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Table 4 Planned participant secondary outcome measures for randomised controlled trial

From: Feasibility of a theoretically grounded, multicomponent, physiotherapy intervention aiming to promote autonomous motivation to adopt and maintain physical activity in patients with lower-limb osteoarthritis: protocol for a single-arm trial

Outcome domain

Instrument

Administered at

Rationale

Physical activity

Short-Form (7 questions) International Physical Activity Questionnaire [48]

Baseline, 3 months, 6 months

Primary aim of physiotherapy intervention. Has demonstrated reliability and validity [48]

Adherence to PA/exercise recommendations

Section B of the Exercise Adherence Rating Scale (6 items) [49]

Baseline, 3 months, 6-month post-baseline

Primary aim of the physiotherapy intervention. Has demonstrated reliability [49] and validity [50]

Pain

11-point Numerical Pain Rating Scale [51]

Baseline, 3 months, 6 months

Suggested to include as a core outcome domain in international guidelines [51]. Shown excellent reliability [52] and suggested as more reliable than a visual analogue scale in patients who are older or less literate patients and more useful for demonstrating change [53]

Function: Self-report

Short-Form Hip Disability and Osteoarthritis Outcome Score (SF-HOOS)/Short-From Knee Injury and Osteoarthritis Outcome Score (SF-KOOS) [51]

Baseline, 3 months, 6 months

Suggested to include as a core outcome domain in international guidelines [51]. Have shown good levels of reliability [54, 55]

Function: Performance based

Five times sit-stand test

Baseline, 3 months, 6-month post-baseline

Direct, observable measure of physical function. Has demonstrated excellent validity and reliability when tested in home setting [56]

Figure-of-8 walking test

Baseline, 3 months, 6 months

Direct, observable measure of physical function. Has demonstrated validity and reliability when tested at home [47]

Bothersomeness

Bothersomeness Index: 5-point Likert scale

Baseline, 3 months, 6 months

Outlined as important outcome domain by public involvement representative

Quality of life

EuroQol 5-domain instrument (EQ-5D) [51]

Baseline, 3 months, 6 months

A domain recommended by international guidelines. Has shown good reliability and validity [57]

Self-efficacy for physical activity/exercise

Self-Efficacy for Exercise Scale 9 items [58]

Baseline, 3 months, 6 months

Outlined as an important influence on behaviour change in preliminary work. Measures several aspects of self-efficacy including perceived barriers to exercise [59]. Valid and reliable [58]

Motivation regulations to participate in physical activity/exercise

Behavioural Regulation in Exercise Questionnaire-3 24 items [60, 61]

Baseline, 3 months, 6 months

Motivation was outlined as important influence on behaviour change in preliminary work. Grounded in SDT. Important stage of intervention process model. Valid [60, 62] and reliability [63]

Psychological needs satisfaction

A modified version of the Psychological Need Satisfaction in Exercise Scale [64, 65]

Baseline, 3 months, 6 months

Grounded in SDT. Important stage of intervention process model. Valid and reliable [64, 65]

Social psychological environment/perceptions of autonomy support

Health Care Climate Questionnaire 15 items [66]

3-month post-baseline

Assesses the participants perceptions of the motivational social climate provided in physiotherapy sessions. Grounded in SDT. Important stage of intervention process model. Identified as an important influence on behaviour change in preliminary work. Reliable [66]