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AbstractObjectiveTo evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery.DesignMulticentre, pragmatic, superiority, randomised controlled trial with economic evaluation.Setting17 UK National Health Service cancer centres.Participants392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196).InterventionsUsual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months.Main outcome measuresDisability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective.ResultsBetween 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale −0.68, −1.23 to −0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) −2.02, −3.11 to −0.93; P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average −£387 (€457; $533) (95% confidence interval −£2491 to £1718; 2015 pricing) and was cost effective compared with usual care.ConclusionsThe PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications.Trial registrationISRCTN Registry ISRCTN35358984.

ObjectiveCompare the effects and costs of remotely monitored exercise-based cardiac telerehabilitation (REMOTE-CR) with centre-based programmes (CBexCR) in adults with coronary heart disease (CHD).MethodsParticipants were randomised to receive 12 weeks of telerehabilitation or centre-based rehabilitation. REMOTE-CR provided individualised exercise prescription, real-time exercise monitoring/coaching and theory-based behavioural strategies via a bespoke telerehabilitation platform; CBexCR provided individualised exercise prescription and coaching via established rehabilitation clinics. Outcomes assessed at baseline, 12 and/or 24 weeks included maximal oxygen uptake (V̇O2max, primary) modifiable cardiovascular risk factors, exercise adherence, motivation, health-related quality of life and programme delivery, hospital service utilisation and medication costs. The primary hypothesis was a non-inferior between-group difference in V̇O2max at 12 weeks (inferiority margin=−1.25 mL/kg/min); inferiority margins were not set for secondary outcomes.Results162 participants (mean 61±12.7 years, 86% men) were randomised. V̇O2 max was comparable in both groups at 12 weeks and REMOTE-CR was non-inferior to CBexCR (REMOTE-CR-CBexCR adjusted mean difference (AMD)=0.51 (95% CI −0.97 to 1.98) mL/kg/min, p=0.48). REMOTE-CR participants were less sedentary at 24 weeks (AMD=−61.5 (95% CI −117.8 to −5.3) min/day, p=0.03), while CBexCR participants had smaller waist (AMD=1.71 (95% CI 0.09 to 3.34) cm, p=0.04) and hip circumferences (AMD=1.16 (95% CI 0.06 to 2.27) cm, p=0.04) at 12 weeks. No other between-group differences were detected. Per capita programme delivery (NZD1130/GBP573 vs NZD3466/GBP1758) and medication costs (NZD331/GBP168 vs NZD605/GBP307, p=0.02) were lower for REMOTE-CR. Hospital service utilisation costs were not statistically significantly different (NZD3459/GBP1754 vs NZD5464/GBP2771, p=0.20).ConclusionREMOTE-CR is an effective, cost-efficient alternative delivery model that could—as a complement to existing services—improve overall utilisation rates by increasing reach and satisfying unique participant preferences.

Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain. WalkBack was a two-armed, randomised controlled trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112). Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60–0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149–295) in the intervention group and 112 days (89–140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group). An individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed. National Health and Medical Research Council, Australia.

The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35–65 years with a body-mass index (BMI) of 28 kg/m2 or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2–9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95–5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64–5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon). The FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity. Scottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06).

BackgroundMany patients with major depressive disorder (MDD) do not respond sufficiently to first-line treatments. Due to its biological and psychological mechanisms, exercise may enhance the effectiveness of other MDD treatments. In a pragmatic randomised superiority trial, we evaluated the clinical and cost-effectiveness of exercise therapy adjunct to guideline-concordant care as usual (CAU) for MDD in specialised mental health care.MethodsMDD outpatients (N = 112; Mage = 37; 51% female) were randomized to CAU (96.9% psychotherapy, 59% pharmacotherapy) or CAU + EX (CAU plus 12 weeks of exercise therapy: one supervised and two home-based aerobic sessions/week). Depressive symptoms were assessed using the Inventory of Depressive Symptomatology-Self Report. Remission was evaluated during follow-up by blinded assessors using the Structured Clinical Interview for DSM-5. The economic evaluation followed a societal perspective.ResultsPatients in the CAU + EX condition were significantly more likely than those in CAU to meet the exercise prescription; however, only 22% fully adhered to it. Depressive symptoms decreased from severe to moderate depression in both conditions, with no significant difference between the conditions on symptom reduction (b = −0.22, [−0.72, 0.29]) or remission rate (OR = 0.06, [−0.20, 0.32]). Evidence for cost-effectiveness was found in the per-protocol (≥ six supervised exercise sessions) but not in the intention-to-treat sample.ConclusionsAdjunct exercise therapy does not provide additional clinical benefits or cost-effectiveness in specialized mental health care. Low adherence to the exercise prescription limits its potential. Cost-effectiveness may be achievable with higher adherence, warranting emphasis on strategies to improve adherence in this population.

SummaryThe trial compared three physiotherapy approaches: manual or exercise therapy compared with a single session of physiotherapy education (SSPT) for people with osteoporotic vertebral fracture(s). At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy.IntroductionTo evaluate the clinical and cost-effectiveness of different physiotherapy approaches for people with osteoporotic vertebral fracture(s) (OVF).Methods>Prospective, multicentre, adaptive, three-arm randomised controlled trial. Six hundred fifteen adults with back pain, osteoporosis, and at least 1 OVF participated. Interventions: 7 individual physiotherapy sessions over 12 weeks focused on either manual therapy or home exercise compared with a single session of physiotherapy education (SSPT). The co-primary outcomes were quality of life and back muscle endurance measured by the QUALEFFO-41 and timed loaded standing (TLS) test at 12 months.ResultsAt 12 months, there were no statistically significant differences between groups. Mean QUALEFFO-41: − 1.3 (exercise), − 0.15 (manual), and − 1.2 (SSPT), a mean difference of − 0.2 (95% CI, − 3.2 to 1.6) for exercise and 1.3 (95% CI, − 1.8 to 2.9) for manual therapy. Mean TLS: 9.8 s (exercise), 13.6 s (manual), and 4.2 s (SSPT), a mean increase of 5.8 s (95% CI, − 4.8 to 20.5) for exercise and 9.7 s (95% CI, 0.1 to 24.9) for manual therapy. Exercise provided more quality-adjusted life years than SSPT but was more expensive. At 4 months, significant changes above SSPT occurred in endurance and balance in manual therapy, and in endurance for those ≤ 70 years, in balance, mobility, and walking in exercise.ConclusionsAdherence was problematic. Benefits at 4 months did not persist and at 12 months, we found no significant differences between treatments. There is inadequate evidence a short physiotherapy intervention of either manual therapy or home exercise provides long-term benefits, but arguably short-term benefits are valuable.Trial registrationISRCTN 49117867.

Disease-modifying biological agents and other drug regimens have substantially improved control of disease activity and joint damage in people with rheumatoid arthritis of the hand. However, commensurate changes in function and quality of life are not always noted. Tailored hand exercises might provide additional improvements, but evidence is lacking. We estimated the effectiveness and cost-effectiveness of tailored hand exercises in addition to usual care during 12 months. In this pragmatic, multicentre, parallel-group trial, at 17 National Health Service sites across the UK we randomly assigned 490 adults with rheumatoid arthritis who had pain and dysfunction of the hands and had been on a stable drug regimen for at least 3 months, to either usual care or usual care plus a tailored strengthening and stretching hand exercise programme. Participants were randomly assigned with stratification by centre. Allocation was computer generated and unmasked to participants and therapists delivering treatment after randomisation. Outcome assessors and all investigators were masked to allocation. Physiotherapists or occupational therapists gave the treatments. The primary outcome was the Michigan Hand Outcomes Questionnaire overall hand function score at 12 months. The analysis was by intention to treat. We calculated cost per quality-adjusted life-year. This trial is registered as ISRCTN 89936343. Between Oct 5, 2009, and May 10, 2011, we screened 1606 people, of whom 490 were randomly assigned to usual care (n=244) or tailored exercises (n=246). 438 of 490 participants (89%) provided 12 month follow-up data. Improvements in overall hand function were 3·6 points (95% CI 1·5–5·7) in the usual care group and 7·9 points (6·0–9·9) in the exercise group (mean difference between groups 4·3, 95% CI 1·5–7·1; p=0·0028). Pain, drug regimens, and health-care resource use were stable for 12 months, with no difference between the groups. No serious adverse events associated with the treatment were recorded. The cost of tailored hand exercise was £156 per person; cost per quality-adjusted life-year was £9549 with the EQ-5D (£17 941 with imputation for missing data). We have shown that a tailored hand exercise programme is a worthwhile, low-cost intervention to provide as an adjunct to various drug regimens. Maximisation of the benefits of biological and DMARD regimens in terms of function, disability, and health-related quality of life should be an important treatment aim. UK National Institute of Health Research Health Technology Assessment Programme (NIHR HTA), project number 07/32/05.

Falls among older adults are a growing public health issue, and are associated with injuries and increased societal costs. Therefore, implementation of effective fall prevention interventions is important. Given limited healthcare resources, evaluating the cost-effectiveness of these interventions is essential. Therefore, we aimed to evaluate the cost-effectiveness of the In Balance fall prevention intervention for community-dwelling older adults with an increased risk of falls compared to general physical activity recommendations (control) from a societal perspective. An economic evaluation was conducted alongside a twelve month, single-blind, multicenter randomized controlled trial. Participants were 264 non- and pre-frail community-dwelling adults aged 65 years or older with an increased fall risk. We assessed costs from a societal perspective and effects included the number of falls, fall-related injuries, and Quality-Adjusted Life Years (QALYs) based on the EuroQol Five-level questionnaire (EQ-5D-5L) and the Adult Social Care Outcomes Toolkit (ASCOT). Missing data were handled using Multiple Imputation by Chained Equations (MICE). Incremental costs and effects were estimated using Seemingly Unrelated Regressions and used to estimate Incremental cost-effectiveness ratios (ICERs). On average, In Balance was less expensive and more effective than control, but differences were not statistically significant. ICERs indicated dominance of the intervention for prevented falls (€-14,329 per prevented fall), prevented fall-related injuries (€-14,569 per prevented injury), and QALYs based on both the EQ-5D-5L (€-168,265 per QALY gained) and ASCOT (€-135,797 per QALY gained). The probability of cost-effectiveness of In Balance compared to control was 98% at a willingness to pay (WTP) of €0 per unit of effect gained. Based on this study, we conclude that In Balance may be considered cost-effective compared to control. Future research should explore whether In Balance as part of a comprehensive fall prevention strategy is cost-effective. Research with human participants: NL9248 (registered February 13 2021, URL: https://www.onderzoekmetmensen.nl/nl/trial/26195).

Background Chronic non-specific low back pain (CNLBP) is a prevalent and costly condition that encourages research into self-management strategies. Mobile health (mhealth) applications are promising interventions, but current evidence on their effectiveness is still conflicting. The aim is to investigate the (cost-)effectiveness of a supervised and personalized mhealth intervention, compared with conventional exercise therapy in individuals with CNLBP. Methods A multicentre trial-based economic evaluation was designed to compare a mhealth intervention with conventional exercise. Participants will be recruited from two physical therapy rehabilitation clinics located within the participating centres. Adults aged between 18 and 59 years and with self-reported LBP > 12 weeks will be included. Following the collection of baseline data, participants will be randomly assigned to one of two groups using a permuted block randomization: (1) mhealth; (2) Conventional exercise delivered through a booklet. Outcome assessments will be conducted following randomisation at five distinct time points, resulting in a total follow-up period of 12 months. The primary clinical outcome is disability (Roland-Morris Disability Questionnaire), while secondary outcomes include pain (NRS), utility (Eq. 5D5L), fears and beliefs (FABQ), self-efficacy (PSEQ), and global perceived effect. A sample size of 146 participants was estimated (73 allocated to each group) to detect a 2-point between-groups difference on disability. A cost-effectiveness study will be conducted alongside the trial, comparing the two interventions in terms of costs and clinical outcomes. Discussion While mhealth applications show promise as interventions for people with LBP, there is still a gap regarding the type of delivery and personalisation strategies. This study investigates whether the implementation of stratified and tailored care within a mobile application, based on patient-reported outcome measures and supervised by a physiotherapist, is (cost-)effective. Trial registration: NCT06651099 (registration date 21/10/2024).

Background Exercise is an effective strategy to reduce cancer- and treatment-related side effects and improve quality of life (QoL). Larger exercise effects are observed in cancer survivors with a higher symptom burden and when exercise interventions are supervised. Most studies conducted to date have not screened for symptoms at baseline and tailored the exercise intervention accordingly. Additionally, time and travel distance are common barriers to participation in supervised in-person exercise programs. Live-remote exercise, where exercise sessions are supervised by an exercise professional via a videoconferencing platform, might help overcome these barriers. Here, we describe the design of the LION randomized controlled trial (RCT). This RCT aims to assess the (cost-)effectiveness of side effect-targeted, live-remote exercise on QoL and the participants’ most burdensome side effect—fatigue, emotional distress, low physical functioning, or chemotherapy-induced peripheral neuropathy (CIPN)—in individuals who have completed primary curative cancer treatment. Methods The LION study is a multinational RCT that will enroll 352 individuals who have completed primary curative cancer treatment including chemotherapy, within the previous 12–52 weeks and screen positive for ≥ 1 of the targeted side effects. Participants are randomly allocated (1:1) to the intervention or wait list control group. Participants in the intervention group receive a 12-week supervised exercise program consisting of three live-remote exercise sessions per week. Each participant receives the same base module (2×/week) and one specific module (1×/week) targeting their most burdensome side effect. Wait list control participants receive the same exercise program 12 weeks post-baseline. The primary outcomes are HRQoL (EORTC QLQ-C30 summary score) and a standardized symptom score based on each participant’s most burdensome side effect (physical fatigue: EORTC QLQ-FA12, emotional distress: PHQ-ADS, physical functioning: EORTC QLQ-C30 modified physical functioning scale, CIPN: EORTC QLQ-CIPN20), assessed at baseline, 6, 12 (primary time point), 18 (wait list control group only), 24 and 36 weeks post-baseline. Discussion This RCT will provide evidence regarding the (cost-)effectiveness of side effect-targeted, live-remote exercise in individuals experiencing side effects following primary curative cancer treatment. If proven (cost-)effective, live-remote exercise could be offered to individuals as part of standard follow-up cancer care to extend the reach of exercise support. Trial registration NCT06270628. Registered on February 13, 2024.