Dataset Information

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.

SUBMITTER: Aunger JA

PROVIDER: S-EPMC6451782 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

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

Aunger Justin Avery JA Greaves Colin James CJ Davis Edward T ET Greig Carolyn Anne CA

Pilot and feasibility studies 20190406

<h4>Background</h4>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.<h4>Methods/design</h4>The study will be a randomised controlled feasibility trial des ...[more]

PMID: 30997142

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Project description:BACKGROUND: The study determined the one year incidence of post operative cognitive decline (POCD) and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age) undergoing elective orthopaedic or abdominal surgery. METHODS AND TRIAL DESIGN: The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. RESULTS: In the 52 week prospective cohort study (192 surgical patients and 138 controls), mild (?(2) = 17.9 p<0.0001), moderate (?(2) = 7.8 p = 0.005) and severe (?(2) = 5.1 p = 0.02) POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control). In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher's Exact Test p = 0.018, ?(2) = 5.1 p = 0.02 and ?(2) = 5.9 p = 0.015), and moderate POCD was reduced at 1 and 52 weeks (?(2) = 4.4 p = 0·037 and ?(2) = 5.4 p = 0.02). In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z = -2.1 p = 0.03, MWU Z = -2.7 p = 0.004, MWU Z = -3.0 p = 0.005), in MMSE at one and 52 weeks (MWU Z = -2.9 p = 0.003, MWU Z = -3.3 p = 0.001), and in executive function at 12 and 52 weeks (Trail Making MWU Z = -2.4 p = .0.018, MWU Z = -2.4 p = 0.019). CONCLUSION: POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN39503939.

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Dataset Information

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

Background

Methods/design

Discussion

Trial registration

Publications

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

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