A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): protocol for a randomised controlled feasibility study

Abstract

Background Osteoarthritis is a highly prevalent condition in older adults, that causes many sufferers to require a hip or knee replacement in order to improve their quality of life and reduce pain. Individuals waiting for hip or knee replacements are often highly sedentary; thus, it is pertinent to assess whether reducing their sedentariness prior to surgery may aid in improving post-operative outcomes. Methods/design The study will be a randomised controlled feasibility trial design, with 2:1 randomisation into an intervention and usual care group respectively. A target of 45 patients aged 60 years or older waiting for elective hip and knee replacements will be recruited from Russells Hall Hospital, Dudley, UK, approximately 8–10 weeks before surgery. The intervention, informed by Self-Determination Theory (SDT), will be composed of multiple behaviour change techniques, namely, motivational interviewing, feedback on current objectively measured sedentary behaviour and activity, goal-setting, environmental modification, self-monitoring, and social support. Assessments will occur at baseline, 1 week pre-surgery, and 6 weeks post-surgery. The primary outcome will be the feasibility of intervention delivery and of the trial procedures, assessed quantitatively based on rates of recruitment, retention, measures-completion, and intervention fidelity assessment, and with mixed-methods assessment of acceptability, practicality, adaption, satisfaction, and safety. Exploratory outcomes will include physical function, cardiometabolic biomarkers, measurement of SDT constructs, and both objective and subjective measurement of physical activity and sedentariness. The study will last up to 18 weeks per participant. No formal between-group comparisons are planned, but the variance in within-group changes and differences between groups in outcome measures will be explored and reported with 95% confidence intervals. Discussion This is the first study assessing the feasibility of an intervention to reduce sedentary behaviour in older adults with mobility limitations, and the first to assess whether such a reduction could work in a prehabilitative context prior to surgery. The results of this study will help inform the design of a definitive randomised controlled trial. Trial registration This trial is registered on Clinicaltrials.gov . Registration number: NCT03740412 . Date of registration: 13/11/2018. Electronic supplementary material The online version of this article (10.1186/s40814-019-0437-2) contains supplementary material, which is available to authorized users.

A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): results of a randomised-controlled feasibility study

“…We assessed acceptability, practicality, adaptation, satisfaction, and safety, in line with guidance from Bowen et al [25]. Qualitative data were collected from these sources: intervention materials (i.e., sedentary behaviour booklet, in which participants wrote their goals and recorded their adherence, available in the supplementary files of the published protocol [23]), feasibility questionnaires (which contained open questions), and a single semi-structured interview which was conducted with the primary research nurse assigned to the project. The purpose of the interview was to assess satisfaction, practicality, and ideas for adaptation of the recruitment process in INTEREST.…”

“…Changes in Basic Psychological Needs, a construct within Self-Determination Theory, were assessed using the Basic Psychological Needs in General Scale (BPNS) [32]. See the published protocol and Table 1 for full details [23].…”

“…These were delivered in two visits (visit 2 and 3, which could be combined) and took place at the participants' homes. The intervention's development and full details of its content and supporting materials are available in the published protocol [23].…”

“…Treatment receipt was assessed through independent ratings of action plans formulated by participants, according to completeness and adherence to SMART criteria, which was rated by two independent assessors. Treatment enactment was assessed via reporting of adherence to action plans (comprised of six goals and three environmental modifications) in the booklet provided as part of the intervention (available in supplementary files of the published protocol [23]).…”

“…Out of 21 participants in the intervention group that attended the pre-surgery visit, 16 (76.2%) (T2) entered information in the adherence section in the sedentary behaviour booklet given to participants as part of the intervention [23]. Of these, there was an 88% completion rate for goal adherence.…”