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1.
Objective
To compare clinical pain intensity, exercise performance, pain sensitivity and the effect of aerobic and isometric exercise on local and remote pressure pain thresholds (PPTs) in patients with chronic musculoskeletal pain with high and low levels of kinesiophobia.Design
An experimental pre–post within-subject study.Setting
An exercise laboratory in a multidisciplinary pain clinic.Participants
Fifty-four patients with chronic musculoskeletal pain.Interventions
Acute aerobic and isometric leg exercises.Main outcome measures
Clinical pain intensity (numerical rating scale, range 0 to 10), Tampa Scale of Kinesiophobia, aerobic and isometric exercise performances (intensity and maximal voluntary contraction), and PPTs at local and remote body areas before and after exercise conditions.Results
Patients with a high degree of kinesiophobia demonstrated increased pain intensity compared with patients with a low degree of kinesiophobia [high degree of kinesiophobia: 7.3 (1.6) on NRS; low degree of kinesiophobia: 6.3 (1.6) on NRS; mean difference 1.0 (95% confidence interval 0.08 to 1.9) on NRS]. Aerobic and isometric exercises increased PPTs, but no significant group differences were found in PPTs before and after exercise.Conclusions
Clinical pain intensity was significantly higher in patients with a high degree of kinesiophobia compared with patients with a low degree of kinesiophobia. Despite a difference in isometric exercise performance, the hypoalgesic responses after cycling and isometric knee exercise were comparable between patients with high and low degrees of kinesiophobia. If replicated in larger studies, these findings indicate that although kinesiophobic beliefs influence pain intensity, they do not significantly influence PPTs and exercise-induced hypoalgesia in patients with chronic musculoskeletal pain. 相似文献2.
Purpose
The decline of central nervous system (CNS) function is a hallmark characteristic of multiple sclerosis (MS) that can manifest as cognitive impairment. We believe that exercise represents a potential behavioral approach for counteracting the declines in CNS structure and associated function among persons with MS (ie, exercise as a countermeasure of CNS decline). This theory is important because disease-modifying drugs represent a first-line approach for modifying the immune system and its effects on the CNS, but these drugs do not generally demonstrate robust improvements in cognitive performance.Methods
To the best of our knowledge, this article presents the first argument positioning exercise as a countermeasure for CNS decline in MS.Finding
The reviewed research indicates a proliferating body of evidence describing physical fitness, physical activity, and exercise effects on cognitive performance and neuroimaging outcomes (ie, CNS functioning) in MS, with the consistent and strong association between cognitive performance and neuroimaging outcomes in this population as a backdrop.Implications
We further present a framework and future research directions for better positioning exercise as a possible neuroprotective behavior against declining CNS function in MS. 相似文献3.
Purpose
The ability of sophisticated sensors and medical devices to monitor critical biomarkers has the potential to greatly advance precision medicine initiatives. A stakeholder event was organized to develop working models for the evolution of the field.Methods
A workshop devoted to the subject matter was held at the Tufts Clinical and Translational Science Institute involving clinicians, device developers, regulators, engineers, and scientists.Findings
Several areas for collaborative development were identified and interested teams offered resources for development of research programs.Implications
The diversity of relevant stakeholders presents a major opportunity and challenge in translational research. It is evident that the CTSI national network can take a leadership role in the rapidly advancing and potentially transformative field of digital biomarkers. 相似文献4.
Stefano Raffaele Giannubilo Angela Pasculli Chiara Ballatori Alessandra Biagini Andrea Ciavattini 《Clinical therapeutics》2018,40(4):587-592
Purpose
This was a prospective observational cohort study that aimed to determine whether fetal sex influences the maternal and fetal outcomes of gestational diabetes mellitus (GDM).Methods
In this study, 327 European primiparous women were consecutively recruited after diagnosis of GDM. AUC on the oral glucose tolerance test (OGTT), need for insulin therapy, maternal and obstetrical outcomes, and fetal fat mass (by measuring the thickness of the anterior abdominal subcutaneous tissue) were recorded and compared between the two subgroups of female and male fetuses.Findings
Despite the absence of differences in multiple comparisons of the OGTT, the AUC–OGTT was significantly higher in women carrying a male fetus (22.6 [3.2] mmol/L vs 19.7 [2.8] mmol/L). The abdominal fat thickness appeared to increase with gestational age, with higher growth in male fetuses than in female fetuses. The overall risk of need for insulin therapy was significantly higher in women carrying a male fetus (odds ratio = 1.837). At delivery, birthweight was higher in males than in females only if adjusted for gestational age, similarly for placental weight, otherwise there were no significant differences between the groups in total length of gestation, rates of cesarean delivery, and Apgar scores.Implications
Overall, our data propose an association between fetal sex and GDM outcomes, suggesting the hypothesis that in maternal–fetal interactions, the fetus can affect maternal glucose metabolism. 相似文献5.
Diana Gritsenko Marianna Fedorenko Jorg J. Ruhe Jerry Altshuler 《Clinical therapeutics》2017,39(1):212-218
Purpose
Although vancomycin has been the mainstay of therapy for methicillin-resistant Staphylococcus aureus (MRSA) infections, its effectiveness has been challenged. Combination therapy may be used for patients with persistent MRSA bacteremia refractory to initial therapy. Studies have reported in vitro synergy between vancomycin and ceftaroline; however, clinical experience with this therapy is limited. Here, we report our experience with 5 cases of vancomycin-refractory MRSA bacteremia treated with the combination of vancomycin and ceftaroline.Methods
Between January 2014 and August 2016, 5 patients were identified who received vancomycin and ceftaroline combination therapy due to persistent bacteremia or deterioration of their clinical status on vancomycin alone (despite a vancomycin MIC within the susceptible range).Findings
Five patients presented with MRSA bacteremia secondary to endocarditis (n = 2), epidural abscess (n = 2), or left iliopsoas abscess (n = 1). Four of the 5 patients experienced microbiologic cure, and 1 patient transitioned to palliative care.Implications
This case series serves to describe additional clinical experience with vancomycin and ceftaroline combination therapy. This combination may be considered when vancomycin monotherapy does not lead to microbiological and/or clinical improvement in patients with metastatic MRSA bacteremia. Additional studies are warranted to further define its role in salvage therapy for persistent MRSA bacteremia. 相似文献6.
Rahul P. Patel Jilson Jacob Mohammed Sedeeq Long Chiau Ming Troy Wanandy Syed Tabish R. Zaidi Gregory M. Peterson 《Clinical therapeutics》2018,40(4):664-667
Purpose
The aim was to investigate the stability of cefazolin in elastomeric infusion devices.Methods
Elastomeric devices (Infusor LV) that contain cefazolin (3 g/240 mL and 6 g/240 mL) were prepared and stored at 4°C for 72 hours and then at 35°C for 12 hours, followed by 25°C for 12 hours. An aliquot was withdrawn at predefined time points and analyzed for the concentration of cefazolin. Samples were also assessed for changes in pH, solution color, and particle content.Findings
Cefazolin retained acceptable chemical and physical stability over the studied storage period and conditions.Implications
These findings will allow the administration of cefazolin by the Infusor LV elastomeric device in the outpatient and remote settings. 相似文献7.
Kirstine Shrubsole Linda Worrall Emma Power Denise A. O&#x;Connor 《Archives of physical medicine and rehabilitation》2018,99(7):1413-1423.e24
Objective
To identify implementation priorities for poststroke aphasia management relevant to the Australian health care context.Data Sources
Using systematized searches of databases (CINAHL and MEDLINE), guideline and stroke websites, and other sources, evidence was identified and extracted for 7 implementation criteria for 13 topic areas relevant to aphasia management. These 7 priority-setting criteria were identified in the implementation literature: strength of the evidence, current evidence-practice gap, clinician preference, patient preference, modifiability, measurability, and health effect.Study Selection
Articles were included if they were in English, related to a specific recommendation requiring implementation, and contained information pertaining to any of the 7 prioritization criteria.Data Extraction
The scoping review methodology was chosen to address the broad nature of the topic. Evidence was extracted and placed in an evidence matrix. After this, evidence was summarized and then aphasia rehabilitation topics were prioritized using an approach developed by the research team.Data Synthesis
Evidence from 100 documents was extracted and summarized. Four topic areas were identified as implementation priorities for aphasia: timing, amount, and intensity of therapy; goal setting; information, education, and aphasia-friendly information; and constraint-induced language therapy.Conclusions
Closing the evidence-practice gaps in the 4 priority areas identified may deliver the greatest gains in outcomes for Australian stroke survivors with aphasia. Our approach to developing implementation priorities may be useful for identifying priorities for implementation in other health care areas. 相似文献8.
Jibril Mohammed Eric Derom Jessica Van Oosterwijck Hellen Da Silva Patrick Calders 《Physiotherapy》2018,104(1):36-45
Objective
To assess evidence for the effectiveness of aerobic exercise training (AET) on the autonomic function (AF) outcomes in patients with chronic obstructive pulmonary disease (COPD).Data sources
Online databases of PubMed, CINAHL and Web of Science were systematically searched for all years till 26th of January, 2017.Study selection
Clinical studies assessing any measure of AF following exercise training in patients with COPD were included.Data extraction and synthesis
Data were extracted from studies with high methodological quality for evidence synthesis. Rating of evidence quality was determined using the GRADE guidelines.Results
The Majority of the included studies utilized continuous exercise training mode with a vigorous level of intensity. Each exercise training session lasted between 30 to 40 minutes, and the frequency of intervention was ≥3 times/week. Evidence synthesis of studies with high methodological quality revealed that a high quality evidence level supported a significant increase for time-domain heart rate variability (HRV) analyses and the heart rate recovery (HRR) following AET. The review also found that frequency domain HRV analyses were not significantly affected by AET. The evidence to support the effect of exercise training on baroreceptor sensitivity (BRS) in patients with COPD is very low.Conclusion
Aerobic exercise training demonstrated beneficial but limited effects on the AF in COPD. Presently, it is not clear whether these effects are sustained in the long term. Only a limited number of RCTs were available indicating a significant gap in the literature. 相似文献9.
Wendy W. Yeh Iain P. Fraser Patricia Jumes Amelia Petry Inge De Lepeleire Martine Robberechts Christina Reitmann Kristien Van Dyck Xiaobi Huang Zifang Guo Deborah Panebianco Robert B. Nachbar Edward O’Mara John A. Wagner Joan R. Butterton Frank J. Dutko Valentin Moiseev Zhanna Kobalava Frank Wagner 《Clinical therapeutics》2018,40(5):704-718.e6
Purpose
Elbasvir (MK-8742) and grazoprevir (MK-5172; Merck & Co, Inc, Kenilworth, New Jersey) are hepatitis C virus (HCV)-specific inhibitors of the nonstructural protein 5A phosphoprotein and the nonstructural protein 3/4A protease, respectively. The aims of these studies were to evaluate the antiviral activity and safety of different doses of elbasvir or grazoprevir each administered as monotherapy to participants infected with either HCV genotype (GT) 1 or GT3.Methods
These 2 double-blind, randomized, placebo-controlled, sequential-panel, multiple ascending dose studies were conducted to assess the safety and pharmacodynamics of 5 days of once-daily elbasvir or 7 days of once-daily grazoprevir in adult male participants chronically infected with either HCV GT1 or GT3.Findings
Oral administration of elbasvir or grazoprevir once daily exhibited potent antiviral activity in participants with chronic GT1 or GT3 HCV infections. HCV RNA levels declined rapidly (within 1 day for elbasvir and 2 days for grazoprevir). At 50 mg of elbasvir once daily, the mean maximum reductions in HCV RNA from baseline were 5.21, 4.17, and 3.12 log10 IU/mL for GT1b-, GT1a-, and GT3-infected participants, respectively. At 100 mg of grazoprevir once daily, the mean maximum reductions in HCV RNA from baseline were 4.74 and 2.64 log10 IU/mL for GT1- and GT3-infected participants.Implications
The results in the elbasvir monotherapy study showed that 10 to 50 mg of elbasvir was associated with a rapid decline in HCV viral load; the results in the grazoprevir monotherapy study suggest that doses of 50 mg of grazoprevir and higher are on the maximum response plateau of the dose–response curve for GT1-infected participants. The results of these proof-of-concept studies provided preliminary data for the selection of the dosages of elbasvir and grazoprevir to test in Phase II and III clinical studies. ClinicalTrials.gov identifiers: NCT00998985 (Protocol 5172-004) and NCT01532973 (Protocol 8742-002). 相似文献10.
11.
Muserrefe Nur Keles Bulent Elbasan Umut Apaydin Zeynep Aribas Arzu Bakirtas Nurdan Kokturk 《Revista brasileira de fisioterapia (S?o Carlos (S?o Paulo, Brazil))》2018,22(6):493-501
Background
Respiratory muscle weakness and its relation to other impairments in children with cerebral palsy (CP) have been shown in the latest studies. The effects of inspiratory muscle training (IMT) in this population have not been comprehensively investigated so far.Objectives
To investigate the effects of IMT on trunk control, pulmonary functions, respiratory muscle strength, daily living activities, exercise capacity and quality of life in children with CP.Methods
This was a prospective-randomized controlled trial. Twenty-five children with CP were randomly assigned to the treatment (n = 13) or the control group (n = 12). The treatment group received IMT at 30% of maximal inspiratory pressure (MIP) and the control group received sham therapy (5% of MIP) for 6 weeks. Also, both groups received routine conventional physical therapy (stretching, strengthening, and functional exercises, etc.) for 6 weeks. The primary outcome measure was trunk control. Secondary outcome measures were pulmonary function, respiratory muscle strength, daily living activities, functional exercise capacity and quality of life.Results
The treatment group had better outcome for trunk control (3.87, 95% CI 3.72–4.02). Also, respiratory muscle strength, daily living activities, functional exercise capacity and quality of life were significantly improved in the treatment group compared with controls. No improvements were observed in the pulmonary function test scores between the groups.Conclusion
Inspiratory muscle training improves trunk control, respiratory muscle strength, daily living activities, functional exercise capacity and quality of life in children with CP and it can be included in the physiotherapy and rehabilitation programs. 相似文献12.
Mohit Kumar Adam Chapman Saad Javed Uazman Alam Rayaz A Malik Shazli Azmi 《Clinical therapeutics》2018,40(6):850-861
Purpose
This review provides an update on the investigations and treatment options for gastroparesis.Methods
A comprehensive literature search of Medline, PubMed, Embase and OVID was conducted which included all systematic reviews and research articles that focused on the diagnosis, investigations and management diabetic gastroparesis.Findings
Dietary modifications and pharmacologic treatment with prokinetics to increase gastric motility form the mainstay of treatment. However, the use of prokinetics is limited by adverse effects and serious adverse effects, leaving metoclopramide as the only drug approved by the US Food and Drug Administration for the treatment of gastroparesis. Newer therapies, including motilin receptor agonists, ghrelin receptor agonists, and neurokinin receptor antagonists, are currently being investigated. Transpyloric stenting, gastric electrical stimulation, and gastric per-oral endoscopic myotomy provide mechanical options for intervention, and surgical interventions in severe intractable gastroparesis include laparoscopic pyloroplasty or gastrectomy.Implications
Advances to better understand the pathophysiology and management of diabetic gastroparesis have been limited, especially with discordance between symptoms and severity of delay in gastric emptying. Established treatment options are limited; however, recent pharmacologic and surgical interventions show promise. 相似文献13.
14.
Zohaib Iqbal Shazli Azmi Rahul Yadav Maryam Ferdousi Mohit Kumar Daniel J. Cuthbertson Jonathan Lim Rayaz A. Malik Uazman Alam 《Clinical therapeutics》2018,40(6):828-849
Purpose
Diabetic peripheral neuropathy (DPN) is the commonest cause of neuropathy worldwide, and its prevalence increases with the duration of diabetes. It affects approximately half of patients with diabetes. DPN is symmetric and predominantly sensory, starting distally and gradually spreading proximally in a glove-and-stocking distribution. It causes substantial morbidity and is associated with increased mortality. The unrelenting nature of pain in this condition can negatively affect a patient's sleep, mood, and functionality and result in a poor quality of life. The purpose of this review was to critically review the current literature on the diagnosis and treatment of DPN, with a focus on the treatment of neuropathic pain in DPN.Methods
A comprehensive literature review was undertaken, incorporating article searches in electronic databases (EMBASE, PubMed, OVID) and reference lists of relevant articles with the authors' expertise in DPN. This review considers seminal and novel research in epidemiology; diagnosis, especially in relation to novel surrogate end points; and the treatment of neuropathic pain in DPN. We also consider potential new pharmacotherapies for painful DPN.Findings
DPN is often misdiagnosed and inadequately treated. Other than improving glycemic control, there is no licensed pathogenetic treatment for diabetic neuropathy. Management of painful DPN remains challenging due to difficulties in personalizing therapy and ascertaining the best dosing strategy, choice of initial pharmacotherapy, consideration of combination therapy, and deciding on defining treatment for poor analgesic responders. Duloxetine and pregabalin remain first-line therapy for neuropathic pain in DPN in all 5 of the major published guidelines by the American Association of Clinical Endocrinologists, American Academy of Neurology, European Federation of Neurological Societies, National Institute of Clinical Excellence (United Kingdom), and the American Diabetes Association, and their use has been approved by the US Food and Drug Administration.Implications
Clinical recognition of DPN is imperative for allowing timely symptom management to reduce the morbidity associated with this condition. 相似文献15.
Objective
To estimate the effectiveness of a 10-week combined exercise training and home-based walking programme on daily physical activity (PA) compared with standard medical care in patients with moderate chronic obstructive pulmonary disease (COPD).Design
Randomised controlled trial.Setting
Primary care physiotherapy.Participants
Consecutive patients with stable COPD at Gold Stage II with a score of two or more on the Medical Research Council Dyspnoea Scale.Intervention
Ten-week combined exercise training and home-based walking programme compared with standard medical care.Main outcomes
At baseline and after 10 weeks, daily PA was evaluated by accelerometry using three levels of intensity and expressed as metabolic equivalent of task. In addition, daily activities (Physical Activity Scale for the Elderly), functional exercise capacity (6-minute Walk Test), health-related quality of life (Chronic Respiratory Questionnaire) and exercise self-efficacy (Exercise Self-Regulatory Efficacy Scale) were measured.Results
Fifty-two patients {34 females; mean age 70.2 [standard deviation (SD) 9.5] years; mean forced expiratory volume in 1 second 67% (SD 9.2) of predicted} were randomised. PA, adjusted for baseline differences, increased significantly in the intervention group compared with the control group, by 26.1 minutes/day [95% confidence interval (CI) 7.3 to 44.9]. The increase in functional capacity between groups was clinically relevant (34.0 m, 95% CI 2.3 to 65.6) in favour of the intervention group.Conclusions
A combined exercise training and home-based walking programme in primary care physiotherapy improved PA in patients with moderate COPD.Clinical trial registration number NL24766.018.08. 相似文献16.
Effects of exercise training in water and on land in patients with COPD: a randomised clinical trial
J.M. Felcar V.S. Probst D.R. de Carvalho M.F. Merli R. Mesquita L.S. Vidotto L.R.G. Ribeiro F. Pitta 《Physiotherapy》2018,104(4):408-416
Objectives
To compare the effects of two similar 6-month protocols of high-intensity exercise training, in water and on land, in patients with chronic obstructive pulmonary disease (COPD).Design
Randomised controlled trial.Setting
University-based outpatient clinic.Participants
Thirty-six patients with predominantly moderate-to-severe COPD completed the study.Intervention
Patients were evaluated at baseline, at 3 months and at the end of the programme (i.e. 6 months). For both groups, the 6-month protocol consisted of high-intensity endurance and strength exercises with gradual increase in time and/or workload, totalling 60 sessions.Main outcomes
Objective monitoring of physical activity in daily life (PADL, primary outcome), lung function, peripheral and respiratory muscle strength, body composition, maximal and submaximal exercise capacity, functional status, quality of life, and symptoms of anxiety and depression.Results
After 6 months of training, a significant improvement in PADL was seen for both groups [mean difference (95% confidence interval): land group 993 (358 to 1628) steps/day; water group 1669 (404 to 2934) steps/day]. Significant improvements were also seen in inspiratory, expiratory and peripheral muscle strength; maximal and submaximal exercise capacity; quality of life and functional status for both groups. There were no significant improvements in lung function, body composition, and symptoms of anxiety and depression for either group. No difference was found in the magnitude of improvement between the two types of training for any outcome.Conclusion
High-intensity exercise training in water generates similar effects compared with training on land in patients with moderate-to-severe COPD, rendering it an equally beneficial therapeutic option for this population.Clinical trial registration number
NCT01691131. 相似文献17.
Objective
This systematic review to aimed to evaluate the effects of orthopaedic manual therapy (OMT) on pain, improving function, and physical performance in patients with knee osteoarthritis (OA).Data sources
Four databases (PubMed, Web of Science, CENTRAL, and CINAHL) were searched.Study selection
Trials were required to compare OMT alone or OMT in combination with exercise therapy, with exercise therapy alone or control.Data extraction
Data extraction and risk assessment were done by two independent reviewers. Outcome measures were visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, WOMAC function score, WOMAC global score, and stairs ascending-descending time.Results
Eleven randomized controlled trials were included (494 subjects), four of which had a PEDro score of 6 or higher, indicating adequate quality. The results of the meta-analysis indicated that reduction of VAS score in OMT compared with the control group was statistically insignificant (SDM: ?0.59; 95% CI: ?1.54 to ?0.36; P = 0.224). The reduction of VAS score in OMT compared with exercise therapy group was statistically significant (SDM: ?0.78; 95% CI: ?1.42 to ?0.17; P = 0.013). The reduction of WOMAC pain score in OMT compared with the exercise therapy group was statistically significant (SDM: ?0.79; 95% CI: ?1.14 to ?0.43; P = 0.001). Similarly, the reduction of WOMAC function score in OMT compared with the exercise therapy group was statistically significant (SDM: ?0.85; 95% CI: ?1.20 to ?0.50; P = 0.001). However, the reduction of WOMAC global score in OMT compared with the exercise therapy group was statistically insignificant (SDM: ?0.23; 95% CI: ?0.54 to ?0.09; P = 0.164). The reduction of stairs ascending-descending time in OMT compared with the exercise therapy group was statistically significant (SDM: ?0.88; 95% CI: ?1.48 to ?0.29; P = 0.004).Conclusions
This review indicated OMT compared with exercise therapy alone provides short-term benefits in reducing pain, improving function, and physical performance in patients with knee OA.Review registration
PROSPERO 2016:CRD42016032799. 相似文献18.
Purpose
The extent to which new drug developers can benefit financially from shorter development times has implications for development efficiency and innovation incentives. We provided a real-world example of such gains by using recent estimates of drug development costs and returns.Methods
Time and fee data were obtained on 5 single-source manufacturing projects. Time and fees were modeled for these projects as if the drug substance and drug product processes had been contracted separately from 2 vendors. The multi-vendor model was taken as the base case, and financial impacts from single-source contracting were determined relative to the base case.Findings
The mean and median after-tax financial benefits of shorter development times from single-source contracting were $44.7 million and $34.9 million, respectively (2016 dollars). The after-tax increases in sponsor fees from single-source contracting were small in comparison (mean and median of $0.65 million and $0.25 million).Implications
For the data we examined, single-source contracting yielded substantial financial benefits over multi-source contracting, even after accounting for somewhat higher sponsor fees. 相似文献19.
Purpose
Epithelial ovarian cancer (EOC) is the leading cause of gynecologic cancer death in the United States. Most patients will ultimately fail platinum-based chemotherapy and have the disease recur. Interest is increasing in the use of targeted therapies in the treatment of EOC. This review focuses on the current use of targeted therapeutics in EOC as well as future directions.Methods
A literature search of Medline and PubMed was conducted (January 2000–October 2017) to identify recent reports of targeted drugs in EOC.Findings
A wide range of targeted therapeutics is currently being used as both monotherapy and in combination in the treatment of EOC. Clinically, the most commonly used classes of drugs currently are antiangiogenics and poly (ADP-ribose) polymerase inhibitors. However, a number of drugs in varying stages in development target a wide range of biochemical pathways. Activity and response rates of these drugs vary greatly. Questions continue about combination drug therapy and appropriate patient selection.Implications
The use of targeted therapeutics in the treatment of EOC, both as monotherapy and in combination, will continue to expand as more mechanisms of tumorigenesis are identified. Multiple clinical trials of a wide range of targeted therapeutics are currently ongoing. Evidence-based selection of drug targets and appropriate patient populations will allow strategic application of targeted therapeutics. 相似文献20.
Matthew L. Stevens Chung-Wei C. Lin Mark J. Hancock Trish Wisby-Roth Jane Latimer Chris G. Maher 《Physiotherapy》2018,104(2):217-223
Background
Before beginning a large and complex trial it is considered good practice to run a pilot study to assess the feasibility and acceptability so that quality is maintained and resources are not wasted.Objective
To assesses the feasibility and acceptability of procedures for TOPS: Trial Of Prevention Strategies for low back pain.Design
Randomised controlled pilot trial.Methods
This is a trial of an 8 week, physiotherapist-led group exercise and education program for preventing recurrence of low back pain (LBP) in those recently recovered from LBP. We assessed the feasibility of recruitment and data-collection procedures, acceptability of the trial interventions and loss-to-follow up.Results
The feasibility of recruitment, acceptability of the intervention and feasibility of physical activity data-collection procedures were all below anticipated levels. We enrolled 12 participants over 44 weeks, the adherence rate for the intervention group was 63% and valid physical activity data were obtained for 67% of the measurements. Follow-up methods for collection of LBP recurrence were successful with this information able to be collected for 100% of participants.Conclusion
In response to the pilot, modifications were made to the main trial protocol. We will increase recruitment by relaxing inclusion criteria and expanding recruitment sites to include workplaces, community centres and via social media. We will facilitate compliance by expanding treatment sites to provide more options for participants to access the program and we will limit missing data by checking the validity of baseline physical activity measures prior to enrolment.Trial registration: The study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ref: ACTRN12614000706673). 相似文献