scholarly journals The added value of cognition-targeted exercise versus symptom-targeted exercise for multiple sclerosis fatigue: A randomized controlled pilot trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0258752
Author(s):  
Azza Alketbi ◽  
Salah Basit ◽  
Nouran Hamza ◽  
Lori M. Walton ◽  
Ibrahim M. Moustafa
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Outcome ◽  
Outcome Measures ◽  
Recruitment Rate ◽  
Control Group ◽  
Entire Study ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Intervention Protocol

Background Fatigue is considered one of the most common symptoms of multiple sclerosis (MS) and lacks a current standardized treatment. Therefore, the aim of this study was to examine the feasibility and effectiveness of a cognition-targeted exercise versus symptom-targeted exercise for MS fatigue. Methods In this Pilot, parallel-group, randomized controlled trial, sixty participants with multiple sclerosis, were randomly assigned to either a Cognition-Targeted Exercise (CTE) (N = 30, mean age 41) or a Symptom-Targeted Exercise (STE) (N = 30, mean age 42). The participants in the experimental group received eight, 50-minute sessions of weekly Cognitive Behavior Therapy (CBT) in addition to a CTE Program; whereas, participants in the control group received eight, 50-minute sessions of weekly CBT in addition to the standardized physiotherapy program (STE Program). Feasibility was assessed through recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS). All outcome measures were assessed at baseline (pretreatment), following completion of the eight visit intervention protocol, and at 3-months follow-up. Results The recruitment rate was 60% and 93% of participants completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded. A Generalized Estimation Equation Model revealed a significant difference over time as an interaction term during the post and follow up visit for all clinical outcome measures (p < .001). Conclusion The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE). Feasibility and efficacy data from this pilot study provide support for a full-scale RCT of CTE as an integral component of Multiple Sclerosis fatigue management.

scholarly journals Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6645
Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cardiac Rehabilitation ◽  
Exercise Testing ◽  
Text Messages ◽  
Control Group ◽  
Stand Test ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

scholarly journals Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-11 ◽  
Author(s):  
Caroline A. Smith ◽  
Caroline A. Crowther ◽  
Oswald Petrucco ◽  
Justin Beilby ◽  
Hannah Dent
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Effect ◽  
Controlled Trial ◽  
Acupuncture Group ◽  
Control Group ◽  
Primary Dysmenorrhea ◽  
Menstrual Pain ◽  
Randomized Controlled ◽  
Significant Difference

We examined the effectiveness of acupuncture to reduce the severity and intensity of primary dysmenorrhea. A randomized controlled trial compared acupuncture with control acupuncture using a placebo needle. Eligible women were aged 14–25 years with a diagnosis of primary dysmenorrhea. Women received nine sessions of the study treatment over 3 months. The primary outcomes were menstrual pain intensity and duration, overall improvement in dysmenorrhea symptoms and reduced need for additional analgesia, measured at 3, 6 and 12 months from trial entry. A total of 92 women were randomly assigned to the intervention (acupuncture and control ). At 3 months although pain outcomes were lower for women in the acupuncture group compared with the control group, there was no significant difference between groups. Women receiving acupuncture reported a small reduction in mood changes compared with the control group, relative risk (RR) 0.72, 95% confidence interval (CI) 0.53–1.00, . Follow-up at 6 months found a significant reduction in the duration of menstrual pain in the acupuncture group compared with the control group, mean difference –9.6, 95% CI –18.9 to –0.3, , and the need for additional analgesia was significantly lower in the acupuncture group compared with the control group, RR 0.69, 95% CI 0.49–0.96, , but the follow-up at 12 months found lack of treatment effect. To conclude, although acupuncture improved menstrual mood symptoms in women with primary dysmenorrhea during the treatment phase, the trend in the improvement of symptoms during the active phase of treatment, and at 6 and 12 months was non-significant, indicating that a small treatment effect from acupuncture on dysmenorrhea may exist. In the study, acupuncture was acceptable and safe, but further appropriately powered trials are needed before recommendations for clinical practice can be made.

scholarly journals Effectiveness of Low-Frequency Stimulation in Proprioceptive Neuromuscular Facilitation Techniques for Post-Ankle-Sprain Balance and Proprioception in Adults- a Randomized controlled trial

2020 ◽  
Author(s):  
KHALID A ALAHMARI ◽  
Paul Silvian Samuel ◽  
Irshad Ahmad ◽  
Ravi Shankar Reddy ◽  
Jaya Shanker Tedla ◽  
...  
Keyword(s):  
Physical Activity ◽  
Range Of Motion ◽  
Outcome Measures ◽  
Ankle Sprain ◽  
Low Frequency ◽  
Control Group ◽  
Significant Difference ◽  
Proprioceptive Neuromuscular Facilitation ◽  
Experimental Group

Abstract BackgroundStretching is an important part of post-ankle-sprain rehabilitation, as well as an effective exercise for improving general ankle-joint performance. But the combination of stretching alongside muscle stimulation has not yet been extensively studied. Therefore the purpose of the present research is to compare the baseline, post- and follow-up effects of the proprioceptive neuromuscular facilitation (PNF) stretching technique combined with transcutaneous electrical nerve stimulation (TENS), as compared against the effects of the PNF stretching technique alone.MethodsSixty subjects with lateral ankle sprains were selected and randomly allocated to three groups: Experimental Group One (EG 1), Experimental Group Two (EG 2), and the Control Group (CG). Subjects in EG 1 received the PNF stretching technique combined with TENS. Subjects in EG2 received the PNF stretching technique alone. Both experimental groups received these treatments for 4 weeks (4 days/week); follow-up assessments were administered in the third and fifth weeks. CG received no treatment; outcome measures alone were assessed. Outcome measures comprised pain, flexibility, proprioception, range of motion, muscle strength, physical activity, and balance. A mixed-model ANOVA was used to analyze the effects of time factors and groups on these outcome measures.ResultsThere was significant interaction (time and group), and the time effect for all the outcome measures (p < 0.05). Physical activity, dorsiflexion, and balance in the medial, lateral, anterolateral, and anteromedial directions did not show a significant difference between the groups. EG 1 showed significant improvement for all the outcome variables between pre- and post-treatment and follow-up when compared to the other groups.ConclusionsThe present study showed that a 12-session treatment program of 3 weeks’ duration that combines PNF stretching with low-frequency TENS for post-ankle sprain subjects, compared against PNF stretching alone, produced significant improvements in balance, proprioception, strength, and range of motion. The study also showed that the treatment effect was sustained even after treatment was ceased after the follow-up assessment in the fifth week.Trial Registration:Human Research Ethics Committee approval for the trial (approval no.: (ECM#2019-26)Clinical trial was also registered in the Clinical Trials Registry – ISRCTN 18013941

scholarly journals Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

scholarly journals A Pilot Randomized Controlled Trial of Dialectical Behavior Therapy (DBT) for Craving and Cessation in Marijuana Use Disorder Patients: Feasibility, Acceptability, and Appropriateness

2020 ◽  
Author(s):  
Mohammadreza davoudi ◽  
Zahra allame ◽  
Aliakbar Foroughi ◽  
Amir Abbas taheri
Keyword(s):  
Dialectical Behavior Therapy ◽  
Controlled Trial ◽  
Marijuana Use ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pilot Rct ◽  
Pilot Randomized Controlled Trial

Abstract Purpose: This study has investigated the feasibility and preliminary efficacy of DBT for Marijuana cessation and craving reduction as a pilot RCT.Methods: Sixty-one participants were randomly assigned to one of the DBT or psycho-education as active control-group with two-month follow-up. Patients completed measures at pre-interventions, post-interventions, and a two-month follow-up.Results: feasibility in DBT is significantly higher than the control group. In the DBT group 29/30 (96% retention) and in control group 24/31 (77% retention) completed all sessions (χ2= 4.95, p = 0.02). Moreover, 29/30 (96%) in the DBT group and 20/31 (64.5%) in the control group completed the two-month follow-up (χ2= 9.97, p = 0.002). For the acceptability of the intervention, results showed 16.57 (agree) in DBT and 9.6 (neither agree nor disagree) in control groups for p < 0.05. For appropriateness, results showed 17.03 (completely agree) in DBT and 10.7 (neither agree nor disagree) in control-groups for p < 0.05. for craving, results confirmed that there is no significant difference between groups (F = 3.52, p > 0.05); however, in “emotionality,” subscale DBT showed a significant reduction rather than the control group (F = 19.94, p < 0.05). For cessation rates, DBT was compared with the control group at the posttest (46% vs. 16%) and follow-up (40% vs. 9.5%), and results proved higher effectiveness in the DBT group for p < 0.05. Furthermore, among those who have lapsed, participation in the DBT group had fewer days than consume for p <0.05.Conclusions: DBT shows feasibility, acceptability, and promise in improving cessation rate in Marijuana use disorder and warrants further investigations.

scholarly journals Effects of virtual reality associated with serious games for upper limb rehabilitation in patients with multiple sclerosis. A randomized controlled trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance. Trial registration: This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908, Nov 2019.

scholarly journals Effects of a novel dye containing toothpaste versus regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis: A Randomized Controlled Trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Avita Rath ◽  
Chong Junning ◽  
Priyadarshini HR ◽  
Brandon Nicholas Teo ◽  
Naik Hsian Zhen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Image Analysis ◽  
Controlled Trial ◽  
Control Group ◽  
Dental Biofilm ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Tooth Surfaces ◽  
The Mean

AIM:To compare the effects of a plaque disclosing toothpaste with a regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis.MATERIALS AND METHODS:This study was a randomized controlled trial with a parallel design. Forty patients, both males and females aged 18-25 years with chronic generalized gingivitis (N=40) were randomly allocated to two groups of twenty each (n=20), using lottery method. Participants in the experimental group brushed with a plaque disclosing toothpaste, while participants in the control group brushed with regular fluoridated toothpaste. Clinically, biofilm was measured using Silness & Loe Plaque Index, both at baseline and at follow up visits by two assessors who were blinded to group allocation. Adjunctly, intraoral photographs were taken for Digital Plaque Image Analysis of the remaining dental biofilm in the upper and lower anterior labial tooth surfaces, and calculated based on the area of stained pixels. Data was analyzed using SPSS version 22. Mean plaque scores between the groups were compared using independent sample t-test and p<0.05 was considered significant.RESULTS:Data of all the 40 participants were analyzed as they were no drop outs. No significant differences were found in the mean plaque scores between the two groups (p=0.059) at the end of the study. Similarly, Digital Plaque Image Analysis showed no significant difference in the mean plaque scores between the groups (p= 0.93).CONCLUSION:This study showed that there are no additional benefits of using a plaque disclosing toothpaste, in enhancing the removal of the supragingival dental biofilm during routine oral hygiene maintenance.   

scholarly journals Dissemination and Effectiveness of the Peer Marketing and Messaging of a Web-Assisted Tobacco Intervention: Protocol for a Hybrid Effectiveness Trial (Preprint)

2019 ◽  
Author(s):  
Jamie M Faro ◽  
Elizabeth A Orvek ◽  
Amanda C Blok ◽  
Catherine S Nagawa ◽  
Annalise J McDonald ◽  
...  
Keyword(s):  
Health Communication ◽  
Risk Reduction ◽  
Recommender System ◽  
Recruitment Rate ◽  
Control Group ◽  
Patient Centered ◽  
Intervention Protocol ◽  
Patient Reported ◽  
The Impact

BACKGROUND Smoking continues to be the leading preventable cause of death. Digital Interventions for Smoking Cessation (DISCs) are health communication programs accessible via the internet and smartphones and allow for greater reach and effectiveness of tobacco cessation programs. DISCs have led to increased 6-month cessation rates while also reaching vulnerable populations. Despite this, the impact of DISCs has been limited and new ways to increase access and effectiveness are needed. OBJECTIVE We are conducting a hybrid effectiveness-dissemination study. We aim to evaluate the effectiveness of a machine learning–based approach (recommender system) for computer-tailored health communication (CTHC) over a standard CTHC system based on quit rates and risk reduction. In addition, this study will assess the dissemination of providing access to a peer recruitment toolset on recruitment rate and variability of the sample. METHODS The Smoker-to-Smoker (S2S) study is a 6-month hybrid effectiveness dissemination trial conducted nationally among English-speaking, current smokers aged ≥18 years. All eligible participants will register for the DISC (Decide2quit) and be randomized to the recommender system CTHC or the standard CTHC, followed by allocation to a peer recruitment toolset group or control group. Primary outcomes will be 7-day point prevalence and risk reduction at the 6-month follow-up. Secondary outcomes include recruitment rate, website engagement, and patient-reported outcomes collected via the 6-month follow-up questionnaire. All primary analyses will be conducted on an intent-to-treat basis. RESULTS The project is funded from 2017 to 2020 by the Patient Centered Outcomes Research Institute. Enrollment was completed in early 2019, and 6-month follow-ups will be completed by late 2019. Preliminary data analysis is currently underway. CONCLUSIONS Conducting a hybrid study with both effectiveness and dissemination hypotheses raises some unique challenges in the study design and analysis. Our study addresses these challenges to test new innovations and increase the effectiveness and reach of DISCs. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/14814

scholarly journals Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

Enhancing adoptive parenting: A randomized controlled trial

2010 ◽  
Vol 15 (4) ◽  
pp. 529-542 ◽  
Author(s):  
Alan Rushton ◽  
Elizabeth Monck ◽  
Morven Leese ◽  
Paul McCrone ◽  
Jessica Sharac
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Adoptive Parents ◽  
Control Group ◽  
Parenting Interventions ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Significant Difference

The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a “services as usual” group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference ( p < 0.007) was found for “satisfaction with parenting” in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters’ satisfaction with parenting in the intervention group compared to the routine service group.

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