Browsing by Subject "RCT"

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  • Linkens, Armand M. A.; van Best, Niels; Niessen, Petra M.; Wijckmans, Nicole E. G.; de Goei, Erica E. C.; Scheijen, Jean L. J. M.; van Dongen, Martien C. J. M.; van Gool, Christel C. J. A. W.; de Vos, Willem M.; Houben, Alfons J. H. M.; Stehouwer, Coen D. A.; Eussen, Simone J. M. P.; Penders, John; Schalkwijk, Casper G. (2022)
    Dietary advanced glycation endproducts (AGEs), abundantly present in Westernized diets, are linked to negative health outcomes, but their impact on the gut microbiota has not yet been well investigated in humans. We investigated the effects of a 4-week isocaloric and macronutrient-matched diet low or high in AGEs on the gut microbial composition of 70 abdominally obese individuals in a double-blind parallel-design randomized controlled trial (NCT03866343). Additionally, we investigated the cross-sectional associations between the habitual intake of dietary dicarbonyls, reactive precursors to AGEs, and the gut microbial composition, as assessed by 16S rRNA amplicon-based sequencing. Despite a marked percentage difference in AGE intake, we observed no differences in microbial richness and the general community structure. Only the Anaerostipes spp. had a relative abundance >0.5% and showed differential abundance (0.5 versus 1.11%; p = 0.028, after low- or high-AGE diet, respectively). While the habitual intake of dicarbonyls was not associated with microbial richness or a general community structure, the intake of 3-deoxyglucosone was especially associated with an abundance of several genera. Thus, a 4-week diet low or high in AGEs has a limited impact on the gut microbial composition of abdominally obese humans, paralleling its previously observed limited biological consequences. The effects of dietary dicarbonyls on the gut microbiota composition deserve further investigation.
  • Terevnikov, Viacheslav; Stenberg, Jan-Henry; Tiihonen, Jari; Burkin, Mark; Joffe, Grigori (2017)
    Aim: Sexual dysfunction, common in schizophrenia, may be further exaggerated by antipsychotics, especially those of First Generation (FGAs), and antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRs). Mirtazapine, an antidepressant characterized by its different action mechanism compared with that of the majority of other antidepressants, may improve SSRI-induced sexual dysfunction in patients with depression. It is unknown, however, whether mirtazapine improves sexual functioning in schizophrenia.Methods: This study randomly assigned FGA-treated patients with schizophrenia to receive either an add-on mirtazapine (n=20) or a placebo (n=19) for 6 weeks. Sexual functioning was prospectively measured using five relevant items from the Udvalg for Kliniske Undersogelser side-effect rating scale (UKU-SERS).Results: Orgasmic function improved with statistical significance in the mirtazapine group (p=.03), with no changes in any other sexual functions in either group.Conclusion: Add-on mirtazapine appears to relieve orgasmic dysfunction in FGA-treated patients with schizophrenia.
  • Rantonen, J.; Karppinen, J.; Vehtari, A.; Luoto, S.; Viikari-Juntura, E.; Hupli, M.; Malmivaara, A.; Taimela, S. (2016)
    Background: Evidence shows that low back specific patient information is effective in sub-acute low back pain (LBP), but effectiveness and cost-effectiveness (CE) of information in early phase symptoms is not clear. We assessed effectiveness and CE of patient information in mild LBP in the occupational health (OH) setting in a quasi-experimental study. Methods: A cohort of employees (N = 312, aged Results: Compared to NC, the Booklet reduced HC costs by 196(sic) and SA by 3.5 days per year. In 81 % of the bootstrapped cases the Booklet was both cost saving and effective on SA. Compared to NC, in the Combined arm, the figures were 107(sic), 0.4 days, and 54 %, respectively. PHI decreased in both interventions. Conclusions: Booklet information alone was cost-effective in comparison to natural course of mild LBP. Combined information reduced HC costs. Both interventions reduced physical impairment. Mere booklet information is beneficial for employees who report mild LBP in the OH setting, and is also cost saving for the health care system.
  • Luokkala, Toni; Laitinen, Minna K.; Hevonkorpi, Teemu P.; Raittio, Lauri; Mattila, Ville M.; Launonen, Antti P. (2020)
    We found no clear evidence of the clinical superiority of distal radius fracture surgery among older adults at one year.Surgical treatment, however, may yield a faster recovery to previous level of activity in elderly patients.With operative treatment, hardware-based problems may warrant secondary operations and implant removal, whereas in non-operative treatment, symptomatic loss of alignment and malunion can occur.In elderly patients, non-operative treatment can be considered to be the gold standard.
  • Multanen, J.; Rantalainen, T.; Kautiainen, H.; Ahola, R.; Jamsa, T.; Nieminen, M. T.; Lammentausta, E.; Hakkinen, A.; Kiviranta, I.; Heinonen, A. (2017)
    It is uncertain whether subjects with mild knee osteoarthritis, and who may be at risk of osteoporosis, can exercise safely with the aim of improving hip bone strength. This RCT showed that participating in a high-impact exercise program improved femoral neck strength without any detrimental effects on knee cartilage composition. No previous studies have examined whether high-impact exercise can improve bone strength and articular cartilage quality in subjects with mild knee osteoarthritis. In this 12-month RCT, we assessed the effects of progressive high-impact exercise on femoral neck structural strength and biochemical composition of knee cartilage in postmenopausal women. Eighty postmenopausal women with mild knee radiographic osteoarthritis were randomly assigned into the exercise (n = 40) or control (n = 40) group. Femoral neck structural strength was assessed with dual-energy X-ray absorptiometry. The knee cartilage region exposed to exercise loading was measured by the quantitative MRI techniques of T2 mapping and delayed gadolinium-enhanced MRI of cartilage (dGEMRIC). Also, an accelerometer-based body movement monitor was used to evaluate the total physical activity loading on the changes of femoral neck strength in all participants. Training effects on the outcome variables were estimated by the bootstrap analysis of covariance. A significant between-group difference in femoral neck bending strength in favor of the trainees was observed after the 12-month intervention (4.4%, p <0.01). The change in femoral neck bending strength remained significant after adjusting for baseline value, age, height, and body mass (4.0%, p = 0.020). In all participants, the change in bending strength was associated with the total physical activity loading (r = 0.29, p = 0.012). The exercise participation had no effect on knee cartilage composition. The high-impact training increased femoral neck strength without having any harmful effect on knee cartilage in women with mild knee osteoarthritis. These findings imply that progressive high-impact exercise is a feasible method in seeking to prevent hip fractures in postmenopausal women whose articular cartilage may also be frail.
  • Rantonen, J.; Karppinen, J.; Vehtari, A.; Luoto, S.; Viikari-Juntura, E.; Hupli, M.; Malmivaara, A.; Taimela, S. (2018)
    Background: We assessed the effectiveness of three interventions that were aimed to reduce non-acute low back pain (LBP) related symptoms in the occupational health setting. Methods: Based on a survey (n = 2480; response rate 71%) on LBP, we selected a cohort of 193 employees who reported moderate LBP (Visual Analogue Scale VAS > 34 mm) and fulfilled at least one of the following criteria during the past 12 months: sciatica, recurrence of LBP >= 2 times, LBP >= 2 weeks, or previous sickness absence. A random sample was extracted from the cohort as a control group (Control, n = 50), representing the natural course of LBP. The remaining 143 employees were invited to participate in a randomised controlled trial (RCT) of three 1:1:1 allocated parallel intervention arms: multidisciplinary rehabilitation (Rehab, n = 43); progressive exercises (Physio, n = 43) and self-care advice (Advice, n = 40). Seventeen employees declined participation in the intervention. The primary outcome measures were physical impairment (PHI), LBP intensity (Visual Analogue Scale), health related quality of life (QoL), and accumulated sickness absence days. We imputed missing values with multiple imputation procedure. We assessed all comparisons between the intervention groups and the Control group by analysing questionnaire outcomes at 2 years with ANOVA and sickness absence at 4 years by using negative binomial model with a logarithmic link function. Results: Mean differences between the Rehab and Control groups were - 3 [95% CI -5 to - 1] for PHI, - 13 [- 24 to - 1] for pain intensity, and 0.06 [0.00 to 0.12] for QoL. Mean differences between the Physio and Control groups were - 3 [95% CI -5 to - 1] for PHI, -13 [- 29 to 2] for pain intensity, and 0.07 [0.01 to 0.13] for QoL. The main effects sizes were from 0.4 to 0.6. The interventions were not effective in reducing sickness absence. Conclusions: Rehab and Physio interventions improved health related quality of life, decreased low back pain and physical impairment in non-acute, moderate LBP, but we found no differences between the Advice and Control group results. No effectiveness on sickness absence was observed.
  • Rantonen, J.; Karppinen, J.; Vehtari, A.; Luoto, S.; Viikari-Juntura, E.; Hupli, M.; Malmivaara, A.; Taimela, S. (BioMed Central, 2018)
    Abstract Background We assessed the effectiveness of three interventions that were aimed to reduce non-acute low back pain (LBP) related symptoms in the occupational health setting. Methods Based on a survey (n = 2480; response rate 71%) on LBP, we selected a cohort of 193 employees who reported moderate LBP (Visual Analogue Scale VAS > 34 mm) and fulfilled at least one of the following criteria during the past 12 months: sciatica, recurrence of LBP ≥ 2 times, LBP ≥ 2 weeks, or previous sickness absence. A random sample was extracted from the cohort as a control group (Control, n = 50), representing the natural course of LBP. The remaining 143 employees were invited to participate in a randomised controlled trial (RCT) of three 1:1:1 allocated parallel intervention arms: multidisciplinary rehabilitation (Rehab, n = 43); progressive exercises (Physio, n = 43) and self-care advice (Advice, n = 40). Seventeen employees declined participation in the intervention. The primary outcome measures were physical impairment (PHI), LBP intensity (Visual Analogue Scale), health related quality of life (QoL), and accumulated sickness absence days. We imputed missing values with multiple imputation procedure. We assessed all comparisons between the intervention groups and the Control group by analysing questionnaire outcomes at 2 years with ANOVA and sickness absence at 4 years by using negative binomial model with a logarithmic link function. Results Mean differences between the Rehab and Control groups were − 3 [95% CI -5 to − 1] for PHI, − 13 [− 24 to − 1] for pain intensity, and 0.06 [0.00 to 0.12] for QoL. Mean differences between the Physio and Control groups were − 3 [95% CI -5 to − 1] for PHI, − 13 [− 29 to 2] for pain intensity, and 0.07 [0.01 to 0.13] for QoL. The main effects sizes were from 0.4 to 0.6. The interventions were not effective in reducing sickness absence. Conclusions Rehab and Physio interventions improved health related quality of life, decreased low back pain and physical impairment in non-acute, moderate LBP, but we found no differences between the Advice and Control group results. No effectiveness on sickness absence was observed. Trial registration Number NCT00908102 Clinicaltrials.gov
  • Natri, Ossi (Helsingin yliopisto, 2022)
    Coronary heart disease is a number one killer in westernized countries and the costs from it will continue to grow in the future. It is caused by atherosclerosis, build-up of plaque and chronic inflammation in the arteries of heart, and endogenous lipoproteins have a special role in its development. Among other atheroprotective properties, High density lipoproteins (HDL) have a role in intrinsic mechanism of the reverse cholesterol transport (RCT), of gathering and removing excess cholesterol from peripheral tissues. There have been several HDL raising strategies in the past for the treatment of atherosclerosis, but their success has been modest. Synthetic HDL (sHDL), comprising of various types of phospholipids and proteins or peptides, have been developed to mimic the properties of endogenous HDL. Despite some success in animal studies, failures in clinical studies have turned the focus on the HDL’s interaction with a specific enzyme lecithin:cholesterol acyl transferase (LCAT), responsible for cholesterol esterification, a key step in RCT. ApoA-I, the most abundant protein component of HDL, acts as LCAT cofactor in cholesterol esterification, and many LCAT activating peptides have been developed to mimic the features of apoA-I. The molecular level understanding behind LCAT activation is however still foggy. During enzymatic activation, LCAT goes through conformational changes specific regions, which are generated by interactions with apoA-I or synthetic peptides. These mechanisms have been studied widely with molecular dynamic simulations, in vitro experiments, and imaging. In this study, we investigated 22A (PVLDLFRELLNELLEALKQKLK), apoA-I mimetic peptide known for its as good LCAT activation potency as apoA-I, and four variations of it (21A, 22A-P, 22A-K22Q, and 22A-R7Q), and combined them with phospholipid DPPC to create sHDL nanodiscs by thermal cycling method. We examined the effect of small changes in peptide sequence on LCAT-sHDL binding strength with quartz crystal microbalance with dissipation (QCM-D). The interest was to further test the suitability of thermal cycling method on nanodisc assembly, test the binding strengths against the hypothesis of the role of salt-bridge forming amino acids R7 and K22 in peptide dimerization and its effect on LCAT binding and activation, and to see if QCM could act as a suitable method for the research of sHDL-LCAT interactions. All peptides formed similar sized sHDL particles with diameter of ~10 nm with thermal cycling method. As expected, the LCAT binding tendency of 22A-sHDL was highest, about double compared to four other peptide nanodiscs with almost identical results. The QCM results suggest that binding tendency between LCAT and sHDL is affected by small, one amino acid change in peptide sequence, but it does not necessarily have a big impact on LCAT’s esterification activity, but based on this experiment alone, we cannot make any further conclusions. Electron microscopy revealed exceptional breakdown of 21A-sHDL incubated with LCAT compared to 22A-sHDL. This phenomenon could indicate high lipolytic rate of LCAT but needs further investigation. There were some challenges with the measurement parameters in the beginning, and the variability between parallel measurements with QCM-D was high, which cause a little doubt about the method’s suitability for these kinds of precise measurements. More research for revealing the molecular mechanism behind LCAT activation is needed for the development of more effective treatments.
  • Holi, Matti M.; Eronen, Markku; Toivonen, Kari; Toivonen, Päivi; Marttunen, Mauri; Naukkarinen, Hannu (2004)
    In a double-blind, controlled study, we examined the therapeutic effects of high-frequency left prefrontal repetitive transcranial magnetic stimulation (rTMS) on schizophrenia symptoms. A total of 22 chronic hospitalized schizophrenia patients were randomly assigned to 2 weeks (10 sessions) of real or sham rTMS. rTMS was given with the following parameters: 20 trains of 5-second 10-Hz stimulation at 100 percent motor threshold, 30 seconds apart. Effects on positive and negative symptoms, self-reported symptoms, rough neuropsychological functioning, and hormones were assessed. Although there was a significant improvement in both groups in most of the symptom measures, no real differences were found between the groups. A decrease of more than 20 percent in the total PANSS score was found in 7 control subjects but only 1 subject from the real rTMS group. There was no change in hormone levels or neuropsychological functioning, measured by the MMSE, in either group. Left prefrontal rTMS (with the used parameters) seems to produce a significant nonspecific effect of the treatment procedure but no therapeutic effect in the most chronic and severely ill schizophrenia patients.
  • Kangaslampi, Samuli; Garoff, Ferdinand; Peltonen, Kirsi (2015)
    Background: Millions of children worldwide suffer from posttraumatic stress disorder (PTSD) symptoms and other mental health problems due to repeated exposure to war or organized violence. Forms of cognitive-behavioral therapy (CBT) are the most commonly used treatment for PTSD and appear to be effective for children as well, but little is known about the mechanisms of change through which they achieve their effectiveness. Here we present the study protocol of a randomized controlled trial (RCT) studying the effectiveness and mechanisms of change of Narrative Exposure Therapy (NET), a CBT-based, manualized, short-term intervention for PTSD symptoms resulting from repeated traumatization, in immigrant children traumatized by war. Methods/Design: We are conducting a multicentre, pragmatic RCT in a usual care setting. Up to 80 9-17-year-old immigrant children who have experienced war and suffer from PTSD symptoms will be randomized into intervention (NET) and control (treatment as usual, TAU) groups of equal sizes. The effectiveness of NET treatment will be compared to both a waiting list and the parallel TAU positive control group, on the primary outcomes of PTSD and depressive symptoms, psychological distress, resilience, and level of cognitive performance. The effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness. The possible moderating effects of peritraumatic dissociation, level of cognitive performance, and gender on treatment effectiveness will also be considered. We hypothesize that NET will be more effective than a waitlist condition or TAU in reducing PTSD and other symptoms and improving resilience, and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions. Discussion: The results of this trial will provide evidence for the effectiveness of NET in treating trauma-related symptoms in immigrant children affected by war. The trial will also generate insights into the complex relationships between PTSD, memory functions, posttraumatic cognitions and cognitive performance in children, and help guide the future development and implementation of therapeutic interventions for PTSD in children.
  • Leskinen, Tuija; Suorsa, Kristin; Tuominen, Miika; Pulakka, Anna; Pentti, Jaana; Löyttyniemi, Eliisa; Heinonen, Ilkka; Vahtera, Jussi; Stenholm, Sari (2021)
    Purpose The randomized controlled trial REACT (NCT03320746) examined the effect of a 12-month consumer-based activity tracker intervention on accelerometer-measured physical activity among recent retirees. Methods Altogether 231 recently retired Finnish adults (age, 65.2 +/- 1.1 yr, mean +/- SD; 83% women) were randomized to intervention and control groups. Intervention participants were requested to wear a commercial wrist-worn activity tracker (Polar Loop 2; Polar, Kempele, Finland) for 12 months, to try to reach the daily activity goals shown on the tracker display, and to upload their activity data to a Web-based program every week. The control group received no intervention. Accelerometer-based outcome measurements of daily total, light physical activity (LPA), and moderate to vigorous (MVPA) physical activity were conducted at baseline and at 3-, 6-, and 12-month time points. Hierarchical linear mixed models were used to examine the differences between the groups over time. All analyses were performed by intention-to-treat principle and adjusted for wake wear time. Results The use of a commercial activity tracker did not increase daily total activity, LPA, or MVPA over the 12-months period when compared with nonuser controls (group-time interaction, P = 0.39, 0.23, and 0.77, respectively). There was an increase in LPA over the first 6 months in both the intervention (26 min center dot d(-1), 95% confidence interval [CI] = 13 to 39) and the control (14 min center dot d(-1), 95% CI = 1 to 27) groups, but the difference between the groups was not significant (12 min center dot d(-1), 95% CI = -6 to 30). In both groups, LPA decreased from 6 to 12 months. Conclusion The 12-month use of a commercial activity tracker does not appear to elicit significant changes in the daily total activity among a general population sample of recent retirees, thus highlighting the need to explore other alternatives to increase physical activity in this target group.