scholarly journals A double-blind, randomised, controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study

2021 ◽  
pp. 00077-2021
Author(s):  
Abdulelah M. Aldhahir ◽  
Yousef S. Aldabayan ◽  
Jaber S. Alqahtani ◽  
Heidi A. Ridsdale ◽  
Colette Smith ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Capacity ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Protein Supplementation ◽  
High Protein ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundPulmonary rehabilitation (PR) is a cost-effective management strategy in chronic obstructive pulmonary disease (COPD) which improves exercise performance and health-related quality of life. Nutritional supplementation may counter malnutrition and enhance PR outcomes but rigorous evidence is absent. We aimed to investigate the effect of high protein-supplementation (Fortisip Compact Protein, FCP) during PR on exercise capacity.MethodsA double-blind randomised controlled trial comparing FCP with preOp (a carbohydrate control supplement) in COPD patients participating in a PR programme. Participants consumed the supplement twice a day during PR and attended twice-weekly PR sessions, with pre- and post-PR measurements including the incremental shuttle walk test (ISWT) at 6-weeks as the primary outcome. Participants’ experience using supplements was assessed.ResultsSixty-eight patients were recruited; (FCP: 36 and control: 32). The trial was stopped early due to COVID-19. Although statistical significance was not reached, there was the suggestion of a clinically meaningful difference in ISWT at 6 weeks favouring the intervention group (intervention: 342 m±149; n=22 versus control: 305 m±148; n=22, p=0.1). Individuals who achieved an improvement in ISWT had larger mid-thigh circumference at baseline (responder: 62 cm±4 versus non-responder: 55 cm±6; p=0.006). 79% were satisfied with the taste and 43% would continue taking the FCP.ConclusionAlthough the data did not demonstrate a statistically significant difference in ISWT, high protein supplementation in COPD during PR may result in a clinically meaningful improvement in exercise capacity and was acceptable to patients. Large, adequately powered studies are justified.

scholarly journals 388Investigating the utility of the customised fetal growth chart: a pragmatic randomised controlled trial

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Kristen Gibbons ◽  
Michael Beckmann ◽  
Vicki Flenady ◽  
Glenn Gardenre ◽  
Peter Gray
Keyword(s):  
Randomised Controlled Trial ◽  
Fetal Growth ◽  
Primary Outcome ◽  
Adverse Pregnancy Outcome ◽  
Controlled Trial ◽  
Growth Chart ◽  
Singleton Pregnancy ◽  
Double Blind ◽  
Significant Difference ◽  
Randomised Controlled

Abstract Background To determine if the routine use of a customised fetal growth chart, when compared to a standard growth chart, reduces the risk of adverse pregnancy outcome through increased detection of adverse growth. Methods A double-blind, single centre, randomised controlled trial was conducted. All women with a singleton pregnancy receiving routine antenatal care through hospital clinics were included and randomised to either a standard growth chart (SC) or a customised growth chart (CC). Serial measurements of symphyseal fundal height (SFH) were plotted onto the chart in the electronic clinical record; pre-programmed alerts notified the clinician when growth or size required review. The primary outcome measure was a composite perinatal morbidity/mortality outcome. Results 3993 women were recruited; 45.4% nulliparous; 50.0% Caucasian, 17.8% Asian; 34.9% were overweight/obese prior to pregnancy; average 30 (SD 5.5) years old. The median (IQR) number of growth alerts was 2 (0-3) for both groups (p = 0.378); there was no difference in the total number of ultrasounds per pregnancy (median [IQR] 3 [2-4] for both groups, p = 0.266). There was no significant difference in primary composite outcome (CC 6.4%, SC 7.5%, p = 0.171) or individual components, apart from stillbirth (CC n = 1 0.05%, SC n = 8 0.4%, p = 0.039). Conclusions Use of a CC resulted in no difference in primary outcome, number of growth alerts or number of ultrasounds. Key messages In a large, pragmatic RCT use of a CC in conjunction with serial SFH measurements may infer some benefit over a SC, particularly in relation to stillbirth.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

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