Getting Recovery Right After Neck Dissection (GRRAND-F): Mixed-methods feasibility study to design a pragmatic randomised controlled trial.

Objective: To determine the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention following neck dissection (ND) after head and neck cancer (HNC). Design: Two-arm, open, pragmatic, parallel, multicentre, randomised controlled feasibility trial. Setting: Two UK NHS hospitals. Participants: People who had HNC in whom a ND was part of their care. We excluded those with a life expectancy of six months or less, pre-existing, long-term neurological disease affecting the shoulder and cognitive impairment. Intervention: Usual care (standard care supplemented with a booklet on postoperative self-management) was received by all participants. The GRRAND intervention programme consisted of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion and progressive resistance exercises, advice and education. Between sessions, participants were advised to complete a home exercise programme. Randomisation: 1:1 randomisation. Allocation was based on minimisation, stratified by hospital site and spinal accessory nerve sacrifice. It was not possible to mask treatment received. Main outcome measures: Primary: Participant recruitment, retention and fidelity to the study protocol and interventions from study participants and staff at six months post-randomisation (and 12 months for those reaching that time-point). Secondary: clinical measures of pain, function, physical performance, health-related quality of life, health utilisation and adverse events. Results: 36 participants were recruited and enrolled. The study achieved five of its six feasibility targets. These included consent - 70% of eligible participants were consented; intervention fidelity - 78% participants discharged completed the intervention sessions; contamination - none - no participants in the control arm received the GRRAND-F intervention and retention - 8% of participants were lost to follow-up. The only feasibility target that was not achieved was the recruitment target where only 36 of the planned 60 participants were recruited over 18 months. This was principally due to the COVID-19 pandemic which caused all research activity to be paused or reduced, with a subsequent reduction in. Conclusions: Based on the findings a full-trial can now be designed to better understand whether this proposed intervention is effective. Clinical Trial Registration: https://www.isrctn.com/ISRCTN1197999, identifier ISRCTN11979997.

Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis: study protocol for a feasibility randomised controlled trial.

BACKGROUND: Exercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be generalised to people aged 80 years or older. Rapid loss of muscle occurs after 70 years of age, and older people are more likely to also have other health conditions that contribute to difficulties with daily activities and impact on their response to exercise. To improve care for people aged 80 or older with osteoarthritis, it is thought that a tailored exercise intervention targeting both osteoarthritis and any other health conditions they have, may be needed. The aim of this study will be to test if it is possible to conduct a randomised controlled trial (RCT) for people over 80 years of age with hip/knee osteoarthritis of a tailored exercise intervention. METHODS: A multicentre, parallel, 2-group, feasibility RCT with embedded qualitative study, conducted in ≥ 3 UK NHS physiotherapy outpatient services. Participants (n ≥ 50) with clinical knee and/or hip osteoarthritis and ≥ 1 comorbidity will be recruited by screening referrals to participating NHS physiotherapy outpatient services, via screening of general practice records and via identification of eligible individuals from a cohort study run by our research group. Participants will be randomised (computer-generated: 1:1) to receive either: a 12-week education and tailored exercise intervention (TEMPO); or usual care and written information. The primary feasibility objectives are to estimate: (1) ability to screen and recruit eligible participants; (2) retention of participants, measured by the proportion of participants who provide outcome data at 14-week follow-up. Secondary quantitative objectives are to estimate: (1) participant engagement assessed by physiotherapy session attendance and home exercise adherence; (2) sample size calculation for a definitive RCT. One-to-one semi-structured interviews will explore the experiences of trial participants and physiotherapists delivering the TEMPO programme. DISCUSSION: Progression criteria will be used to determine whether a definitive trial to evaluate the clinical and cost-effectiveness of the TEMPO programme is considered feasible with or without modifications to the intervention or trial design. TRIAL REGISTRATION: ISRCTN75983430. Registered 3/12/2021. https://www.isrctn.com/ISRCTN75983430.

Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial.

OBJECTIVE: To test the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after total hip replacement (THR) or total knee replacement (TKR). DESIGN: Multicentre, pragmatic, two-arm, open, randomised controlled, superiority trial. SETTING: National Health Service providers in nine English hospitals. PARTICIPANTS: 224 individuals aged ≥18 years, undergoing a primary THR or TKR deemed 'moderately inactive' or 'inactive'. INTERVENTION: Participants received either six, 30 min, weekly, group-based exercise sessions (usual care) or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental). RANDOMISATION AND BLINDING: Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). Allocation was based on minimisation, stratifying on comorbidities, operation type and hospital. There was no blinding. MAIN OUTCOME MEASURES: Primary: University of California Los Angeles (UCLA) Activity Score at 12 months. Secondary: 6 and 12-month assessed function, pain, self-efficacy, kinesiophobia, psychological distress and quality of life. RESULTS: Of the 1254 participants assessed for eligibility, 224 were included (139 experimental: 85 usual care). Mean age was 68.4 years (SD: 8.7), 63% were women, 52% underwent TKR. There was no between-group difference in UCLA score (mean difference: -0.03 (95% CI -0.52 to 0.45, p=0.89)). There were no differences observed in any of the secondary outcomes at 6 or 12 months. There were no important adverse events in either group. The COVID-19 pandemic contributed to the reduced intended sample size (target 260) and reduced intervention compliance. CONCLUSIONS: There is no evidence to suggest attending usual care physiotherapy sessions plus a group-based behaviour change intervention differs to attending usual care physiotherapy alone. As the trial could not reach its intended sample size, nor a proportion of participants receive their intended rehabilitation, this should be interpreted with caution. TRIAL REGISTRATION NUMBER: ISRCTN29770908.

The Clinical Effectiveness of a Physiotherapy Delivered Physical and Psychological Group Intervention for Older Adults With Neurogenic Claudication: The BOOST Randomized Controlled Trial.

BACKGROUND: Neurogenic claudication (NC) is a debilitating spinal condition affecting older adults' mobility and quality of life. METHODS: A randomized controlled trial of 438 participants evaluated the effectiveness of a physical and psychological group intervention (BOOST program) compared to physiotherapy assessment and tailored advice (best practice advice [BPA]) for older adults with NC. Participants were identified from spinal clinics (community and secondary care) and general practice records and randomized 2:1 to the BOOST program or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data were also collected at 6 months. Other outcomes included ODI walking item, 6-minute walk test (6MWT), and falls. The primary analysis was intention-to-treat. RESULTS: The average age of participants was 74.9 years (standard deviation [SD] 6.0) and 57% (246/435) were female. There was no significant difference in ODI scores between treatment groups at 12 months (adjusted mean difference [MD]: -1.4 [95% confidence intervals (CI) -4.03, 1.17]), but, at 6 months, ODI scores favored the BOOST program (adjusted MD: -3.7 [95% CI -6.27, -1.06]). At 12 months, the BOOST program resulted in greater improvements in walking capacity (6MWT MD: 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD: -0.2 [95% CI -0.45, -0.01]) and reduced falls risk (odds ratio: 0.6 [95% CI 0.40, 0.98]) compared to BPA. No serious adverse events were related to either treatment. CONCLUSIONS: The BOOST program substantially improved mobility for older adults with NC. Future iterations of the program will consider ways to improve long-term pain-related disability. Clinical Trials Registration Number: ISRCTN12698674.

The Prevalence of Back and Leg Pain and the Cross-sectional Association With Adverse Health Outcomes in Community Dwelling Older Adults in England.

STUDY DESIGN: Cross-sectional analysis of the Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study. OBJECTIVE: The aim of this study was to assess the prevalence of back pain (BP) and leg pain and determine their relationship with adverse health states among older adults in England. SUMMARY OF BACKGROUND DATA: Epidemiological data describing the prevalence of BP and leg pain in older adults in England is lacking. METHODS: A total of 5304 community-dwelling adults (aged 65-100 years) enrolled in the OPAL cohort study who provided data on BP and leg pain were included. Participants were classified into four groups based on reports of back and leg pain: no BP, BP only, BP and leg pain which was likely to be neurogenic claudication (NC), and BP and leg pain which was not NC. Adverse health states were frailty, falls, mobility decline, low walking confidence, poor sleep quality, and urinary incontinence. We collected demographic and socioeconomic information, health-related quality of life, and existing health conditions, and estimated the association between BP presentations and adverse health states using regression analysis. RESULTS: Thirty-four percent of participants (1786/5304) reported BP only, 11.2% (n = 594/5304) reported BP and NC and 8.3% (n = 441/5304) reported BP and non-NC leg pain. Participants with BP had worse quality of life compared to those without BP. All BP presentations were significantly associated with adverse health states. Those with NC were most affected. In particular, there was greater relative risk (RR) of low walking confidence (RR 3.11, 95% confidence interval [CI] 2.56-3.78), frailty (RR 1.88, 95% CI 1.67-2.11), and mobility decline (RR 1.74, 95% CI 1.54-1.97) compared to no BP. CONCLUSION: Back and leg pain is a common problem for older adults and associated with reduced quality of life and adverse health states. Findings suggest a need to develop more effective treatment for older adults with BP especially for those with neurogenic claudication. LEVEL OF EVIDENCE: 2.

Synergistic effects of hip/knee osteoarthritis and comorbidities on mobility and self-care limitations among older adults: Cross-sectional analysis of the Oxford pain, Activity and Lifestyle study.

OBJECTIVE: To estimate synergistic effects of hip/knee osteoarthritis (OA) and comorbidities on mobility or self-care limitations among older adults. METHODS: We used baseline, cross-sectional data from the Oxford Pain, Activity and Lifestyle (OPAL) study. Participants were community-dwelling adults aged 65 years or older who completed a postal questionnaire. Participants reported demographic information, hip/knee OA, comorbidities and mobility and self-care limitations. We used modified Poisson regression models to estimate the independent and combined relative risks (RR) of mobility or self-care limitations, the relative excess risk due to interaction (RERI) between hip/knee OA and comorbidities, attributable proportion of the risk due to the interaction and the ratio of the combined effect and the sum of the individual effects, known as the synergy index. RESULTS: Of the 4,972 participants included, 1,532 (30.8%) had hip/knee OA, and of them 42.9% reported mobility limitations and 8.4% reported self-care limitations. Synergistic effects impacting self-care limitations were observed between hip/knee OA and anxiety (RR: 3.09, 95% Confidence Interval (CI): 2.00 to 4.78; RERI: 0.93, 95% CI: 0.01 to 1.90), and between hip/knee OA and depressive symptoms (RR: 2.71, 95% CI: 1.75 to 4.20; RERI: 0.58, 95% CI: 0.03 to 1.48). The portion of the total RR attributable to this synergism was 30% and 22% respectively. CONCLUSIONS: This study demonstrates that synergism between hip/knee OA and anxiety or depressive symptoms contribute to self-care limitations. These findings highlight the importance of assessing and addressing anxiety or depressive symptoms when managing older adults with hip/knee OA to minimize self-care limitations.

Cohort profile: Oxford Pain, Activity and Lifestyle (OPAL) Study, a prospective cohort study of older adults in England.

PURPOSE: The 'Oxford Pain, Activity and Lifestyle' (OPAL) Cohort is a longitudinal, prospective cohort study of adults, aged 65 years and older, living in the community which is investigating the determinants of health in later life. Our focus was on musculoskeletal pain and mobility, but the cohort is designed with flexibility to include new elements over time. This paper describes the study design, data collection and baseline characteristics of participants. We also compared the OPAL baseline characteristics with nationally representative data sources. PARTICIPANTS: We randomly selected eligible participants from two stratified age bands (65-74 and 75 and over years). In total, 5409 individuals (42.1% of eligible participants) from 35 general practices in England agreed to participate between 2016 and 2018. The majority of participants (n=5367) also consented for research team to access their UK National Health Service (NHS) Digital and primary healthcare records. FINDINGS TO DATE: Mean participant age was 74.9 years (range 65-100); 51.5% (n=2784/5409) were women. 94.9% of participants were white, and 28.8% lived alone. Over 83.0% reported pain in at least one body area in the previous 6 weeks. Musculoskeletal symptoms were more prevalent in women (86.4%). One-third of participants reported having one or more falls in the last year. Most participants were confident in their ability to walk outside. The characteristics of OPAL Cohort participants were broadly similar to the general population of the same age. FUTURE PLANS: Postal follow-up of the cohort is being undertaken at annual intervals, with data collection ongoing. Linkage to NHS hospital admission data is planned. This English prospective cohort offers a large and rich resource for research on the longitudinal associations between demographic, clinical, and social factors and health trajectories and outcomes in community-dwelling older people.

Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication.

BACKGROUND: Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe the statistical analysis plan for the Better Outcomes for Older people with Spinal trouble (BOOST) randomised controlled trial. METHODS/DESIGN: BOOST is a pragmatic, multicentre, parallel, two-arm, randomised controlled trial. Participants are community-dwelling adults, 65 years or older, with neurogenic claudication, registered prospectively, and randomised 2:1 (intervention to control) to the combined physical and psychological BOOST group physiotherapy programme or best practice advice. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the Short Physical Performance Battery, Swiss Spinal Stenosis Scale, 6 Minute Walk Test, Fear Avoidance Beliefs Questionnaire, and Tilburg Frailty Indicator. Outcomes are measured at 6 and 12 months by researchers blinded to treatment allocation. The primary statistical analysis is by intention to treat. Further study design details are published in the BOOST protocol. DISCUSSION: The planned statistical analyses for the BOOST trial aim to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report. TRIAL REGISTRATION: This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674 . Registered on 10 November 2015.

Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol.

INTRODUCTION: Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention. METHODS AND ANALYSIS: This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by 'intention to treat'. There is a parallel health economic evaluation and qualitative study. ETHICS AND DISSEMINATION: Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website. TRIAL REGISTRATION NUMBER: ISRCTN12698674; Pre-results.