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Dalfampridine to Improve Balance in Multiple Sclerosis: Substudy from a Randomized Placebo-Controlled Trial.
Prosperini, L, Castelli, L, De Giglio, L, Bonanno, V, Gasperini, C, Pozzilli, C
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics. 2020;(2):704-709
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Abstract
This was a substudy of a randomized, double-blind, placebo-controlled trial originally designed to explore the effect of dalfampridine on information processing speed (2013-002558-64 EU Clinical Trials Register) in patients with multiple sclerosis (MS). A total of 120 patients were originally randomized in a 2:1 ratio to receive dalfampridine 10 mg or placebo twice daily for 12 weeks. Here, we sought to explore the effect of dalfampridine on static balance in single-task and dual-task conditions in a subgroup of 41 patients. They underwent static posturography in quiet standing (single-task) and while performing the Stroop test (dual-task) at randomization (baseline), after 12 weeks and after a 4-week wash-out period. Baseline characteristics of active group (n = 27) did not differ from those of placebo group (n = 14). Dalfampridine treatment was associated with better balance control than placebo in both single-task (F = 4.80, p = 0.034) and dual-task (F = 6.42, p = 0.015) conditions, with small-to-moderate effect sizes (Cohen's f2 = 0.122-0.162). The beneficial effect of dalfampridine was not retained 4 weeks after its discontinuation. The rate of accidental falls per month did not differ between the two groups (p = 0.12). Our preliminary findings suggest that dalfampridine can be considered a potential option to treat balance impairment due to MS. Larger sample sizes are needed to verify if the beneficial effect of dalfampridine on balance can be translated into a reduced risk of accidental falls.
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Vitamin D Supplementation Improves the Effects of the Rehabilitation Program on Balance and Pressure Distribution in Patients after Anterior Cervical Interbody Fusion-Randomized Control Trial.
Skrobot, W, Perzanowska, E, Krasowska, K, Flis, DJ, Dzik, KP, Kloc, W, Kaczor, JJ, Antosiewicz, J
Nutrients. 2020;(12)
Abstract
STUDY DESIGN A double-blinded, randomized controlled trial. BACKGROUND Surgery is effective in reducing pain intensity in patients with cervical disc disease. However, functional measurements demonstrated that the results have been not satisfactory enough. Thus, rehabilitation programs combined with the supplementation of vitamin D could play an essential role. METHODS The study recruited 30 patients, aged 20 to 70 years, selected for anterior cervical interbody fusion (ACIF). The patients were randomly divided into the placebo (Pl) and vitamin D (3200 IU D3/day) supplemented groups. The functional tests limits of stability (LOS), risk of falls (RFT), postural stability (PST), Romberg test, and foot pressure distribution were performed before supplementation (BS-week 0), five weeks after supplementation (AS-week 5), four weeks after surgery (BSVR-week 9), and 10 weeks after supervising rehabilitation (ASVR-week 19). RESULTS The concentration of 25(OH)D3 in the serum, after five weeks of supplementation, was significantly increased, while the Pl group maintained the same. The RFT was significantly reduced after five weeks of vitamin D supplementation. Moreover, a further significant decrease was observed following rehabilitation. In the Pl group, no changes in the RFT were observed. The overall postural stability index (OSI), LOS, and the outcomes of the Romberg test significantly improved in both groups; however, the effects on the OSI were more pronounced in the D3 group at the end of the rehabilitation program. CONCLUSIONS Our data suggest that vitamin D supplementation positively affected the rehabilitation program in patients implemented four weeks after ACIF by reducing the risk of falls and improving postural stability.
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Postural Balance Effects Associated with 400, 4000 or 10,000 IU Vitamin D3 Daily for Three Years: A Secondary Analysis of a Randomized Clinical Trial.
Burt, LA, Gabel, L, Billington, EO, Hanley, DA, Boyd, SK
Nutrients. 2020;(2)
Abstract
Vitamin D supplementation is proposed as a fall prevention strategy, as it may improve neuromuscular function. We examined whether three years of vitamin D supplementation (400, 4000 or 10,000 IU daily) affects postural sway in older adults. Three hundred and seventy-three non-osteoporotic, vitamin D-sufficient, community-dwelling healthy adults, aged 55-70 years, were randomized to 400 (n = 124), 4000 (n = 125) or 10,000 (n = 124) IU daily vitamin D3 for three years. Sway index was assessed at baseline, 12-, 24- and 36-months using the Biosway machine. We tested participants under four conditions: eyes open or eyes closed with firm (EOFI, ECFI) or foam (EOFO, ECFO) surfaces. Secondary assessments examined sway in the anterior-posterior (AP) and medio-lateral (ML) directions. Linear mixed effects models compared sway between supplementation groups across time. Postural sway under EOFO and ECFO conditions significantly improved in all supplementation groups over time. Postural sway did not differ between supplementation groups at any time under any testing conditions in normal, AP or ML directions (p > 0.05 for all). Our findings suggest that high dose (4000 or 10,000 IU) vitamin D supplementation neither benefit nor impair balance compared with 400 IU daily in non-osteoporotic, vitamin D-sufficient, healthy older adults.
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High and odd impact exercise training improved physical function and fall risk factors in community-dwelling older men.
Allison, SJ, Brooke-Wavell, K, Folland, J
Journal of musculoskeletal & neuronal interactions. 2018;(1):100-107
Abstract
UNLABELLED High impact exercise programmes can improve bone strength, but little is known about whether this type of training further benefits fracture risk by improving physical function in older people. OBJECTIVES This study investigated the influence of high impact exercise on balance, muscle function and morphology in older men. METHODS Fifty, healthy men (65-80 years) were assigned to a 6-month multidirectional hopping programme (TG) and twenty age and physical activity matched volunteers served as controls (CG). Before and after training, muscle function (hop performance, leg press and plantar- and dorsiflexion strength) and physiological determinants (muscle thickness and architecture) as well as balance control (sway path, one leg stance duration) were measured. Resting gastrocnemius medialis (GM) muscle thickness and architecture were assessed using ultrasonography. RESULTS Significant improvements in hop impulse (+12%), isometric leg-press strength (+4%) and ankle plantarflexion strength (+11%), dorsiflexor strength (+20%) were found in the TG compared to the CG (ANOVA interaction, P⟨0.05) and unilateral stance time improved over time for TG. GM muscle thickness indicated modest hypertrophy (+4%), but muscle architecture was unchanged. CONCLUSION The positive changes in strength and balance after high impact and odd impact training would be expected to improve physical function in older adults.
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The Effect of Nordic Walking Training Combined with Vitamin D Supplementation on Postural Control and Muscle Strength in Elderly People-A Randomized Controlled Trial.
Mieszkowski, J, Niespodziński, B, Kochanowicz, A, Gmiat, A, Prusik, K, Prusik, K, Kortas, J, Ziemann, E, Antosiewicz, J
International journal of environmental research and public health. 2018;(9)
Abstract
Nordic Walking (NW) and Vitamin D concentration (Vit D) alone have been shown to contribute to the health and performance of elderly people. However, the interaction between these two factors has yet to be explored. In this study 42 women over 60 years of age (69.02 ± 5.56 years) were recruited and divided in two NW groups: a high-intensity interval training group (HI-NW) and a moderate-intensity continuous training group (MI-NW). Individuals from each group completed a 12-week NW training program (3 times a week/2 hours) combined with randomized Vitamin D supplementation (HD = high dose: 4000 IU/day or LD = low dose: 800 IU/day). Body composition, postural control, muscle strength and Vitamin D serum concentration were measured twice; before and after the intervention. To investigate the interaction between supplementation and training a mixed-design analysis of variance (ANOVA) was performed. The HI-NW group, regardless of supplementation dose, increased their Vit D and elbow torque performance. On the other hand, in the MI-NW group the same Vit D outcome was seen only with HD supplementation and was also associated with increased leg muscle mass. In conclusion, beneficial effects of both HI-NW and MI-NW training regimes were seen. The impact of the dose supplementation on Vit D and body composition was related to the type of NW training.
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One session of high-intensity interval training (HIIT) every 5 days, improves muscle power but not static balance in lifelong sedentary ageing men: A randomized controlled trial.
Sculthorpe, NF, Herbert, P, Grace, F
Medicine. 2017;(6):e6040
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Abstract
BACKGROUND Declining muscle power during advancing age predicts falls and loss of independence. High-intensity interval training (HIIT) may improve muscle power, but remains largely unstudied in ageing participants. METHODS This randomized controlled trial (RCT) investigated the efficacy of a low-frequency HIIT (LfHIIT) intervention on peak muscle power (peak power output [PPO]), body composition, and balance in lifelong sedentary but otherwise healthy males. METHODS Thirty-three lifelong sedentary ageing men were randomly assigned to either intervention (INT; n = 22, age 62.3 ± 4.1 years) or control (n = 11, age 61.6 ± 5.0 years) who were both assessed at 3 distinct measurement points (phase A), after 6 weeks of conditioning exercise (phase B), and after 6 weeks of HIIT once every 5 days in INT (phase C), where control remained inactive throughout the study. RESULTS Static balance remained unaffected, and both absolute and relative PPO were not different between groups at phases A or B, but increased significantly in INT after LfHIIT (P < 0.01). Lean body mass displayed a significant interaction (P < 0.01) due to an increase in INT between phases B and C (P < 0.05). CONCLUSIONS 6 weeks of LfHIIT exercise feasible and effective method to induce clinically relevant improvements in absolute and relative PPO, but does not improve static balance in sedentary ageing men.
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Glucose metabolism disorders and vestibular manifestations: evaluation through computerized dynamic posturography.
Bittar, RS, Santos, MD, Mezzalira, R
Brazilian journal of otorhinolaryngology. 2016;(4):372-6
Abstract
INTRODUCTION Global sugar consumption has increased in the past 50 years; its abusive intake is responsible for peripheral insulin resistance, which causes the metabolic syndrome - obesity, diabetes mellitus, hypertension, and coronary heart disease. OBJECTIVE To evaluate the effect of a fractionated diet without glucose as treatment for labyrinthine disorders associated with glucose-insulin index. METHODS The study design was a prospective randomized controlled trial. Fifty-one patients were divided into two groups: the diet group (DG), which comprised subjects treated with a fractionated diet with glucose restriction, and the control group (CG), in which individuals were not counseled regarding diet. Patients underwent computerized dynamic posturography (CDP) and visual analog scale (VAS) on the first and 30th days of the study. RESULTS There was improvement in the assessed posturographic conditions and VAS self-assessment in the DG group after 30 days when compared to the control group. CONCLUSION The fractionated diet with glucose restriction was effective for the treatment of vestibular dysfunction associated with glucose metabolism disorders.
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Pharmacodynamic interactions of a solid formulation of sodium oxybate and ethanol in healthy volunteers.
Pross, N, Patat, A, Vivet, P, Bidaut, M, Fauchoux, N
British journal of clinical pharmacology. 2015;(3):480-92
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AIM: The pharmacologic effects of sodium oxybate (SO) have a number of similarities with those of alcohol. This study evaluated the pharmacodynamic interaction of SMO.IR (a solid immediate release formulation of SO) and alcohol (0.7 (males) or 0.57 (females) g kg(-1) alcohol using 40% vodka). METHODS In a randomized, double-blind, double-dummy, crossover trial, 24 healthy volunteers received randomly a) 2.25 g SMO.IR and placebo alcohol preparation, b) 2.25 g f SMO.IR and alcohol, c) 2.25 g SMO.IR matching placebo and alcohol and d) 2.25 g of SMO.IR matching placebo and placebo alcohol preparation. Objective and subjective cognitive parameters, adverse events and vital signs were assessed before, 15 and 165 min after treatment administration. RESULTS Alcohol produced the expected cognitive impairment and the expected subjective sedation rapidly after intake (from 15 min). The objective effects of SMO.IR were much less pronounced than those of alcohol. The reverse was observed for subjective complaints, which were related to lesser stimulation and greater sedation. Nevertheless, 165 min after administration this sedation feeling was less with SMO.IR than with alcohol. There was a significant interaction between SMO.IR and alcohol at 15 min (i.e. increase in alertness and stimulation and decrease in sedation). In addition, an isolated mild decrease in digit vigilance accuracy occurred at 165 min post-dose after the combination. The co-administration of SMO.IR and alcohol was safe and well-tolerated. CONCLUSION SMO.IR and alcohol have distinct adverse effect profiles. The objective effects of SMO.IR are much less marked than those of alcohol. No deleterious interaction was observed.
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Side-alternating vibration training for balance and ankle muscle strength in untrained women.
Spiliopoulou, SI, Amiridis, IG, Tsigganos, G, Hatzitaki, V
Journal of athletic training. 2013;(5):590-600
Abstract
CONTEXT Side-alternating vibration (SAV) may help reduce the risk of falling by improving body balance control. Such training has been promoted as a strength-training intervention because it can increase muscle activation through an augmented excitatory input from the muscle spindles. OBJECTIVE To determine the effect of SAV training on static balance during 3 postural tasks of increasing difficulty and lower limb strength. DESIGN Randomized controlled clinical trial. SETTING Laboratory. PATIENTS OR OTHER PARTICIPANTS A total of 21 healthy women were divided into training (n = 11; age = 43.35 ± 4.12 years, height = 169 ± 6.60 cm, mass = 68.33 ± 11.90 kg) and control (n = 10; age = 42.31 ± 3.73 years, height = 167 ± 4.32 cm, mass = 66.29 ± 10.74 kg) groups. INTERVENTION(S): The training group completed a 9-week program during which participants performed 3 sessions per week of ten 15-second isometric contractions with a 30-second active rest of 3 exercises (half-squat, wide-stance squat, 1-legged half-squat) on an SAV plate (acceleration = 0.91-16.3g). The control group did not participate in any form of exercise over the 9-week period. MAIN OUTCOME MEASURE(S): We evaluated isokinetic and isometric strength of the knee extensors and flexors and ankle plantar flexors, dorsiflexors, and evertors. Static balance was assessed using 3 tasks of increasing difficulty (quiet bipedal stance, tandem stance, 1-legged stance). The electromyographic activity of the vastus lateralis, semitendinosus, medial gastrocnemius, tibialis anterior, and peroneus longus was recorded during postural task performance, baseline and pretraining, immediately posttraining, and 15 days posttraining. RESULTS After training in the training group, ankle muscle strength improved (P = .03), whereas knee muscle strength remained unaltered (P = .13). Improved ankle-evertor strength was observed at all angular velocities (P = .001). Postural sway decreased in both directions but was greater in the mediolateral (P < .001) than anteroposterior (P = .02) direction. The electromyographic activity of the peroneus longus increased during the sharpened tandem (P = .001) and 1-legged tasks (P = .007). No changes were seen in the control group for any measures. CONCLUSIONS The SAV training could enhance ankle muscle strength and reduce postural sway during static balance performance. The reduction in mediolateral sway could be associated with the greater use of ankle evertors due to their strength improvement.
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Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial.
Clemson, L, Fiatarone Singh, MA, Bundy, A, Cumming, RG, Manollaras, K, O'Loughlin, P, Black, D
BMJ (Clinical research ed.). 2012;:e4547
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Abstract
OBJECTIVES To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older, high risk people living at home. DESIGN Three arm, randomised parallel trial; assessments at baseline and after six and 12 months. Randomisation done by computer generated random blocks, stratified by sex and fall history and concealed by an independent secure website. SETTING Residents in metropolitan Sydney, Australia. PARTICIPANTS Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months, recruited from Veteran's Affairs databases and general practice databases. Exclusion criteria were moderate to severe cognitive problems, inability to ambulate independently, neurological conditions that severely influenced gait and mobility, resident in a nursing home or hostel, or any unstable or terminal illness that would affect ability to do exercises. INTERVENTIONS Three home based interventions: Lifestyle integrated Functional Exercise (LiFE) approach (n=107; taught principles of balance and strength training and integrated selected activities into everyday routines), structured programme (n=105; exercises for balance and lower limb strength, done three times a week), sham control programme (n=105; gentle exercise). LiFE and structured groups received five sessions with two booster visits and two phone calls; controls received three home visits and six phone calls. Assessments made at baseline and after six and 12 months. MAIN OUTCOME MEASURES Primary measure: rate of falls over 12 months, collected by self report. Secondary measures: static and dynamic balance; ankle, knee and hip strength; balance self efficacy; daily living activities; participation; habitual physical activity; quality of life; energy expenditure; body mass index; and fat free mass. RESULTS After 12 months' follow-up, we recorded 172, 193, and 224 falls in the LiFE, structured exercise, and control groups, respectively. The overall incidence of falls in the LiFE programme was 1.66 per person years, compared with 1.90 in the structured programme and 2.28 in the control group. We saw a significant reduction of 31% in the rate of falls for the LiFE programme compared with controls (incidence rate ratio 0.69 (95% confidence interval 0.48 to 0.99)); the corresponding difference between the structured group and controls was non-significant (0.81 (0.56 to 1.17)). Static balance on an eight level hierarchy scale, ankle strength, function, and participation were significantly better in the LiFE group than in controls. LiFE and structured groups had a significant and moderate improvement in dynamic balance, compared with controls. CONCLUSIONS The LiFE programme provides an alternative to traditional exercise to consider for fall prevention. Functional based exercise should be a focus for interventions to protect older, high risk people from falling and to improve and maintain functional capacity. TRIAL REGISTRATION Australia and New Zealand Clinical Trials Registry 12606000025538.