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Frequency and type of AEs | X | X | X | X | |||||
| Other prespecified outcomes | |||||||||||
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Demographics | ||||||||||
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Date of birth, sex, race/ethnicity, height/weight/BMI, description of ATd symptoms, goals for physical therapy, previous experience with conservative care, comorbidities | X | — | — | — | |||||
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Four square step test | ||||||||||
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Participants will perform a series of steps in a square formation. The duration of time needed to complete the step reflects dynamic balance and mobility | X | — | — | — | |||||
|
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Ultrasound imaging of tendon pathology | ||||||||||
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Ultrasound imaging will be used to quantify tendon thickness, echogenicity, presence of osteophytes/bone spur | X | — | X | — | |||||
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Medication | ||||||||||
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History, current use, and dose of all routine medications and specific questions about opioid use | X | — | X | X | |||||
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Treatment history | ||||||||||
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Treatments previously tried and if they were effective at reducing pain | X | — | — | — | |||||
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Mode of participants’ complete visits | ||||||||||
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Percentage of participants who completed all visits (evaluation sessions 1 and 2 and follow-up visits) through in-person visits compared with those who completed a percentage of visits through telehealth format |
|
— | — | X | |||||
aOutcome collected at timepoint.
bOutcome not collected at timepoint.
cAEs: adverse events.
dAT: Achilles tendinopathy.