scholarly journals Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034304 ◽  
Author(s):  
Maria Pilar López-Royo ◽  
Eva Maria Gómez-Trullén ◽  
Maria Ortiz-Lucas ◽  
Rita Maria Galán-Díaz ◽  
Ana Vanessa Bataller-Cervero ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Eccentric Exercise ◽  
Short Form ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Patellar Tendinopathy ◽  
Ultrasound Images ◽  
Perceived Quality Of Life ◽  
Randomised Controlled

IntroductionPatellar tendinopathy is a degenerative disease of the patellar tendon, which affects athletes from a variety of sports, and is especially predominant in sports involving high-impact jumping. The aim of this study is to determine the additional effect of two interventions combined with eccentric exercise and compare which one is the most effective at short-term and long-term follow-up for patients with patellar tendinopathy.Methods and analysisThis study is a randomised controlled trial with blinded participants. Measurements will be carried out by a specially trained blinded assessor. A sample of 57 patients with a medical diagnosis of patellar tendinopathy will participate in this study and will be divided into three treatment groups. Eligible participants will be randomly allocated to receive either: (a) treatment group with percutaneous needle electrolysis, (b) treatment group with dry needling or (c) treatment group with placebo needling. In addition, all groups will perform eccentric exercise. Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively. Participants will be assessed at baseline, at 10 weeks and at 22 weeks after baseline. The expected findings will allow us to advance in the treatment of this injury, as they will help determine whether a needling intervention has additional effects on an eccentric exercise programme and whether any of the needling modalities is more effective than the other.Ethics and disseminationThis protocol has been approved by the Ethics Committee of Aragon (N° PI15/0017). The trial will be conducted in accordance with the Declaration of Helsinki.Trial registration numberNCT02498795

scholarly journals Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036194 ◽  
Author(s):  
Beatrice Pettersson ◽  
Lillemor Lundin-Olsson ◽  
Dawn A Skelton ◽  
Per Liv ◽  
Magnus Zingmark ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Community Dwelling ◽  
Falls Prevention ◽  
Ethical Review ◽  
Exercise Interventions ◽  
Educational Videos ◽  
Randomised Controlled

IntroductionExercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults.Methods and analysisA two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30 min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30 s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle.Ethics and disseminationEthical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations’ newsletters.Trial registration numberNCT03963570.

scholarly journals Drainage, irrigation and fibrinolytic therapy (DRIFT) for posthaemorrhagic ventricular dilatation: 10-year follow-up of a randomised controlled trial

2020 ◽  
Vol 105 (5) ◽  
pp. 466-473 ◽  
Author(s):  
Karen Luyt ◽  
Sally L Jary ◽  
Charlotte L Lea ◽  
Grace J. Young ◽  
David E Odd ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Fibrinolytic Therapy ◽  
Ventricular Dilatation ◽  
Cognitive Disability ◽  
Randomised Controlled ◽  
Standard Treatment Group

BackgroundProgressive ventricular dilatation after intraventricular haemorrhage (IVH) in preterm infants has a very high risk of severe disability and death. Drainage, irrigation and fibrinolytic therapy (DRIFT), in a randomised controlled trial (RCT), reduced severe cognitive impairment at 2 years.ObjectiveTo assess if the cognitive advantage of DRIFT seen at 2 years persisted until school age.ParticipantsThe RCT conducted in four centres recruited 77 preterm infants with IVH and progressive ventricular enlargement over specified measurements. Follow-up was at 10 years of age.InterventionIntraventricular injection of a fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device.Primary outcomeCognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability.ResultsOf the 77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up. 28 in the DRIFT group and 24 in the standard treatment group were assessed by examiners blinded to the intervention. The mean CQ score was 69.3 (SD=30.1) in the DRIFT group and 53.7 (SD=35.7) in the standard treatment group (unadjusted p=0.1; adjusted p=0.01, after adjustment for the prespecified variables sex, birth weight and IVH grade). Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).ConclusionDRIFT is the first intervention for posthaemorrhagic ventricular dilatation to objectively demonstrate sustained cognitive improvement.Trial registration numberISRCTN80286058.

scholarly journals Feasibility and Health Effects of a 15-Week Combined Exercise Programme for Sedentary Elderly: A Randomised Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Tina-Thea Nielsen ◽  
Trine K. Møller ◽  
Lars L. Andersen ◽  
Mette K. Zebis ◽  
Peter R. Hansen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health Effects ◽  
Aerobic Fitness ◽  
Exercise Intensity ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Supervised Training ◽  
Home Based ◽  
Total Fat ◽  
Randomised Controlled

There is strong evidence that considerable health benefits can be achieved even with small amounts of physical activity. However, getting people to exercise regularly is a major challenge not least in the elderly population. This study investigated the feasibility and physiological health effects of a pragmatic 15-week exercise programme for sedentary elderly. In a single-blind randomised controlled trial, 45 sedentary 60-83-year-olds (25 women, 20 men) were randomly assigned (2:1 ratio) to a training group (TG, n=30) or a control group (CG, n=15). The training in TG consisted of a combination of exercise modalities (i.e., strength, aerobic fitness, stability, and flexibility training) performed once a week as supervised group-based training and a weekly home-based training for 15 weeks. Feasibility outcomes were exercise intensity, adherence, and adverse events. The primary outcome was change in aerobic fitness (VO2max/kg). Adherence was high (81%) for the supervised exercise and low (0%) for the home-based exercise. No acute injuries occurred in TG, but 4 subjects (13%) reported considerable joint pain related to training. Average heart rate (HR) during the supervised training was 104±12 beats/min (69.3±8.0%HRmax), with 3.9±7.3% of training time >90%HRmax. Intention-to-treat analyses revealed no between-group differences for aerobic fitness (P=0.790) or any secondary cardiovascular outcomes at 15-week follow-up (resting HR or blood pressure; P>0.05). Compared to CG, bodyweight (-2.3 kg, 95% CI -4.0 to -7.0; P=0.006), total fat mass (-2.0 kg, 95% CI -3.5 to -0.5; P=0.01), and total fat percentage (-1.6%, 95% CI -2.8 to -0.3; P=0.01) decreased in TG. The group-based supervised training had high adherence and moderate exercise intensity, whereas the home-based training was not feasible in this study population. This exercise programme performed once a week did not improve aerobic fitness. Thus, supervised training with more vigorous intensity control appears advisable. Clinical Study registration number is H-15016951.

scholarly journals Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e023162
Author(s):  
Jilin Chen ◽  
Ying Liu ◽  
Xiangmei Chen ◽  
Xuefeng Sun ◽  
Wei Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Medical Costs ◽  
Dialysis Initiation ◽  
Fuzzy Mathematics ◽  
Late Start ◽  
Randomised Controlled

IntroductionStarting dialysis early or late both result in a low quality of life and a poor prognosis in patients undergoing haemodialysis. However, there remains no consensus on the optimal timing of dialysis initiation, mainly because of a lack of suitable methods to assess variations in dialysis initiation time. We have established a novel equation named DIFE (Dialysis Initiation based on Fuzzy-mathematics Equation) through a retrospective, multicentre clinical cohort study in China to determine the most suitable timing of dialysis initiation. The predictors of the DIFE include nine biochemical markers and clinical variables that together influence dialysis initiation. To externally validate the clinical accuracy of DIFE, we designed the assessment of DIFE (ADIFE) study as a prospective, open-label, multicentre, randomised controlled trial to assess the clinical outcomes among patients who initiate dialysis in an optimal start dialysis group and a late-start dialysis group, based on DIFE.Methods and analysisA total of 388 enrolled patients with end-stage renal disease will be randomised 1:1 to the optimal start dialysis group, with a DIFE value between 30 and 35, or the late-start dialysis group, with a DIFE value less than 30, using the Randomization and Trial Supply Management system. Participants will be assessed for changes in signs and symptoms, dialysis mode and parameters, biochemical and inflammatory markers, Subjective Global Assessment, Kidney Disease Quality of Life Short Form, Cognitive Assessment, medical costs, adverse events and concomitant medication at baseline, predialysis visiting stage and postdialysis visiting stage, every 12–24 weeks. The following data will be recorded on standardised online electronic case report forms. The primary endpoint is 3-year all-cause mortality. The secondary endpoints include non-fatal cerebrocardiovascular events, annual hospitalisation rate, quality of life, medical costs and haemodialysis related complications.Ethics and disseminationEthical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Dalian Medical University China (registration no: YJ-KY-2017–119) and the ethics committees of all participating centres. The final results of the ADIFE trial will be presented to the study sponsor, clinical researchers and the patient and public involvement reference group. Findings will be disseminated through peer-reviewed journals, Clinical Practice Guidelines and at scientific meetings.Trial registration numberClinicalTrial.gov. Registry (NCT03385902); pre-results.

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