scholarly journals Effect of Eight-Week Online Cognitive Training in Parkinson’s Disease: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Tim D. van Balkom ◽  
Henk W. Berendse ◽  
Ysbrand D. van der Werf ◽  
Jos W.R. Twisk ◽  
Carel F.W. Peeters ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Processing Speed ◽  
Mixed Model ◽  
Controlled Trial ◽  
Tower Of London ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Subjective Cognitive Complaints

AbstractBackgroundCognitive training (CT) has been proposed as a non-pharmacological treatment option for the frequent cognitive impairments occurring in PD.ObjectiveAssess the efficacy of CT on cognitive function in PD.MethodsIn this double-blind, randomized controlled trial we enrolled 140 PD patients with significant subjective cognitive complaints. In eight weeks, participants underwent 24 sessions of computerized multi-domain CT or an active control condition for 45 minutes each (n=70 vs. n=70). The primary outcome was the accuracy on a computerized Tower of London task; secondary outcomes included effects on other neuropsychological outcomes and subjective cognitive complaints. Outcomes were assessed before and after training and at six-months follow-up, and were analyzed with multivariate mixed-model analyses.ResultsThe intention-to-treat population consisted of 136 participants. Multivariate mixed-model analyses showed no group difference on the Tower of London accuracy corrected for baseline performance: B: −0.06, 95% CI: −0.27 to 0.15, p=0.562. Participants in the CT group were on average 0.30 SD (i.e., 1.5 seconds) faster on the Tower of London, difficulty load 4 (secondary outcome): 95% CI: −0.55 to −0.06, p=0.015. CT had similar positive effects on other processing speed-related executive function tasks, although these did not reach statistical significance. At follow-up, no group differences were present.ConclusionsThe results show tentative but consistent positive effects of CT on processing speed during executive functioning. Future studies should investigate booster sessions to increase durability, optimize training duration, and study different sub-groups of PD patients along the continuum of cognitive decline towards PD dementia.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

Efficacy of Adjuvant Application of Platelet-Rich Plasma After Needle Aspiration of Calcific Deposits for the Treatment of Rotator Cuff Calcific Tendinitis: A Double-Blinded, Randomized Controlled Trial With 2-Year Follow-up

2021 ◽  
Vol 49 (4) ◽  
pp. 873-882
Author(s):  
Bart W. Oudelaar ◽  
Rianne Huis In ‘t Veld ◽  
Edwin M. Ooms ◽  
Relinde Schepers-Bok ◽  
Rob G.H.H. Nelissen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rotator Cuff ◽  
Mixed Model ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Needle Aspiration ◽  
Randomized Controlled ◽  
Clinical Scores ◽  
Calcific Deposits

Background: Needle aspiration of calcific deposits (NACD) is a frequently used treatment for rotator cuff calcific tendinitis (RCCT). However, a substantial number of patients experience recurrent or persisting shoulder symptoms after NACD. Purpose: To compare the effects of adjuvant application of platelet-rich plasma (PRP) after NACD (NACP+PRP) with those of conventional NACD with corticosteroids (NACD+corticosteroids) on pain, shoulder function, and quality of life (QoL). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In a single-center, double-blinded, randomized controlled trial, 80 adults with symptomatic RCCT were randomly allocated to receive NACD+corticosteroids or NACD+PRP. Pain, shoulder function, and QoL were assessed at baseline; 6 weeks; and 3, 6, 12, and 24 months after treatment using a numeric rating scale for pain (NRS); the Constant-Murley score (CMS); the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH); the Oxford Shoulder Score (OSS); and the EuroQol 5-dimension scale (EQ-5D). Additionally, resorption of calcific deposits and the integrity of rotator cuff tendons were assessed by using standard radiographs and ultrasound examination, respectively. The results were analyzed using noninferiority analysis for NRS scores and a mixed model for repeated measures. Results: Eighty patients were included (48 female; mean age, 49 ± 6 years; 41 patients in the NACD+PRP group). Both groups showed improvement of clinical scores at the 2-year follow-up ( P < .001 for all clinical scores). NACD+PRP was found to be noninferior to NACD+corticosteroids with regard to the mean decrease of NRS scores (4.34 vs 3.56; P = .003). Mixed-model analysis showed a significant difference in favor of NACD+PRP (CMS, P < .001; DASH, P = .002; OSS, P = .010; EQ-5D, P < .001). However, clinically relevant differences in favor of NACD+PRP were only seen at the 6-month follow-up for NRS and CMS scores, whereas at the 6-week follow-up a clinically relevant difference in favor of NACD+corticosteroids was found for all clinical scores except for the NRS. Full resorption of calcific deposits was present in 84% of the NACD+PRP group compared with 66% in the NACD+corticosteroids group ( P = .081). In the NACD+PRP group, 10 (24%) patients required a second NACD procedure compared with 19 (49%) patients in the NACD+corticosteroids group ( P = .036). Six complications, of which 5 were frozen shoulders, occurred in the NACD+PRP group compared with 1 complication in the NACD+corticosteroids group ( P = .11). Conclusion: NACD+PRP resulted in worse clinical scores at the 6-week follow-up but better clinical scores at the 6-month follow-up compared with NACD+corticosteroids. At the 1- and 2-year follow-ups, the results were comparable between groups. Furthermore, PRP seemed to reduce the need for additional treatments but was associated with more complications. In conclusion, NACD+corticosteroids had a favorable early effect on pain and function combined with low comorbidity. Thus, it remains the treatment of choice for patients with RCCT. Registration: NCT02173743 (ClinicalTrials.gov identifier).

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals The effects of a physical and cognitive training intervention vs. physical training alone on older adults’ physical activity: A randomized controlled trial with extended follow-up during COVID-19

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258559
Author(s):  
Tiina Savikangas ◽  
Timo Törmäkangas ◽  
Anna Tirkkonen ◽  
Markku Alen ◽  
Roger A. Fielding ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Randomized Controlled Trial ◽  
Executive Functions ◽  
Cognitive Training ◽  
Physical Training ◽  
Controlled Trial ◽  
Pooled Data ◽  
Randomized Controlled

Background Executive functions underlie self-regulation and are thus important for physical activity and adaptation to new situations. The aim was to investigate, if yearlong physical and cognitive training (PTCT) had greater effects on physical activity among older adults than physical training (PT) alone, and if executive functions predicted physical activity at baseline, after six (6m) and twelve months (12m) of the interventions, one-year post-intervention follow-up and an extended follow-up during COVID-19 lockdown. Methods Data from a single-blinded, parallel-group randomized controlled trial (PASSWORD-study, ISRCTN52388040) were utilized. Participants were 70–85 years old community-dwelling men and women from Jyväskylä, Finland. PT (n = 159) included supervised resistance, walking and balance training, home-exercises and self-administered moderate activity. PTCT (n = 155) included PT and cognitive training targeting executive functions on a computer program. Physical activity was assessed with a one-item, seven-scale question. Executive functions were assessed with color-word Stroop, Trail Making Test (TMT) B-A and Letter Fluency. Changes in physical activity were modeled with multinomial logistic models and the impact of executive functions on physical activity with latent change score models. Results No significant group-by-time interaction was observed for physical activity (p>0.1). The subjects were likely to select an activity category higher than baseline throughout the study (pooled data: B = 0.720–1.614, p<0.001–0.046). Higher baseline Stroop predicted higher physical activity through all subsequent time-points (pooled data: B = 0.011–0.013, p = 0.015–0.030). Higher baseline TMT B–A predicted higher physical activity at 6m (pooled data: B = 0.007, p = 0.006) and during COVID-19 (B = 0.005, p = 0.030). In the PT group, higher baseline Letter Fluency predicted higher physical activity at 12m (B = -0.028, p = 0.030) and follow-up (B = -0.042, p = 0.002). Conclusions Cognitive training did not have additive effects over physical training alone on physical activity, but multicomponent training and higher executive function at baseline may support adaptation to and maintenance of a physically active lifestyle among older adults.

scholarly journals Can transcranial direct current stimulation enhance outcomes from cognitive training? A randomized controlled trial in healthy participants

2013 ◽  
Vol 16 (9) ◽  
pp. 1927-1936 ◽  
Author(s):  
Donel M. Martin ◽  
Rose Liu ◽  
Angelo Alonzo ◽  
Melissa Green ◽  
Michael J. Player ◽  
...  
Keyword(s):  
Working Memory ◽  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Direct Current Stimulation ◽  
Randomized Controlled ◽  
Healthy Participants

Abstract Computer-administered cognitive training (CT) tasks are a common component of cognitive remediation treatments. There is growing evidence that transcranial direct current stimulation (tDCS), when given during cognitive tasks, improves performance. This randomized, controlled trial explored the potential synergistic effects of CT combined with tDCS in healthy participants. Altogether, 60 healthy participants were randomized to receive either active or sham tDCS administered during training on an adaptive CT task (dual n-back task), or tDCS alone, over 10 daily sessions. Cognitive testing (working memory, processing speed, executive function, reaction time) was conducted at baseline, end of the 10 sessions, and at 4-wk follow-up to examine potential transfer effects to non-trained tasks. Altogether, 54 participants completed the study. Over the 10 ‘online’ sessions, participants in the active tDCS+CT condition performed more accurately on the CT task than participants who received sham tDCS+CT. The performance enhancing effect, however, was present only during tDCS and did not result in greater learning (i.e. improvement over sessions) on the CT task. These results confirm prior reports of enhancement of cognitive function during tDCS stimulation. At follow-up, the active tDCS+CT group, but not the sham tDCS+CT group, showed greater gains on a non-trained test of attention and working memory than the tDCS-only group (p < 0.01). Although this gain can mainly be attributable to training, this result suggests that active tDCS may have a role in further enhancing outcomes.

Rotator Cuff Calcific Tendinitis: Ultrasound-Guided Needling and Lavage Versus Subacromial Corticosteroids: Five-Year Outcomes of a Randomized Controlled Trial

2017 ◽  
Vol 45 (14) ◽  
pp. 3305-3314 ◽  
Author(s):  
Pieter Bas de Witte ◽  
Arjen Kolk ◽  
Ferdinand Overes ◽  
Rob G.H.H. Nelissen ◽  
Monique Reijnierse
Keyword(s):  
Randomized Controlled Trial ◽  
Rotator Cuff ◽  
Repeated Measures ◽  
Mixed Model ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Background: Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. Purpose: To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)–guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Results: Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 ( P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 ( P = .32). There was total resorption in 62% of group 1 and 73% of group 2 ( P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, –8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of follow-up. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period ( P < .001). Conclusion: No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry).

scholarly journals Changing Stress Mindsets with a Novel Imagery Intervention: A Randomized Controlled Trial

2019 ◽  
Author(s):  
Jacob J Keech ◽  
Martin S Hagger ◽  
Kyra Hamilton
Keyword(s):  
Randomized Controlled Trial ◽  
Academic Performance ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Future Research ◽  
Ecological Stress ◽  
Beneficial Effects ◽  
Randomized Controlled

Objective: Changing individuals’ stress mindset has emerged as a technique that may be effective in aiding stress management, but there is limited data on the effects of this technique in managing stress in ‘real world’ contexts beyond a few days. This study aimed to (1) evaluate the efficacy of a novel imagery-based intervention in changing stress mindset; and, (2) evaluate the effect of the intervention on stress-related outcomes, compared to a control, after two weeks. Methods: The study adopted a pre-registered randomized controlled trial design. University students (N = 150) attended a research laboratory twice over two weeks, receiving the intervention or control condition stimuli in Session 1, and completing measures in both sessions. Academic performance data was collected from university records. Results: Mixed model ANOVAs revealed a large-sized difference in stress mindset among intervention group participants immediately following the intervention and at the follow-up relative to controls. There were also robust effects of the intervention on perceived distress, positive and negative affect, proactive behavior, and academic performance at the follow-up in individuals with high baseline perceived distress. Conclusions: Findings indicate that the intervention is a promising approach for changing individuals’ stress mindset and that changing stress mindset can have beneficial effects on coping with ecological stressors. Future research should use intensive longitudinal designs to examine momentary activation of stress mindset and responses to ecological stress.

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