Participation outcomes differed between video game-based balance training and standard of care training: Pilot clinical trial

Abstract Background Hospitalization is a profound contributor to functional loss for older adults. Many modifiable risk factors (ie, weakness) may persist after hospitalization, representing portents of poor health, re-hospitalization, or death. Older adults frequently receive home health (HH) care after hospitalization to manage functional deficits that have worsened during hospital stays. However, how best to manage these deficits in HH settings has yet to be determined. Objective The objective is to determine if a higher intensity, progressive, multi-component (PMC) intervention, initiated upon admission to HH after an acute hospitalization, improves objectively measured and self-reported physical function more than usual care (UC) physical therapy. Design This will be a 2-arm randomized controlled clinical trial. Setting The setting will be participant homes. Participants A total of 200 older adults with deconditioning following acute hospitalization and referred for HH physical therapy will participate. Intervention Participants will be randomized to either a PMC treatment group or a UC group and receive 12 therapy visits over a 60-day period. PMC participants will perform lower extremity resistance training at 80% of a 1-repetition maximum, task-specific activities of daily living training, along with advanced gait and balance training. PMC groups will also receive nutritional supplementation and nursing support during transition from hospital to home. The UC group will receive standard of care HH interventions. Measurements Physical performance, self-reported function, fatigue, and health care utilization outcomes will be measured at baseline, 30 days, 60 days, 90 days, and 180 days. All measures will be assessed by blinded study personnel. Limitations The limitation is an inability to blind treating therapists to study allocation. Conclusions The authors hope to determine whether higher intensity, multi-component exercise interventions improve outcomes more than UC physical therapy for older adults recovering from acute hospitalization in HH settings.

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Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

Trials ◽

10.1186/s13063-021-05033-x ◽

2021 ◽

Vol 22 (1) ◽

Cited By ~ 1

Author(s):

Iwein Gyselinck ◽

◽

Laurens Liesenborghs ◽

Ewout Landeloos ◽

Ann Belmans ◽

...

Keyword(s):

Clinical Trial ◽

Standard Of Care ◽

Ordinal Scale ◽

Cytokine Signaling ◽

Nasopharyngeal Swab ◽

The Novel ◽

Proof Of Concept ◽

Open Label ◽

Novel Coronavirus

Abstract Background The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. Methods DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician’s discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. Discussion The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. Trial registration EU Clinical trials register EudraCT Nb 2020-001614-38. Registered on 22 April 2020

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AEROBIC EXERCISE VOLUME, NOT PRESCRIPTION, INFLUENCES POST-CONCUSSION SYMPTOMS: A RANDOMIZED CLINICAL TRIAL

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967121s00048 ◽

2021 ◽

Vol 9 (7_suppl3) ◽

pp. 2325967121S0014

Author(s):

David R. Howell ◽

Danielle Hunt ◽

Stacey E. Aaron ◽

William P. Meehan ◽

Can Ozan Tan

Keyword(s):

Clinical Trial ◽

Aerobic Exercise ◽

Symptom Severity ◽

Exercise Prescription ◽

Standard Of Care ◽

Care Group ◽

Initial Symptom ◽

Initial Visit ◽

Severity Scores ◽

Text Figure

Background: Current recommendations for sport-related concussion uniformly emphasize the importance of physical activity. However, specifics of this recommendation remain vague and do not account for an exercise dosage or compliance. Purposes: First, we examined if an 8-week individualized sub-symptom threshold aerobic exercise prescription, initiated within the first two weeks of concussion, alleviates symptom severity or affects the amount of exercise performed during the study. Second, we examined whether prescription adherence, rather than randomized group assignment, reflects the actual impact of aerobic exercise in post-concussion recovery. Methods: For this single-site prospective randomized clinical trial, participants completed an aerobic exercise test within 14 days of injury, and were randomized to an individualized aerobic exercise program or standard-of-care, and returned for assessments 1 month and 2 months after the initial visit (Table 1). The aerobic exercise group was instructed to exercise 5 days/week, 20 minutes/day, at a target heart rate based on an exercise test at the initial visit. Participants reported their symptom exercise volume each week over the 8-week study period, and reported symptoms at each study visit (initial, 1 month, 2 month). Results: Initial symptom severity was not different between randomized groups (Figure 1A), and no significant differences in symptom severity were found at the 4-week (Figure 1B) or 8-week (Figure 1C) assessment. In addition, there was no significant differences between groups for average weekly exercise volume during the first four weeks (Figure 2A) or second four weeks (Figure 2B) of the study. During the first four weeks of the study, 65% (n=11/17) of the exercise intervention participants were compliant with their exercise recommendation (≥100 min/week), compared to 45% (n=9/20) of the standard-of-care group (p=0.33). During the second four weeks of the study, 71% (n=12/17) of the exercise prescription group exercised ≥100 min/week, compared to 55% (n=11/20) of the standard-of-care group (p=0.50). When grouped by exercise volume, the group who exercised ≥100 minutes/week during the first month of the study reported significantly lower symptom severity scores than those who exercised <100 minutes/week (Figure 3B), despite similar initial symptom severity scores (Figure 3A). Conclusion: Participant randomization within 14 days of concussion did not lead to a significant reduction in symptoms, or greater exercise volume. Given that greater exercise volume was associated with lower symptoms after one month of the study, researchers and clinicians should pay particular attention to adherence to aerobic exercise programs for the treatment of concussion. [Table: see text][Figure: see text][Figure: see text][Figure: see text]

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Alexander Technique vs. Targeted Exercise for Neck Pain—A Preliminary Comparison

Applied Sciences ◽

10.3390/app11104640 ◽

2021 ◽

Vol 11 (10) ◽

pp. 4640

Author(s):

Jordan J. Becker ◽

Tara L. McIsaac ◽

Shawn L. Copeland ◽

Rajal G. Cohen

Keyword(s):

Neck Pain ◽

Video Game ◽

Cost Effective ◽

Standard Of Care ◽

Chronic Neck Pain ◽

Exercise Group ◽

Alexander Technique ◽

Private Lessons ◽

Pain Disability ◽

Exercise Class

Background: Alexander technique private lessons have been shown to reduce chronic neck pain and are thought to work by different mechanisms than exercise. Group classes may also be effective and would be cost-effective. Design: A two-group pre-test/post-test design. Participants were assigned to either a general Alexander technique class or an exercise class designed to target neck pain. Both groups met over 5 weeks for two 60 min sessions/week. Participants: A total of 16 participants with chronic neck pain (aged 50+/−16 years) completed this study. Interventions: The Alexander class used awareness-building methods to teach participants to reduce habitual tension during everyday activities. The exercise class was based on physical therapy standard of care to strengthen neck and back muscles thought to be important for posture. Measures: We assessed neck pain/disability, pain self-efficacy, activation of the sternocleidomastoid muscles during the cranio-cervical flexion test, and posture while participants played a video game. Results: Both groups reported decreased neck pain/disability after the interventions. Sternocleidomastoid activation decreased only in the Alexander group. Conclusion: In this small preliminary study, Alexander classes were at least as effective as exercise classes in reducing neck pain and seemed to work via a different mechanism. Larger, multi-site studies are justified.

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Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

10.1101/2020.08.26.20182444 ◽

2020 ◽

Cited By ~ 7

Author(s):

Cristina Avendano-Sola ◽

Antonio Ramos-Martinez ◽

Elena Munez-Rubio ◽

Belen Ruiz-Antoran ◽

Rosa Malo de Molina ◽

...

Keyword(s):

Clinical Trial ◽

Mechanical Ventilation ◽

Randomized Clinical Trial ◽

Strong Dependence ◽

Standard Of Care ◽

Ordinal Scale ◽

Control Group ◽

Standard Of Care Treatment ◽

And Control ◽

To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

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Examining the effects of active video games and balance training on static balance in 6 years old children6 yaş grubu çocuklarda aktif video oyunları ve denge antrenmanlarının statik dengeye etkisinin incelenmesi

Journal of Human Sciences ◽

10.14687/jhs.v15i4.5435 ◽

2018 ◽

Vol 15 (4) ◽

pp. 2376

Author(s):

Abdurrahman Demir ◽

Manolya Akın

Keyword(s):

Video Games ◽

Video Game ◽

Balance Training ◽

Control Group ◽

Static Balance ◽

Nintendo Wii ◽

Active Video Games ◽

Significant Difference ◽

Active Video Game ◽

Active Video

The purpose of this study was to examine the effects of active video games Nintendo Wii and Wobel Board balance exercises on static balance development in children aged 6 years. 54 children, participated in the research voluntarily on informed consents from according to Helsinki criteria by taking permission from Mersin University Ethics Committe. The study was carried out with 3 groups with similar physical characteristics (mean age = 6,21, mean weight= 21,3, mean height = 116,8). The balance training were applied to a group with a 'wobble board' and another group with a 'nintendo wii game console' from active video games. The pre and post test static balance measurements of all groups were measured using the 'Balance Error Scoring System' and the differences between the groups were examined. For parametric results, 3x2 repetitive measurements were performed with anova analysis, and for non-parametric results kruskall wallis test was applied. There was no significant difference between the groups participating in active video game and wobble board balance training in the measurements made after the study (p>,05). The difference between the experimental group and the foot and tandem position were found statistically significant. (p <,01). There was no significant difference between the two groups in paired feet values (p>, 05). Both the wobbel board and the active video game training have been found to improve the static balance in children. It has been seen that there is no meaningful development in the control group. This result shows us that active video games are as effective as balance training in 6 years old children. In this context, active video games can be proposed as an alternative method to improve balance.Extended English summary is in the end of Full Text PDF (TURKISH) file. Özet Bu çalışmanın amacı, 6 yaş çocuklarda aktif video oyunları nintendo wii ve wobble board denge antrenmanlarının statik denge gelişimleri üzerine etkisini incelemektir. Araştırmaya, 54 çocuk, Mersin Üniversitesi etik kurulundan izin alınarak Helsinki kriterlerine uygun olarak katılmıştır. Çalışma benzer fiziksel özellikte (yaş ort.=6,21, kilo ort.=21,3, boy ort.=116,8) 3 grupla yürütülmüştür. Denge antrenmanları haftada üç gün 8 hafta ‘wobble board’ denge tahtası ve aktif video oyunları ‘nintendo wii oyun konsolu’ ile uygulanmıştır. Kontrol grubuna ise herhangi bir uygulama yaptırılmamıştır. Tüm grupların statik denge ölçümleri ‘Denge Hata Skoru Sistemi’ kullanılarak ölçülmüştür.Parametrik sonuçlar için, çalışmada 3x2 tekrarlı ölçümler anova analizi yapılmış, non-parametrik sonuçlar için ise kruskall wallis testi uygulanmıştır. Araştırma sonrasında aktif video oyunu ve wobble board denge antrenmanına katılan gruplar arasında istatistiksel olarak manidar fark bulunmamıştır (p>,05). Deney gruplarının, zeminde ve köpükte tek ayak ve tandem duruşlarda bulunan fark kontrol grubuna göre istatistiksel olarak anlamlı (p<,01) iken, çift ayak değerlerinde, üç grup arasında da anlamlı bir fark bulunmamıştır (p>,05). Hem wobble board hem de aktif video oyunları nintendo wii denge antrenmanlarının çocuklarda statik dengeyi geliştirdiği bulunmuştur. Kontrol gurubunda ise anlamlı bir gelişimin olmadığı görülmüştür. Bu sonuç bize aktif video oyunlarının 6 yaş grubu çocuklarda denge antrenmanları kadar etkili olduğunu göstermektedir. Bu bağlamda aktif video oyunları dengeyi geliştirmek için alternatif bir yöntem olarak önerilebilir.

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CTNI-01. A PHASE 1-2 CLINICAL TRIAL OF EO1001 (APL-122), A NOVEL IRREVERSIBLE PAN-ERBB INHIBITOR WITH PROMISING BRAIN PENETRATION

Neuro-Oncology ◽

10.1093/neuonc/noab196.226 ◽

2021 ◽

Vol 23 (Supplement_6) ◽

pp. vi58-vi58

Author(s):

Sophia Frentzas ◽

Gary Richardson ◽

Jeffrey Bacha ◽

Sarath Kanekal ◽

Neil Sankar ◽

...

Keyword(s):

Clinical Trial ◽

Dose Escalation ◽

Phase 1 ◽

Standard Of Care ◽

Maximum Tolerated Dose ◽

Cns Metastases ◽

Once Daily ◽

Adult Participants ◽

Xenograft Models ◽

Cns Penetration

Abstract CNS metastases are a prominent driver of cancer morbidity and mortality, especially as targeted therapies have improved systemic outcomes. Mutations in the ErbB/HER kinase family are known oncodrivers in many cancers. Extensive crosstalk among ErbB/HER receptors suggests that inhibition of multiple family members may benefit treatment and limit drug resistance. There is a desperate need for new agents that are more tolerable and effective in treating CNS metastases. EO1001 (APL-122) is a first-in-class, oral, irreversible pan-ErbB inhibitor targeting ErbB1, ErbB2 and ErbB4 with promising CNS penetration in preclinical models. Preclinical data suggests a favorable pharmacokinetic and safety profile and activity against ErbB-driven cancers in patient-derived xenograft models. We report on a first-in-human Phase 1-2 clinical trial in progress. Adult participants with confirmed ErbB-positive cancer, including patients with CNS involvement, who have progressed after standard-of-care, with adequate bone marrow, renal and liver function are eligible. ESCALATION: One subject per dose cohort is enrolled in an accelerated dose-escalation design until drug-related toxicity (≥G2) is observed in the first cycle, after which dose escalation will revert to a 3 + 3 design to determine the maximum tolerated dose (MTD). Cycle 1: Patients receive a single oral dose of EO1001 on day 1; single-dose pharmacokinetics are measured. Beginning on day 8, EO1001 is administered once daily for 21 days; multi-dose pharmacokinetics are measured. Cycles 2-6: EO1001 is administered once daily in continuous 28-day cycles for up to 20 weeks. EXPANSION: EO1001 will be administered once daily to 20 patients at the MTD in continuous 28-day cycles for up to 6 cycles to determine a recommended Phase 2 dose (RP2D) for further study. Toxicity is assessed based on NCI CTCAEv5 and tumor response is assessed by RECIST 1.1. CNS exposure is evaluated in patients via CSF collection with confirmed CNS disease involvement.

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NRG Oncology HN006: Randomized phase II/III trial of sentinel lymph node biopsy versus elective neck dissection for early-stage oral cavity cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.tps6093 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. TPS6093-TPS6093

Author(s):

Stephen Yenzen Lai ◽

Pedro A. Torres-Saavedra ◽

Neal E. Dunlap ◽

Beth Michelle Beadle ◽

Steven S. Chang ◽

...

Keyword(s):

Clinical Trial ◽

Quality Assurance ◽

Neck Dissection ◽

Phase Ii ◽

Oral Cavity Cancer ◽

Early Stage ◽

Standard Of Care ◽

Phase Iii ◽

Elective Neck Dissection ◽

Pet Ct

TPS6093 Background: Since patients with early-stage oral cavity cancer (OCC; T1-2N0M0; AJCC 8th ed) have a 20-30% rate of occult nodal metastases despite clinical and radiographic assessment, standard of care treatment includes elective neck dissection (END). Many patients have comprehensive surgical management of the regional cervical nodal basin even though the majority of those necks (70-80%) will not contain disease. Assessment of draining first echelon lymph nodes by sentinel lymph node (SLN) biopsy (Bx), a less invasive surgical procedure, may provide an alternative to END, while potentially reducing morbidity and cost. A decisive clinical trial comparing SLN Bx versus END can focus the HNC clinical and research community and resources on establishing the standard of care for management of the neck in early-stage OCC. Methods: In order to address the efficacy of SLN Bx in this population, we recently activated an international multi-institutional phase II/III prospective trial randomizing patients to two surgical arms: SLN Bx and END. PET/CT is an integral imaging biomarker in this trial. A node-negative PET/CT study with central read is required before randomization. Patients with a positive PET/CT central result will remain in a registry to compare imaging findings with final neck pathology. Given the current evidence available regarding morbidity for SLN Bx versus END, the phase II will determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the Neck Dissection Impairment Index (NDII) shows a signal of superiority of SLN Bx compared to END. A total of 228 randomized patients with negative PET/CT for potential evaluation of shoulder-related morbidity with difference in 6-month NDII scores (minimum important difference ³7.5; one-sided a = 0.10; 90% power) will serve as the “Go/No-Go” decision to move forward into phase III. The phase III portion is a non-inferiority (NI) trial with disease-free survival (DFS) as the primary endpoint (NI margin hazard ratio 1.34 based on a 5% absolute difference in 2-year DFS; one-sided alpha 0.05; 80% power, and an interim look for efficacy at 67% of the events based on an O’Brien-Fleming boundary). The NDII at 6 months after surgery is a hierarchical co-primary endpoint for the phase III. Target accrual of phase III is 618 PET/CT negative patients, including those randomized in phase II (297 DFS events required for the final analysis). In addition to radiotherapy and imaging credentialing, quality assurance will include central pathology review of all negative SLN Bx cases and surgeon credentialing through an education course and SLN Bx and END case review by the surgical co-chairs. A surgical quality assurance working group will review all trial SLN Bx and END outcomes. As of 02/15/21, 7 patients have been screened and 6 of the planned 228 randomized patients in phase II have been enrolled. Clinical trial information: NCT04333537.

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NCOG-27. STATUS AS A CLINICAL TRIAL PARTICIPANT AND OUTCOME IN IDH-WILDTYPE GLIOBLASTOMA

Neuro-Oncology ◽

10.1093/neuonc/noab196.618 ◽

2021 ◽

Vol 23 (Supplement_6) ◽

pp. vi157-vi158

Author(s):

Peter Pan ◽

Adela Joanta-Gomez ◽

Fabio Iwamoto ◽

Mary Welch ◽

Aya Haggiagi ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Study ◽

Promoter Methylation ◽

Parietal Lobe ◽

Strong Predictor ◽

Standard Of Care ◽

Mgmt Promoter Methylation ◽

Study Patient ◽

Trial Participant ◽

Mgmt Promoter

Abstract INTRODUCTION Standard of care for glioblastoma consists of surgery, followed by combined chemoradiation and adjuvant chemotherapy, as per the seminal EORTC study from 2005. Clinical trial patients, being a population selected for functional status, hepatic function, renal function, and lack of other malignancies, may have improved outcome over the general treated population. METHOD Single center retrospective analysis of status as a clinical trial patient in the upfront setting and other clinical factors/biomarkers, analyzed for correlation with outcomes (PFS/OS) in IDH-wildtype glioblastomas. RESULTS 82 patients with IDH-wildtype glioblastoma were identified between 2014 and 2020, treated with standard of care or with an upfront clinical study (43% women; median age 66 years, range 35-91 years of age). 22 patients (27%) were treated with upfront clinical study. Status as a patient treated in an upfront clinical study did not correlate with outcome (hazard ratio HR PFS 0.99, CI 0.57-1.7, p=0.97; HR OS 1.09, CI 0.56-2.1, p=0.81). Frontal lobe was most frequently involved (n=36, 44%), followed by parietal lobe (n=33, 40%). Age was not a strong predictor of survival (R2 0.01). No statistically significant correlation was observed between outcome and laterality or location. MGMT promoter methylation was associated with improved PFS (HR 0.56, CI 0.33-0.94, p=0.03) and OS (HR 0.40, CI 0.19-0.85, p=0.02), with mPFS 6 months vs 9 months and mOS 16 months vs 20 months (unmethylated vs methylated respectively). CONCLUSION In this retrospective cohort of IDH-wildtype glioblastomas, age, tumor laterality, and tumor location were not significant predictors of outcome. MGMT promoter methylation predicted for superior PFS/OS. Patient selection for clinical studies are influenced by entry criteria, however at least in this retrospective review, status as a clinical study patient in the upfront setting did not correlate with outcome compared to patients treated with upfront standard of care.

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