scholarly journals Running barefoot leads to lower running stability compared to shod running - results from a randomized controlled study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Karsten Hollander ◽  
Daniel Hamacher ◽  
Astrid Zech
Keyword(s):  
Controlled Trial ◽  
Drop Out ◽  
Treadmill Running ◽  
Measurement Unit ◽  
Controlled Study ◽  
Local Dynamic ◽  
Long Term Effects ◽  
Barefoot Running ◽  
Random Intercept ◽  
Short Time

AbstractLocal dynamic running stability is the ability of a dynamic system to compensate for small perturbations during running. While the immediate effects of footwear on running biomechanics are frequently investigated, no research has studied the long-term effects of barefoot vs. shod running on local dynamic running stability. In this randomized single-blinded controlled trial, young adults novice to barefoot running were randomly allocated to a barefoot or a cushioned footwear running group. Over an 8-week-period, both groups performed a weekly 15-min treadmill running intervention in the allocated condition at 70% of their VO2 max velocity. During each session, an inertial measurement unit on the tibia recorded kinematic data (angular velocity) which was used to determine the short-time largest Lyapunov exponents as a measure of local dynamic running stability. One hundred running gait cycles at the beginning, middle, and end of each running session were analysed using one mixed linear multilevel random intercept model. Of the 41 included participants (48.8% females), 37 completed the study (drop-out = 9.7%). Participants in the barefoot running group exhibited lower running stability than in the shod running group (p = 0.037) with no changes during the intervention period (p = 0.997). Within a single session, running stability decreased over the course of the 15-min run (p = 0.012) without differences between both groups (p = 0.060). Changing from shod to barefoot running reduces running stability not only in the acute phase but also in the longer term. While running stability is a relatively new concept, it enables further insight into the biomechanical influence of footwear.

scholarly journals Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study

2021 ◽  
Author(s):  
Nien Xiang Tou ◽  
Shiou-Liang Wee ◽  
Wei Ting Seah ◽  
Daniella Hui Min Ng ◽  
Benedict Wei Jun Pang ◽  
...  
Keyword(s):  
Older Adults ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Controlled Study ◽  
Power Training ◽  
Frail Older Adults ◽  
Frailty Status ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

AbstractTranslation of community-based functional training for older adults to reduce frailty is still lacking. We evaluated the effectiveness and implementation of a community-delivered group-based functional power training (FPT) program for frail older adults within their neighborhoods. A two-arm, multicenter assessor-blind stratified randomized controlled trial was conducted at four local senior activity centers in Singapore. Sixty-one community-dwelling older adults with low handgrip strength were randomized to intervention (IG) or control (CG) group. The IG underwent the FPT program (power and balance exercises using simple equipment) delivered by a community service provider. The 12-week program comprised 2 × 60 min sessions/week. CG continued usual activities at the centers. Functional performance, muscle strength, and frailty status were assessed at baseline and 3 months. Program implementation was evaluated using RE-AIM framework. The program was halted due to Coronavirus Disease 2019-related suspension of senior center activities. Results are reported from four centers, which completed the program. IG showed significantly greater improvement in the Short Physical Performance Battery test as compared to CG (p = 0.047). No effects were found for timed up and go test performance, muscle strength, and frailty status. The community program exhibited good reach, effectiveness, adoption, and implementation. Our study demonstrated that FPT was associated with greater improvement in physical function in pre-frail/frail participants as compared to exercise activities offered at local senior activity centers. It is a feasible intervention that can be successfully implemented for frail older adults in their neighborhoods. Trial registration ClinicalTrials.gov, NCT04438876. Registered 19 June 2020–retrospectively registered.

scholarly journals Transcutaneous Electrical Acupoint Stimulation Reduces Postoperative Analgesic Requirement in Patients Undergoing Inguinal Hernia Repair: A Randomized, Placebo-Controlled Study

2021 ◽  
Vol 10 (1) ◽  
pp. 146
Author(s):  
Mateusz Szmit ◽  
Siddarth Agrawal ◽  
Waldemar Goździk ◽  
Andrzej Kübler ◽  
Anil Agrawal ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Inguinal Hernia ◽  
Side Effects ◽  
Hernia Repair ◽  
Inguinal Hernia Repair ◽  
Adverse Drug Events ◽  
Controlled Trial ◽  
Controlled Study ◽  
Anesthetic Technique ◽  
Analgesic Requirement

Given the rising rate of opioid-related adverse drug events during postsurgical pain management, a nonpharmacologic therapy that could decrease analgesic medication requirements would be of immense value. We designed a prospective, placebo-and-randomized controlled trial to assess the clinical effect of transcutaneous acupoint electrical stimulation (TEAS) on the postoperative patient-controlled analgesia (PCA) requirement for morphine, as well as side effects and recovery profile after inguinal hernia repair. Seventy-one subjects undergoing inguinal hernia repair with a standardized anesthetic technique were randomly assigned to one of three analgesic treatment regimens: PCA + TEAS (n = 24); PCA + sham-TEAS (no electrical stimulation) (n = 24), and PCA only (n = 23). The postoperative PCA requirement, pain scores, opioid-related side effects, and blood cortisol levels were recorded. TEAS treatment resulted in a twofold decrease in the analgesic requirement and decreased pain level reported by the patients. In addition, a significant reduction of cortisol level was reported in the TEAS group at 24 h postoperatively compared to the sham and control groups. We conclude that TEAS is a safe and effective option for reducing analgesic consumption and postoperative pain following inguinal hernia repair.

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals Impacts of treatments on recurrence and 28-year survival of ischemic stroke patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ting-Ann Wang ◽  
Tzy-Haw Wu ◽  
Shin-Liang Pan ◽  
Hsiu-Hsi Chen ◽  
Sherry Yueh-Hsia Chiu
Keyword(s):  
Ischemic Stroke ◽  
Cerebrovascular Disease ◽  
Cox Regression ◽  
Controlled Trial ◽  
Stroke Recurrence ◽  
Long Term Effects ◽  
Stroke Patients ◽  
Double Blind ◽  
Term Survival

AbstractAspirin and nicametate are well-established therapies for preventing recurrence and mortality from stroke in patients diagnosed as ischemic stroke. However, their respective effects on the recurrence, making allowance for the duration of recurrence and death without the occurrence of recurrence, and long-term survival have not been well elucidated. We aimed to evaluate long-term effect of two kinds of treatment on cerebrovascular death among ischemic stroke patients with or without the recurrence of stroke. Data used in this study were derived from the cohort based on a multicenter randomized double-blind controlled trial during 1992 to 1995 with the enrollment of a total of 466 patients with first-time non-cardioembolic ischemic stroke who were randomly allocated to receive aspirin (n = 222) or nicametate (n = 244). The trial cohort was followed up over time to ascertain the date of recurrence within trial period and death until Sep of 2019. The time-dependent Cox regression model was used to estimate the long-term effects of two treatments on death from cerebrovascular disease with and without recurrence. A total of 49 patients experienced stroke recurrence and 89 cerebrovascular deaths was confirmed. Patients treated with nicametate were more likely, but non statistically significantly, to have recurrence (aHR: 1.73, 95% CI 0.96–3.13) as compared with those treated by aspirin. Nicametate reduced the risk of cerebrovascular death about 37% (aHR: 0.63, 95% CI 0.41–0.97) compared with aspirin. The aspirin group had a lower recurrence rate than the nicametate group even with recurrence after 1–2 years of follow-up of first stroke but the latter had significantly reduced death from cerebrovascular disease for nicametate group, which requires more research to verify.

scholarly journals Comparison of Lateral Perturbation-Induced Step Training and Hip Muscle Strengthening Exercise on Balance and Falls in Community-Dwelling Older Adults: A Blinded Randomized Controlled Trial

2021 ◽  
Author(s):  
Mark W Rogers ◽  
Robert A Creath ◽  
Vicki Gray ◽  
Janice Abarro ◽  
Sandy McCombe Waller ◽  
...  
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Step Length ◽  
Community Dwelling ◽  
Controlled Study ◽  
Balance Performance ◽  
Muscle Strengthening ◽  
Hip Muscle ◽  
Hip Abduction ◽  
Community Dwelling Older Adults

Abstract Background This factorial, assessor-blinded, randomized, and controlled study compared the effects of perturbation-induced step training (lateral waist-pulls), hip muscle strengthening, and their combination, on balance performance, muscle strength, and prospective falls among older adults. Methods Community-dwelling older adults were randomized to 4 training groups. Induced step training (IST, n = 25) involved 43 progressive perturbations. Hip abduction strengthening (HST, n = 25) utilized progressive resistance exercises. Combined training (CMB, n = 25) included IST and HST, and the control performed seated flexibility/relaxation exercises (SFR, n = 27). The training involved 36 sessions for a period of 12 weeks. The primary outcomes were the number of recovery steps and first step length, and maximum hip abduction torque. Fall frequency during 12 months after training was determined. Results Overall, the number of recovery steps was reduced by 31% and depended upon the first step type. IST and CMB increased the rate of more stable single lateral steps pre- and post-training than HST and SFR who used more multiple crossover and sequential steps. The improved rate of lateral steps for CMB exceeded the control (CMB/SFR rate ratio 2.68). First step length was unchanged, and HST alone increased hip torque by 25%. Relative to SFR, the fall rate ratios (falls/person/year) [95% confidence interval] were CMB 0.26 [0.07–0.90], IST 0.44 [0.18–1.08], and HST 0.30 (0.10–0.91). Conclusions Balance performance through stepping was best improved by combining perturbation and strength training and not strengthening alone. The interventions reduced future falls by 56%–74% over the control. Lateral balance perturbation training may enhance traditional programs for fall prevention.

scholarly journals Switching from TNFα inhibitor to tacrolimus as maintenance therapy in rheumatoid arthritis after achieving low disease activity with TNFα inhibitors and methotrexate: 24-week result from a non-randomized, prospective, active-controlled trial

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Sang Youn Jung ◽  
Jung Hee Koh ◽  
Ki-Jo Kim ◽  
Yong-Wook Park ◽  
Hyung-In Yang ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Maintenance Therapy ◽  
Disease Activity ◽  
Controlled Trial ◽  
Tumor Necrosis Factor Inhibitor ◽  
Controlled Study ◽  
Open Label ◽  
Low Disease Activity ◽  
Efficacy Analysis ◽  
Tnfα Inhibitor

Abstract Background Tapering or stopping biological disease-modifying anti-rheumatic drugs has been proposed for patients with rheumatoid arthritis (RA) in remission, but it frequently results in high rates of recurrence. This study evaluates the efficacy and safety of tacrolimus (TAC) as maintenance therapy in patients with established RA in remission after receiving combination therapy with tumor necrosis factor inhibitor (TNFi) and methotrexate (MTX). Methods This 24-week, prospective, open-label trial included patients who received TNFi and MTX at stable doses for ≥24 weeks and had low disease activity (LDA), measured by Disease Activity Score-28 for ≥12 weeks. Patients selected one of two arms: maintenance (TNFi plus MTX) or switched (TAC plus MTX). The primary outcome was the difference in the proportion of patients maintaining LDA at week 24, which was assessed using a logistic regression model. Adverse events were monitored throughout the study period. Results In efficacy analysis, 80 and 34 patients were included in the maintenance and switched arms, respectively. At week 24, LDA was maintained in 99% and 91% of patients in the maintenance and switched arms, respectively (odds ratio, 0.14; 95% confidence interval, 0.01–1.59). Drug-related adverse effects tended to be more common in the switched arm than in the maintenance arm (20.9% versus 7.1%, respectively) but were well-tolerated. Conclusion This controlled study tested a novel treatment strategy of switching from TNFi to TAC in RA patients with sustained LDA, and the findings suggested that TNFi can be replaced with TAC in most patients without the patients experiencing flare-ups for at least 24 weeks. Trial registration Korea CDC CRIS, KCT0005868. Registered 4 February 2021—retrospectively registered

scholarly journals Long-Term Effects on Loneliness of a Computer-Tailored Intervention for Older Adults With Chronic Diseases: A Randomized Controlled Trial

2021 ◽  
pp. 089826432110150
Author(s):  
Janet M. Boekhout ◽  
Esmee Volders ◽  
Catherine A. W. Bolman ◽  
Renate H. M. de Groot ◽  
Lilian Lechner
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Chronic Diseases ◽  
Controlled Trial ◽  
Social Activity ◽  
Time Frame ◽  
Future Research ◽  
Long Term Effects ◽  
Randomized Controlled ◽  
Social Loneliness

Objectives: This study explores the effects of the Active Plus intervention aiming to decrease loneliness among older adults (>65 years) with chronic diseases. Methods: A randomized controlled trial (RCT) was performed (N = 585; age: M = 74.5 years, SD = 6.4), assessing loneliness at baseline, 6 months and 12 months. Outcome measures in the multilevel linear regression analyses were total, social and emotional loneliness. Results: At 12 months, significant decreases in total ( B = −.37, p = .01) and social loneliness ( B = −.24, p = .02) were found. Age was a significant moderator for total and social loneliness; however, the intervention was effective only for participants aged 80 years and older. Discussion: The Active Plus intervention showed a significant decrease in total and social loneliness and was especially beneficial for the vulnerable age group of 80 years and older. A more comprehensive tool for measuring social activity and mobility impairments, and using a longer time frame to detect loneliness changes, may form interesting future research.

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