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Table 1 Secondary outcome measures

From: Exercise and fall prevention self-management to reduce mobility-related disability and falls after fall-related lower limb fracture in older people: protocol for the RESTORE (Recovery Exercises and STepping On afteR fracturE) randomised controlled trial

Domain

Assessment

Description

Balance and mobility

Coordinated stability test [53]

Measures ability to adjust body position in a controlled manner when near the limit of the base of support.

Maximal balance range test [53]

Measures the maximum distance participants can lean backward and forward.

Step Test [54]

Dynamic single limb stance is assessed by counting the number of times the participant is able to step one foot on, then off, a 7.5 cm block as quickly as possible in 15 seconds.

Short Physical Performance Battery (SPPB), individual components

The SPPB components are the ability to stand (for 10 sec) with the feet together in the side-by-side, semi-tandem, and tandem positions; time taken to walk four metres; and time to rise from a chair and return to the seated position five times.

Choice stepping reaction time [55]

Time to complete a standardised stepping routine onto four white squares on a portable mat, while standing.

Falls and fall risk

Fallers

Proportion of fallers (people having one or more falls) over the 12-month follow-up period.

Injurious falls and fractures

Number of falls requiring medical attention and fractures over the 12-month follow-up period.

 

Physiological Profile Assessment (PPA) summary score and individual components [53, 56]

Includes five measures of physiological functioning (knee extension strength, postural sway, reaction time, lower limb proprioception and visual contrast sensitivity).

Physical activity

Incidental and Planned Exercise Questionnaire [57]

Level of physical activity relating to both basic and more demanding activities is assessed with a 10-item questionnaire.

Walking aid use

Use of walking aid

The use and type of walking aid is recorded both indoors and outdoors.

Frailty

6-point scale based on the Fried criteria [58]

Frailty is measured using five criteria: unexplained weight loss, grip strength, exhaustion, walking speed, activity level.

Pain

6-point numeric rating scale

The participant selects a whole number that best reflects the intensity of their pain.

Nutritional status

Mini Nutritional Assessment [34]

Screens for, and assesses, malnutrition in older people.

Body mass index

Bodyweight in kilograms divided by height in metres squared.

Fall-related self-efficacy

Questions about self-rated fear of falling and balance

Participants are asked to rate their perceived balance and their fear of falling on 5-point ordinal scales

Short version of the Falls Efficacy Scale-International [59]

Level of concern about falling during a range of activities is rated on a 4-point scale.

Mood

Five-item version of the Geriatric Depression Scale [60]

Screens mood in older people. The five-item Geriatric Depression Scale is comparable with the 15-item version in terms of psychometric properties.

Positive and negative affect

Positive and Negative Affect Scale [61]

Two 10-item scales that measure positive and negative affect.

Health-related quality of life

European Quality of Life-5 dimensions (EQ-5D-5 L) [36]

A standardised measure of health status that provides utility weights to allow calculation of quality adjusted life years (QALYs) for use in the economic evaluation [62].

Short Form 12-item Survey (SF-12) Version 2 [63]

A 12-item questionnaire that measures functional health and well-being.

Assistance from others

Three questions about assistance received

Establishes the presence of, and reason for, assistance from agencies, family or friends.

Hospital re-admission

Number of hospital readmissions and days in hospital during the follow-up period

Ascertained via the same calendars used for falls follow-up over the first 12 months of the study, follow-up phone calls for missing calendars and contact with carers if contact is lost with the participant. At 2 and 4 years after randomisation, data linkage will be undertaken via the New South Wales Centre for Health Record Linkage (NSW CHeReL) to seek information regarding mortality and hospital admissions.

Health-system and community-service contact

Number of contacts with health and community services

Collected on a monthly basis along with the falls calendars. Inpatient hospital and emergency department contact will be assessed using data linkage via the NSW CHeReL. Data will also be used in economic analyses.

The stage of motivational readiness for change

Physical Activity Stages of Change Questionnaire [48]

The 4-item questionnaire measures the stage of readiness to change and self-efficacy to exercise.