CycLing and EducATion (CLEAT): protocol for a single centre randomised controlled trial of a cycling and education intervention versus standard physiotherapy care for the treatment of hip osteoarthritis

Table 1 SPIRIT^* diagram of enrolment, treatment, and assessments for the CLEAT study

Timepoint	Visit 1: Verbal consent and pre-baseline	Visits 1 and 2 may be combined Visit 2: Baseline (≤ 2 weeks prior to start of treatment)	Visit 3: Treatment	Visit 4: Post treatment (≤ 2 weeks after end of 8 weeks treatment period)	Visit 5: Long term follow-up (3 months post Visit 4 (± 4 weeks))
Enrolment:
Eligibility screening (including medical history)		X
Informed Consent	X verbal	X written
Randomisation		X
Interventions:
CHAIN			X
Standard care physiotherapy			X
Assessments:
Primary outcome
^†HOOS (function, daily living)		X		X
Secondary outcomes
HOOS (function, daily living)		X			X
HOOS (other subscales)		X		X	X
^‡PAM		X		X	X
30-sec sit-stand test		X		X
Stair climb test		X		X
40 m walk test		X		X
^§BMI, % body fat, ^¶BP,		X		X
resting ^#HR
Analgesia Use (**RUQ)		X		X	X
Other measures
Psychological questionnaire and patient feedback (CHAIN arm only)				X
Interaction with CHAIN video content			X
Range of motion of hip		X		X
^††PSFS		X		X	X
Exercise Diary			X
Adverse Events		X	X	X
Descriptive measures
Age, gender, employment status, ethnicity, education		X
Health economic data
EQ-5D-5 L		X		X	X
RUQ		X		X	X

*Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT); ^†Hip Disability and Osteoarthritis Outcome Score (HOOS); ^‡Patient Activation Measure (PAM); ^§Body Mass Index (BMI); ^¶Blood Pressure (BP); ^#Heart Rate (HR); **Resource Use Questionnaire (RUQ); ^††Patient-Specific Functional Scale (PSFS)

ISSN: 1471-2474