Impact of oral rehabilitation on the quality of life of partially dentate elders in a randomised controlled clinical trial: 2 year follow-up

IntroductionResistance training (RT) combined with aerobic training (AT) enhances the effects of cardiac rehabilitation (CR) in patients with coronary artery disease (CAD). However, it remains to be investigated which type of RT (high loads (HLs) vs low loads (LLs)) is more efficacious in improving exercise performance, cardio-metabolic health and quality of life.Methods and analysisA randomised, controlled, clinical trial will enrol 20 patients with CAD into each of three study arms (total 60 patients): HL-RT (70%–80% of one repetition maximum (1-RM)) combined with AT; LL-RT (30%–40% of 1-RM) combined with AT and AT alone as standard care. Primary outcomes (maximal aerobic capacity, maximal leg isometric strength) will be assessed at baseline and after 36 training sessions. Other outcomes will include acute haemodynamic responses to LL-RT and HL-RT, body composition, physical performance, blood biomarkers (lipids, glucose metabolism, inflammation, growth factors), physical activity and quality of life. The intention-to-treat principle will be used to analyse the data.Ethics and disseminationThe study design and protocol have been approved by the National Medical Ethics Committee of Slovenia (registration number: 0120-573/2019/15). The study will be conducted in accordance with the Declaration of Helsinki. The results of the study will be published as peer-reviewed manuscripts and congress presentations, communicated with patients and the clinical community, and shared through posts on social media. The findings of the study will be disseminated among the national CR clinical community (CR centres, Slovenian association of coronary clubs) with active participation of the patients enrolled in the study. This study will expand our knowledge of RT in combination with AT in CR. We expect to find different effects of HL-RT versus LL-RT, with implications for RT strategies in rehabilitation of patients with CAD.Trial registration numberNCT04638764.

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Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)

BMC Surgery ◽

10.1186/1471-2482-11-8 ◽

2011 ◽

Vol 11 (1) ◽

Cited By ~ 29

Author(s):

Nicole MA Krekel ◽

Barbara M Zonderhuis ◽

Hermien WH Schreurs ◽

Alexander MF Lopes Cardozo ◽

Herman Rijna ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Controlled Clinical Trial ◽

Ultrasound Guided ◽

Guided Surgery ◽

Randomised Controlled Clinical Trial ◽

Cosmetic Outcomes ◽

Randomised Controlled

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Randomised controlled clinical trial of stapled haemorrhoidectomy vs conventional haemorrhoidectomy; a three and a half year follow up

Colorectal Disease ◽

10.1111/j.1463-1318.2004.00496.x ◽

2004 ◽

Vol 6 (1) ◽

pp. 37-38 ◽

Cited By ~ 42

Author(s):

I. Au-Yong ◽

M. Rowsell ◽

D. M. Hemingway

Keyword(s):

Clinical Trial ◽

Controlled Clinical Trial ◽

Stapled Haemorrhoidectomy ◽

Randomised Controlled Clinical Trial ◽

Conventional Haemorrhoidectomy ◽

Randomised Controlled

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Follow-up after surgical treatment for intermittent claudication (FASTIC): a study protocol for a multicentre randomised controlled clinical trial

BMC Nursing ◽

10.1186/s12912-020-00437-7 ◽

2020 ◽

Vol 19 (1) ◽

Author(s):

Sara Haile ◽

Anneli Linné ◽

Unn-Britt Johansson ◽

Eva Joelsson-Alm

Keyword(s):

Clinical Trial ◽

Surgical Treatment ◽

Intermittent Claudication ◽

Study Protocol ◽

Controlled Clinical Trial ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled

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EFFECT OF ASPIRIN AND ASPIRIN COMBINED WITH DIPYRIDAMOLE IN EARLY DIABETIC RETINOPATHY

10.1055/s-0038-1643855 ◽

1987 ◽

Author(s):

M Samama ◽

C E Baudoin

Keyword(s):

Clinical Trial ◽

Diabetic Retinopathy ◽

Clinical Relevance ◽

Antiplatelet Agents ◽

Controlled Clinical Trial ◽

Double Blind ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled

In a double blind randomised controlled clinical trial the effect of antiplatelet agents (aspirin 330 mg × 3 × day) or in combination with dipyridamole (75 mg 3 × day) versus placebo, was tested in 475 patients with early diabetic retinopathy. Patients were follewed fourmonthly for 3 years. Ophtalmological examinations were carried out initially and at yearly intervals. The assessment of retinopathy was based on changes in the number of microaneurysms (MA) present in the macular field as seen on fluorescein angiograms over a period of three years. Forty one patients did not complete the study. Among the others at least three readable initial and yearly angiograms were available on 420 patients who had a 3 year follow up (266 insulin treated and 154 non insulin treated). The results are based on these patients.It is concluded that either Aspirin alone or in conjunction with dipyridamole significantly slows down the progression of MA evolution in early diabetic retinopathy. Because of the very small, although significant changes, the clinical relevance of these drugs has not been established.

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Visual and refractive outcomes and complications in femtosecond laser-assisted versus conventional phacoemulsification cataract surgery: findings from a randomised, controlled clinical trial

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-314548 ◽

2020 ◽

pp. bjophthalmol-2019-314548

Author(s):

Daliya Dzhaber ◽

Osama M Mustafa ◽

Fares Alsaleh ◽

Yassine J Daoud

Keyword(s):

Clinical Trial ◽

Visual Acuity ◽

Femtosecond Laser ◽

Cataract Surgery ◽

Controlled Clinical Trial ◽

Distance Visual Acuity ◽

Refractive Outcomes ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled

Background/aimTo compare visual and refractive outcomes, changes in intraocular pressure (IOP), and complications of femtosecond laser-assisted cataract surgery (FLACS) to conventional phacoemulsification surgery (CPS) in paired eyes from the same patients.MethodsThis is a secondary analysis of an intraindividual, randomised, controlled clinical trial including 110 paired eyes from 55 patients that were randomised into either FLACS or CPS groups. Outcomes were recorded at baseline and postoperatively during a 3-month follow-up period.ResultsUncorrected distance visual acuity and corrected distance visual acuity were similar between FLACS and CPS over the follow-up period (p>0.05). The mean absolute refractive error was not significantly different between the two groups at postoperative month 1 (POM1) (0.3±0.2 D in FLACS vs 0.4±0.3 D in CPS, p=0.18) and month 3 (POM3) (0.3±0.3 D in FLACS vs 0.3±0.3 D in CPS, p=0.71). IOP was statistically higher in the FLACS group on postoperative day 1 (20.6±5.7 mm Hg for FLACS and 18.0±4.9 mm Hg for CPS, p=0.01). However, it was similar between the two groups subsequently (p>0.05). Intraoperatively, one case of posterior capsular block syndrome was observed in the FLACS group. Postoperatively, one case of newly developed glaucoma was observed in the FLACS group and one case of retinal tears in the CPS group.ConclusionThe 3-month postoperative refractive and visual outcomes were comparable between FLACS and CPS in paired eyes from the same patients. Complication rate was low in the study population.

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