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Multimodal Prehabilitation to Enhance Functional Capacity Following Radical Cystectomy: A Randomized Controlled Trial.
Minnella, EM, Awasthi, R, Bousquet-Dion, G, Ferreira, V, Austin, B, Audi, C, Tanguay, S, Aprikian, A, Carli, F, Kassouf, W
European urology focus. 2021;(1):132-138
Abstract
BACKGROUND In patients with bladder cancer, poor functional status has remarkable deleterious effects on postoperative outcome and prognosis. Conditioning intervention initiated before surgery has the potential to reduce functional decline attributable to surgery. Nonetheless, evidence is lacking in patients undergoing radical cystectomy. OBJECTIVE To determine whether a preoperative multimodal intervention (prehabilitation) is feasible and effective in radical cystectomy. DESIGN, SETTING, AND PARTICIPANTS This study, conducted at an academic tertiary health care institution, enrolled adult patients scheduled for radical cystectomy. From August 2013 to October 2017, 70 patients were randomized: 35 to multimodal prehabilitation (prehab group) and 35 to standard care (control group). INTERVENTION Multimodal prehabilitation was a preoperative conditioning intervention including aerobic and resistance exercise, diet therapy, and relaxation techniques. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary outcome was perioperative change in functional capacity, measured with the distance covered during a 6-min walk test (6MWD), assessed at baseline, before surgery, and at 4 and 8 wk after surgery. Data were compared using robust mixed linear models for repeated measures. RESULTS AND LIMITATIONS Preoperative change in 6MWD compared with baseline was not significantly different between groups (prehab group 40.8 [114.0] m vs control group 9.7 (108.4) m, p=0.250). However, at 4 wk after surgery, a significant difference in functional capacity was detected (6MWD, prehab group -15.4 [142.5] m vs control group -97.9 [123.8] m, p=0.014). No intervention-related adverse effects were reported. CONCLUSIONS Data suggested that multimodal prehabilitation resulted in faster functional recovery after radical cystectomy. PATIENT SUMMARY After major cancer surgery, people usually feel week and tired, and have less energy to perform activities of daily living. In this study, we showed that using the time before surgery to promote exercise and good nutrition could fasten recovery after the surgical removal of the bladder.
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Effects of a lifestyle intervention on psychosocial well-being of severe mentally ill residential patients: ELIPS, a cluster randomized controlled pragmatic trial.
Stiekema, APM, Looijmans, A, van der Meer, L, Bruggeman, R, Schoevers, RA, Corpeleijn, E, Jörg, F
Schizophrenia research. 2018;:407-413
Abstract
Large studies investigating the psychosocial effects of lifestyle interventions in patients with a severe mental illness (SMI) are scarce, especially in residential patients. This large, randomized controlled, multicentre pragmatic trial assessed the psychosocial effects of a combined diet-and-exercise lifestyle intervention targeting the obesogenic environment of SMI residential patients. Twenty-nine sheltered and clinical care teams were randomized into intervention (n=15) or control (n=14) arm. Team tailored diet-and-exercise lifestyle plans were set up to change the obesogenic environment into a healthier setting, and team members were trained in supporting patients to make healthier choices. The control group received care-as-usual. The Calgary Depression Scale for Schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Health of the Nation Outcome Scales (HoNOS) and the Manchester Short Assessment of Quality of Life (MANSA) were assessed at baseline and after three and twelve months. Data were available for 384 intervention and 386 control patients (48.6±12.5years old, 62.7% males, 73.7% psychotic disorder). Linear mixed model analysis showed no psychosocial improvements in the intervention group compared to care-as-usual; the intervention group showed a slightly reduced quality of life (overall) and a small increase in depressive symptoms (clinical care facilities) and psychotic symptoms (sheltered facilities). This may be due to difficulties with implementation, the intervention not being specifically designed for improvements in mental well-being, or the small change approach, which may take longer to reach an effect. Further research might elucidate what type of lifestyle intervention under what circumstances positively affects psychosocial outcomes in this population.
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Exercise response in Parkinson's disease: insights from a cross-sectional comparison with sedentary controls and a per-protocol analysis of a randomised controlled trial.
Mavrommati, F, Collett, J, Franssen, M, Meaney, A, Sexton, C, Dennis-West, A, Betts, JF, Izadi, H, Bogdanovic, M, Tims, M, et al
BMJ open. 2017;(12):e017194
Abstract
OBJECTIVES To investigate the acute and adaptation cardiovascular and metabolic training responses in people with Parkinson's disease (pwP). DESIGN (1) A cross-sectional study of exercise response of pwP compared with sedentary controls and (2) an interventional study of exercise training in pwP. SETTING Community leisure facilities. PARTICIPANTS pwP (n=83) and sedentary controls (n=55). INTERVENTIONS Study 1 included participants from a two-arm-parallel single-blind phase II randomised controlled trial (RCT), that undertook a baseline maximal incremental exercise test and study 2 included those randomised to the exercise group in the RCT, who completed a 6-month weekly exercise programme (n=37). The intervention study 2 was a prescribed exercise program consisting of sessions lasting 60 min, two times a week over a 6-month period. The control group followed the same protocol which derived the same cardiorespiratory parameters, except that they were instructed to aim for a cadence of ~60 revolutions per minute and the unloaded phase lasted 3 min with an initial step of 25 W. PRIMARY AND SECONDARY OUTCOME MEASURES Stepwise incremental exercise test to volitional exhaustion was the primary outcome measure. RESULTS Study 1 showed higher maximum values for heart rate (HR), VO2 L/min, VCO2 L/min and ventilation L/min for the control group; respiratory exchange ratio (RER), perceived exertion and O2 pulse (VO2 L/min/HR) did not differ between groups. In study 2, for pwP who adhered to training (n=37), RER increased significantly and although there was no significant change in aerobic capacity or HR response, reduced blood pressure was found. CONCLUSIONS An abnormal cardiovascular response to exercise was observed in pwP compared to controls. After the exercise programme, metabolic deficiencies remained for pwP. These observations add to the pathogenic understanding of PD, acknowledge an underling metabolic contribution and support that certain cardiovascular symptoms may improve as a result of this type of exercise.
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Research Exploring Physical Activity in Care Homes (REACH): study protocol for a randomised controlled trial.
Forster, A, Airlie, J, Birch, K, Cicero, R, Cundill, B, Ellwood, A, Godfrey, M, Graham, L, Green, J, Hulme, C, et al
Trials. 2017;(1):182
Abstract
BACKGROUND As life expectancy increases and the number of older people, particularly those aged 85 years and over, expands there is an increase in demand for long-term care. A large proportion of people in a care home setting spend most of their time sedentary, and this is one of the leading preventable causes of death. Encouraging residents to engage in more physical activity could deliver benefits in terms of physical and psychological health, and quality of life. This study is the final stage of a programme of research to develop and preliminarily test an evidence-based intervention designed to enhance opportunities for movement amongst care home residents, thereby increasing levels of physical activity. METHODS/DESIGN This is a cluster randomised feasibility trial, aiming to recruit at least 8-12 residents at each of 12 residential care homes across Yorkshire, UK. Care homes will be randomly allocated on a 1:1 basis to receive either the intervention alongside usual care, or to continue to provide usual care alone. Assessment will be undertaken with participating residents at baseline (prior to care home randomisation) and at 3, 6, and 9 months post-randomisation. Data relating to changes in physical activity, physical function, level of cognitive impairment, mood, perceived health and wellbeing, and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care, and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of National Health Service (NHS) usage will be collected to inform the economic analysis. An embedded process evaluation will obtain information to test out the theory of change underpinning the intervention and its acceptability to staff and residents. DISCUSSION This feasibility trial with embedded process evaluation and collection of health economic data will allow us to undertake detailed feasibility work to inform a future large-scale trial. It will provide valuable information to inform research procedures in this important but challenging area. TRIAL REGISTRATION ISRCTN registry, ISRCTN16076575 . Registered on 25 June 2015.
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A Lifestyle Physical Activity Intervention for Patients with Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial.
Coultas, DB, Jackson, BE, Russo, R, Peoples, J, Sloan, J, Singh, KP, Ashmore, J, Blair, SN, Uhm, M, Bae, S
Annals of the American Thoracic Society. 2016;(5):617-26
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Abstract
RATIONALE Physical inactivity is associated with poor outcomes among patients with chronic obstructive pulmonary disease (COPD). OBJECTIVES To determine effectiveness of a behavioral intervention intended to increase daily physical activity with the goal of improving health-related quality of life and functional performance. METHODS We conducted a randomized trial among patients with COPD cared for in primary care and pulmonary clinics. The patients were at least 45 years of age and eligible for pulmonary rehabilitation. All patients received self-management education during a 6-week run-in period. Subsequently, patients were randomized to usual care or the intervention delivered over 20 weeks. MEASUREMENTS AND MAIN RESULTS Co-primary outcomes were change from baseline in Chronic Respiratory Questionnaire dyspnea domain score and 6-minute-walk distance measured at 6, 12, and 18 months after randomization. A total of 325 patients were enrolled, with 156 randomized to receive usual care and 149 to receive the intervention. At 18 months, there was no overall statistical or clinically significant change in the dyspnea domain in either group. However, for 6-minute-walk distance, there were statistically significant declines in both groups. In contrast, 6-minute-walk distance remained stable (5.3 m; P = 0.54) among patients in the intervention group with moderate spirometric impairment, but it was associated with clinically and statistically significant declines (-28.7 m; P = 0.0001) among usual care patients with moderate spirometric impairment. Overall, there was no increase in adverse events associated with the intervention, which was associated with a lower prevalence of hospitalization for COPD exacerbations (28.3%) compared with usual care (49.5%). CONCLUSIONS During this 18-month trial among outpatients with COPD, a health coach-based behavioral intervention did not improve scores in the dyspnea domain of the Chronic Respiratory Questionnaire or 6-minute-walk test distance. However, subgroup analyses suggested that there may be differential effects for specific outcomes that vary with severity of COPD. Specifically, benefits of this low-intensity intervention may be limited to 6-minute walk distance among patients with moderate spirometric impairment. Clinical trial registered with www.clinicaltrials.gov (NCT1108991).
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Pragmatic replication trial of health promotion coaching for obesity in serious mental illness and maintenance of outcomes.
Bartels, SJ, Pratt, SI, Aschbrenner, KA, Barre, LK, Naslund, JA, Wolfe, R, Xie, H, McHugo, GJ, Jimenez, DE, Jue, K, et al
The American journal of psychiatry. 2015;(4):344-52
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Abstract
OBJECTIVE Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population. METHOD Persons with serious mental illness and a body mass index (BMI) >25 receiving services in three community mental health organizations were recruited and randomly assigned either to the 12-month In SHAPE program, which included membership in a public fitness club and weekly meetings with a health promotion coach, or to fitness club membership alone. The primary outcome measures were weight and cardiorespiratory fitness (as measured with the 6-minute walk test), assessed at baseline and at 3, 6, 9, 12, and 18 months. RESULTS Participants (N=210) were ethnically diverse (46% were nonwhite), with a mean baseline BMI of 36.8 (SD=8.2). At 12 months, the In SHAPE group (N=104) had greater reduction in weight and improved fitness compared with the fitness club membership only group (N=106). Primary outcomes were maintained at 18 months. Approximately half of the In SHAPE group (51% at 12 months and 46% at 18 months) achieved clinically significant cardiovascular risk reduction (a weight loss ≥5% or an increase of >50 meters on the 6-minute walk test). CONCLUSIONS This is the first replication study confirming the effectiveness of a health coaching intervention in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness.
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Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: study protocol for a pragmatic randomised controlled trial.
Burton, E, Lewin, G, Clemson, L, Boldy, D
BMC health services research. 2013;:419
Abstract
BACKGROUND Restorative home care services help older people maximise their independence using a multi-dimensional approach. They usually include an exercise program designed to improve the older person's strength, balance and function. The types of programs currently offered require allocation of time during the day to complete specific exercises. This is not how the majority of home care clients prefer to be active and may be one of the reasons that few older people do the exercises regularly and continue the exercises post discharge.This paper describes the study protocol to test whether a Lifestyle Functional Exercise (LiFE) program: 1) is undertaken more often; 2) is more likely to be continued over the longer term; and, 3) will result in greater functional gains compared to a standard exercise program for older people receiving a restorative home care service. DESIGN A pragmatic randomised controlled trial (RCT) design was employed with two study arms: LiFE program (intervention) and the current exercise program (control). SETTING Silver Chain, a health and community care organisation in Perth, Western Australia. PARTICIPANTS One hundred and fifty restorative home care clients, aged 65 years and older. MEASUREMENTS The primary outcome is a composite measure incorporating balance, strength and mobility. Other outcome measures include: physical functioning, falls efficacy, and levels of disability and functioning. DISCUSSION If LiFE is more effective than the current exercise program, the evidence will be presented to the service management accompanied by the recommendation that it be adopted as the generic exercise program to be used within the restorative home care service. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry ACTRN12611000788976.