Free From Falls education and exercise program for reducing falls in people with multiple sclerosis: A randomized controlled trial

2021 ◽  
pp. 135245852110468
Author(s):  
Michelle H Cameron ◽  
Andrea Hildebrand ◽  
Cinda L Hugos ◽  
Grace I Judd ◽  
Garnett McMillan ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Credible Intervals ◽  
Falls In Older Adults ◽  
The Impact

Background: People with multiple sclerosis (PwMS) fall frequently. Community-delivered exercise and education reduce falls in older adults, but their efficacy in multiple sclerosis (MS) is unknown. Objectives: To evaluate the impact of the Free From Falls (FFF) group education and exercise program on falls in PwMS. Methods: This was a prospective, assessor-blinded, two-arm parallel randomized controlled trial. Ninety-six participants were randomized to FFF (eight weekly 2 hour sessions) or the control condition (a fall prevention brochure and informing their neurologist of their fall history). Participants counted falls prospectively from enrollment through 6 months following intervention. Effects on fall frequency were evaluated by the Bayesian analysis. Results: The modeled mean fall frequency pre-intervention was 1.2 falls/month in the FFF group (95% credible intervals (CIs) = 0.8–2.0) and 1.4 falls/month in the control group (95% CI = 0.9–2.1). Fall frequency decreased by 0.6 falls/month in both groups over time (nadir 4–6 months post-intervention: FFF 0.6 falls/month (95% CI = 0.4–0.9); control 0.8 falls/month (95% CI = 0.5–1.1)). Conclusion: In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.

scholarly journals Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Adelaida María Castro-Sánchez ◽  
Guillermo A. Matarán-Peñarrocha ◽  
Inmaculada Lara-Palomo ◽  
Manuel Saavedra-Hernández ◽  
Manuel Arroyo-Morales ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Exercise Program ◽  
Aquatic Exercise ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Therapy Room ◽  
Experimental Group

Background. Multiple sclerosis (MS) is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients.Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients.Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-week treatment program. The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relaxation exercises in therapy room. Outcome variables were pain, disability, spasm, depression, fatigue, and autonomy, which were assessed before the intervention and immediately and at 4 and 10 weeks after the last treatment session.Results. The experimental group showed a significant (P<0.028) and clinically relevant decrease in pain intensityversusbaseline, with an immediate posttreatment reduction in median visual analogue scale scores of 50% that was maintained for up to 10 weeks. Significant improvements were also observed in spasm, fatigue, disability, and autonomy.Conclusion. According to these findings, an Ai-Chi aquatic exercise program improves pain, spasms, disability, fatigue, depression, and autonomy in MS patients.

scholarly journals The Impact of Shorter, More Frequent Outdoor Play Periods on Preschoolers’ Physical Activity during Childcare: A Cluster Randomized Controlled Trial

2019 ◽  
Vol 16 (21) ◽  
pp. 4126 ◽  
Author(s):  
Molly Driediger ◽  
Stephanie Truelove ◽  
Andrew M. Johnson ◽  
Leigh M. Vanderloo ◽  
Brian W. Timmons ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Outdoor Play ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Children’s physical activity levels are higher at the start of outdoor playtime, which suggests that shorter, more frequent play periods might result in greater amounts of daily physical activity. In this extension of the Supporting Physical Activity in the Childcare Environment (SPACE) cluster randomized controlled trial, we explored the impact of four 30-min daily outdoor unstructured play periods on preschoolers’ moderate-to-vigorous-intensity physical activity (MVPA). Experimental childcare centres (n = 6) implemented four 30-min daily outdoor playtimes for 8 weeks, while control centres (n = 6) maintained their two 60-min outdoor sessions. Actical™ accelerometers were used to measure preschoolers’ physical activity pre- and post-intervention for 5 days during childcare hours. Linear mixed effects models were used to determine the impact of the intervention on preschoolers’ MVPA. Of the 185 preschoolers enrolled (54.20% female; mean age = 39.90 months, SD = 7.24), 127 (65 experimental and 62 control) were included in the analysis (30% and 9% loss to follow-up for experimental and control group preschoolers, respectively). No significant differences in MVPA were observed between groups over time (p = 0.36). Preschoolers’ MVPA did not improve after the introduction of shorter outdoor play periods. The loss of data due to wear time noncompliance and participant attrition may have influenced these findings. Trial registration: ISRCTN70604107 (October 8, 2014).

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.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

Early Physical Therapy Effects on the High-Risk Infant: A Randomized Controlled Trial

PEDIATRICS ◽  
1986 ◽  
Vol 78 (2) ◽  
pp. 216-224
Author(s):  
Martha C. Piper ◽  
V. Ildiko Kunos ◽  
Diana M. Willis ◽  
Barbara L. Mazer ◽  
Maria Ramsay ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
High Risk ◽  
Motor Development ◽  
Controlled Trial ◽  
Physical Growth ◽  
Control Group ◽  
Randomized Controlled ◽  
Early Physical Therapy ◽  
The Impact

A prospective, randomized, controlled trial was conducted to assess the effects of early physical therapy on infants at risk for neurologic sequelae and to evaluate the impact of such early treatment on the prevention or minimization of future handicaps. A cohort of 134 infants who had received care in two Montreal inborn neonatal intensive care units was identified prospectively. Infants were stratified according to prognosis and birth weight and were randomly assigned to either an experimental or control group. Babies assigned to the experimental group received early physical therapy, whereas those allocated to the control group received conventional follow-up care. Outcome measures were administered by independent evaluators at 12 months and included measures of neurologic status, motor and overall development, and physical growth. No statistically significant differences on any of the measured outcomes at 12 months were found between the experimental and control groups. Infants weighing less than 750 g at birth, regardless of group assignment, consistently demonstrated significant delays in their growth and development when compared with their heavier peers. The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.

Effect of n-3 long-chain polyunsaturated fatty acids supplementation in healthy mothers on DHA and EPA profiles in maternal and umbilical blood: a randomized controlled trial

2019 ◽  
Vol 47 (2) ◽  
pp. 200-206
Author(s):  
Dragan Soldo ◽  
Matija Mikulić-Kajić ◽  
Lara Spalldi Barišić ◽  
Nikolina Penava ◽  
Martina Orlović ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Randomized Controlled Trial ◽  
Corn Oil ◽  
Controlled Trial ◽  
Lipid Extraction ◽  
Control Group ◽  
Randomized Controlled ◽  
Umbilical Blood ◽  
Epa And Dha ◽  
The Impact

AbstractBackgroundThe objective of the study was to compare the effect of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) dietary supplementation on their concentration in total lipids (TL) and lipid fractions of maternal and umbilical vein (UV) blood. The specific objective was to analyze the impact of EPA and DHA supplementation on pregnancy outcome and neonatal birth weight.MethodsWomen were randomly single-blinded (randomized controlled trial; ISRCTN36705743) allocated to the group receiving EPA and DHA supplementation (supplemented group) or the group receiving placebo-corn oil (control group) in the time period from January 1st, 2016 until March 1st, 2017. Women in the supplemented group (n=45) took 360 mg EPA and 240 mg DHA daily while controls (n=42) were given a placebo. Maternal and UV bloods were obtained at delivery. After lipid extraction, phospholipids (PL), cholesterol esters (CE), triacylglycerols (TG) and non-esterified fatty acids were separated by thin layer chromatography and analyzed by gas chromatography.ResultsHigher DHA concentrations in TL (37.24±21.87 mg/L), PL (13.14±8.07 mg/L) and triacylglycerols (2.24±2.21 mg/L) were recorded in mothers from the supplemented group when compared to the study group (TL 21.89±14.53 mg/L; P<0.001; PL 9.33±5.70 mg/L; P=0.013; TG 0.56±0.43 mg/L; P<0.001). Higher DHA concentrations in UV samples were found in TL (11.51±7.34 mg/L), PL (5.29±3.31 mg/L) and triacylglycerols (0.62±0.46 mg/L) from the supplemented groups compared with controls (TL 7.37±3.60 mg/L; P=0.002; PL 3.52±2.19 mg/L; P=0.005; TG 0.40±0.46 mg/L; P=0.035). The ratio of AA:DHA was lower in maternal (2.43) and UV serum (4.0) of the supplemented group than in the control group (maternal 3.85 P<0.001; UV 4.91 P<0.001).ConclusionThe study demonstrated the higher ratio of AA/DHA in the control group indicating that pregnant women on the traditional Herzegovina diet need supplementation with DHA and EPA.

scholarly journals Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

2021 ◽  
Author(s):  
Remi Yoshikata ◽  
Khin Zay Yar Myint ◽  
Hiroaki Ohta ◽  
Yoko Ishigaki
Keyword(s):  
Randomized Controlled Trial ◽  
Visceral Fat ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Climacteric Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic some family physicians were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psycho-social support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received &lsquo;care as usual&rsquo;. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW in-terventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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