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Table 1 Schedule of enrolment, interventions, and assessments for the TEMPO study

From: Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis: study protocol for a feasibility randomised controlled trial

 

Pre-randomisation

Baseline Assessment

Intervention period (0–14 weeks)

14-week Assessment

16–18 weeks after randomisation

Enrolment

 Potential participant identification and screening

X

    

 Provision of PIS

X

    

 Eligibility assessment

X

    

 Informed consent

X

    

Assessment

 Demographics

 

X

 

X

 

 Nottingham Extended Activities of Daily Life Scale (NEADL)

 

X

 

X

 

 EuroQol EQ-5D-5L

 

X

 

X

 

 Average, worst and walking hip/knee pain (0–10 NRS)

 

X

 

X

 

 Nordic pain questionnaire

 

X

 

X

 

 Geriatric Depression Scale (GDS-15)

 

X

 

X

 

 Geriatric Anxiety Scale (GAS10)

 

X

 

X

 

 ProFANE self-report of falls and fall related injuries

 

X

 

X

 

 Walking confidence: single item from Modified Gait Self-Efficacy Scale

 

X

 

X

 

 Short Physical Performance Battery (SPPB)

 

X

 

X

 

 Current medications

 

X

   

 Attendance-treatment log (TEMPO intervention)

  

X

  

 Adherence-home exercise diary (TEMPO intervention)

  

X

  

 Adverse events recorded

  

X

X

 

 Additional treatments received

   

X

 

 Postal/phone collection of core outcomes (if required)

    

X

 Qualitative interviews with sample of participants

    

X

Interventions

 Provision of hip/knee OA booklet (usual care)

 

X

   

 Referral to TEMPO physiotherapist

 

X

   

 TEMPO programme: 4–8 individual sessions with physiotherapist

  

X