scholarly journals Effects of HIIT and MIIT Suspension Training Programs on Sleep Quality and Fatigue in Older Adults: Randomized Controlled Clinical Trial

2021 ◽  
Vol 18 (3) ◽  
pp. 1211
Author(s):  
José Daniel Jiménez-García ◽  
Fidel Hita-Contreras ◽  
Manuel Jesús de la Torre-Cruz ◽  
Agustín Aibar-Almazán ◽  
Alexander Achalandabaso-Ochoa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Programs ◽  
The Elderly ◽  
Moderate Intensity ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Post Intervention ◽  
Randomized Controlled

Poor sleep quality lessens general health quality and is related to physical and mental problems. Moreover, fatigue is one of the foremost common complaints in medical care and plays a role in the decreasing quality of life of the older population. For these reasons, the objective of this study was to examine the effect of high- and moderate-intensity interval training programs (HIIT vs. MIIT)—both consisting of twelve weeks of TRX training—on the sleep quality and fatigue levels of the elderly. A randomized controlled clinical trial (NCT03404830) was conducted. A total of 82 subjects were randomized to either a HIIT group (n = 28) that performed a main squat activity with a suspension system, comprising four four-minute intervals between 90–95% of the maximum heart rate (HR), an MIIT group (n = 27) with an intensity of 70% of the maximum HR, and a control group (CG) (n = 27) that continued their daily lifestyle. The two exercise groups trained twice a week for 12 weeks, with each session lasting 45 min. Sleep quality was measured using the Pittsburgh sleep quality index (PSQI), and fatigue was assessed using the fatigue severity scale (FSS). Outcomes were measured before the intervention and after the intervention period. Post-intervention sleep quality measurements revealed a statistically significant interaction regarding group × time (p < 0.005) and fatigue (p = 0.002). Specifically, fatigue decreased in the HIIT group between both measurement moments (p = 0.003). In addition, differences were obtained in the post-intervention measure between the HIIT and MIIT groups (p = 0.013) and HIIT and control (p = 0.029). Our analysis indicates that a population of the elderly showed improvements in sleep quality and fatigue after performing a high-intensity intervention using suspension training (TRX), with markedly better results in the HIIT group.

An open-label, randomized, controlled clinical trial to explore the curative effects between the treatment of capecitabine and andrographolide and the single capecitabine in the patients with pathological and/or histologic diagnosed unresectable, advanced, recurrent, and metastatic colorectal cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. TPS819-TPS819 ◽  
Author(s):  
Yongqian Shu ◽  
Jing Sun ◽  
Peifen Cai ◽  
Weicheng Wang ◽  
Xiao Han ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Target Therapy ◽  
The Elderly ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
Randomized Controlled Clinical Trial ◽  
Open Label ◽  
Randomized Controlled

TPS819 Background: Colorectal cancer (CRC) is one of the most commonly diagnosed solid tumors worldwide. Current therapies for the treatment of CRC mainly comprise fluoropyromidine-based chemotherapies that are used individually or in combination with oxaliplatin or/with target therapy. Andrographolide, a natural diterpenoid from Andrographispaniculata, has been reported to exert antibacterial, antiviral, anti-inflammation and neuroprotectiveactivities. Our previous studies have proved that Andrographolide can inhibit tumor growth in mice at a relatively high dose(about 200 mg/kg).The aim of the study is to make a comparison of PFS, RR, and OS of the elderly CRC between the treatment of xeloda and andrographolide and the signal xeloda.We look forward to these findings highlight the potential possibility of using this natural, safe and relatively inexpensivecompound as potential adjunctive treatments in improving the overall treatment response of patients with CRC in future. Methods: This is an open-label, randomized, controlled clinical trial. Patients older than or equal to 65, by pathological and/or histologic diagnosed unresectable, advanced, recurrent andmetastatic CRC, will be enrolled. These patients’ tumors must be clearly measured by radiographic technology. All cases of chemotherapy patients randomly divided into two groups, experimental group (xeloda with andrographolide): xeloda: 1250mg/m2 , po bid, d1–14, q3w; andrographolide: 500mg, ivd qd, d1–14, q3w; control group (xeloda): 1250mg/m2, po bid, d1–14, q3w, 21d/cycle. After each 2 cycles, patients will be examined by imageological tests (CT and/or MRI) or tumour biomarkers (CEA and CA199) to estimate the curative effects. Until the tumor progression or after 6 cycles, patients will be removed from this study. PFS is set as the primary endpoint while secondary endpoints include overall survival (OS), overall response rate (ORR), and health-related quality of life (HRQoL). Recruitment has begun in Jan 2014 and about 52 patients has joined this study. Clinical trial information: NCT01993472.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique

2021 ◽  
Author(s):  
Elisabeth Maria Balint ◽  
Beate Grüner ◽  
Sophia Haase ◽  
Mandakini Kaw-Geppert ◽  
Julian Thayer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Interleukin 6 ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Single Center ◽  
Paced Breathing ◽  
Randomized Controlled ◽  
Lr Test ◽  
Practice Time

AbstractImportanceVagus nerve stimulation via slow-paced breathing could serve as adjuvant therapeutic approach to reduce excessive inflammation in coronavirus disease 2019 (COVID-19) pneumonia.ObjectiveDoes a slow-paced breathing technique increasing vagal activity reduce Interleukin-6 (IL-6) in patients hospitalized with moderate COVID-19 pneumonia compared to standard care?DesignSingle-center randomized controlled clinical trial with enrolment from February 23rd 2021 through June 17th 2021 and follow-up until July 22nd 2021.SettingWard for infectious diseases and temporary COVID-19 ward, Ulm University Hospital, GermanyParticipantsConsecutive sample of patients hospitalized with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (primary diagnosis). Of 131 patients screened, 48 patients were randomized and 46 patients analyzed (N=23 per group).InterventionsSlow-paced 20-minute breathing exercise three times a day with six breaths per minute (inhale-to-exhale ratio 4:6).Main outcomes and measuresDifferences between intervention and control group in IL-6 calculated using multilevel mixed-effect linear regression models with random slope including the covariates relevant comorbidities, COVID-19 medication, and age.ResultsMean age 57 years±13 years, N= 28 (60%) male, N=30 (65%) with relevant comorbidities. The model including group by time interaction revealed a significantly lower trajectory of IL-6 in the intervention group compared to the control group (effect size Cohens f2=0.11, LR-test p=.040) in the intention-to-treat sample, confirmed by treatment-per-protocol analysis (f2=0.15, LR-test p=.022).Exploratory analysis using the median split of practice time to predict IL-6 of the next morning indicated a dose-response relationship with beneficial effects of practice time above 45 minutes a day.Three patients in each group were admitted at ICU, one died. Oxygen saturation increased during slow-paced breathing (from 95.1%±2.1% to 95.4%±1.6%, p=0.006).Conclusion and relevancePatients practicing slow-paced breathing had significantly lower IL-6 values than controls without relevant side effects. Further trials should evaluate clinical outcomes as well as an earlier start of the intervention, i.e., at symptom onset. This would offer an access to a therapy option not only for high-income, but also for low- and middle-income countries.Trial registrationGerman register of clinical trials (ID: DRKS00023971) https://www.drks.de, Universal Trial Number (UTN) U1111-1263-8658;Key pointsQuestionCan slow-paced breathing reduce Interleukin-6 (IL-6) in hospitalized patients with moderate coronavirus disease 2019 (COVID-19) pneumonia?FindingsSingle-center randomized controlled clinical trial including 46 patients hospitalized with moderate COVID-19 pneumonia. Compared to controls, IL-6 values were significantly lower (small-to-medium effect sizes) in patients who were instructed to practice six breaths per minute for 20 minutes three times a day. More minutes of slow-paced breathing were significantly correlated with lower IL-6 values the next morning.MeaningSlow-paced breathing could be a safe and feasible adjuvant therapeutic approach in moderate COVID-19 pneumonia.

scholarly journals Effect of N-acetylcysteine on remission maintenance in patients with ulcerative colitis: A Randomized controlled clinical trial

2020 ◽  
Author(s):  
Kourosh Masnadi Shirazi ◽  
Simin Sotoudeh ◽  
Arman Masnadi Shirazi ◽  
Seyyed-Yaghoub Moaddab ◽  
Zahra Nourpanah ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trial ◽  
Placebo Group ◽  
Fecal Calprotectin ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Remission Maintenance ◽  
Hs Crp

Abstract Background: The use of antioxidant agents is suggested as a complementary therapy in UC patients for prevention of flares. Considering the potent antioxidant activity of N-acetylcysteine (NAC), in the present study we aimed to assess the effect of this supplement on remission maintenance in patients with ulcerative colitis (UC). Methods: In the present double-blind randomized controlled clinical trial, 168 volunteer UC patients who were on high dose corticosteroid for flare-up management, were recruited. The patients received 400 mg NAC or placebo twice daily for 16 weeks. Simultaneously, the prednisolone dose was tapered. The patients were followed up six more weeks post-intervention. The primary efficacy of the treatment was remaining in remission. The secondary outcomes were the endoscopic relapse, serum level of hs-CRP, hemoglobin, and fecal calprotectin level. Results: During 22 weeks follow up, 25 patients experienced relapses, six of them were in the NAC group and 19 of them were in the placebo group. There was a significant difference between the NAC and placebo groups regarding the relapse-free period (P=0.007). Compared with the NAC group, significantly more patients in the placebo group had an endoscopic relapse (p <0.001). At the end of the intervention period (16 weeks) and 6 weeks post-intervention, the mean fecal calprotectin, serum erythrocyte sedimentation rate, and hs-CRP levels were significantly lower in the NAC group compared with the placebo group (p<0.05). Conclusion: The findings indicated that NAC had a significantly more positive effect on the maintenance of remission compared with placebo in UC patients that were in the steroid-tapering phase of therapy.

scholarly journals Effect of Physical Therapy on Bone Remodelling in Preterm Infants. A Multicenter Randomized Controlled Clinical Trial

2022 ◽  
Author(s):  
Galaad Torró-Ferrero ◽  
Francisco Javier Fernández-Rego ◽  
Rosario Jiménez-Liria ◽  
Juan Jose Agüera-Arenas ◽  
Jessica Piñero-Peñalver ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Bone Formation ◽  
Preterm Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Bone Modeling ◽  
Randomized Controlled Clinical Trial ◽  
Bone Biomarkers ◽  
Randomized Controlled

Abstract Background: Preterm infants have a low level of bone mineralization compared to those born at term, since 80% of calcium incorporation occurs at the end of pregnancy. The purpose of the present study was to investigate the effect of reflex locomotion therapy on bone modeling and growth in preterm infants and to compare its effect with those of other Physiotherapy modalities.Methods: A multicentre randomized controlled clinical trial was conducted (02/2016 – 07/2020). 106 preterm infants born at the Virgen de la Arrixaca University Clinical Hospital, the General University Hospital of Elche and the Torrecárdenas Hospital in Almería, between 29 and 34 weeks with hemodynamic stability, complete enteral nutrition and without any metabolic, congenital, genetic, neurological or respiratory disorders were evaluated for inclusion. Infants were randomly assigned to three groups: one group received reflex locomotion therapy (EGrlt); another group received passive mobilizations with gentle joint compression (EGpmc); and the control group received massage (CG). All treatments were carried out in the neonatal units lasting one month. The main outcome measure was bone formation and resorption measured with bone biomarkers. A mixed ANOVA was used to compare the results of bone biomarkers, and anthropometric measurements. Results: Infants were randomized to EGrlt (n = 38), EGpmc (n = 32), and CG (n = 36). All groups were similar in terms of gender (p = 0.891 female 47.2%), gestational age (M = 30.753, SD = 1.878, p = 0.39) and birth weight (M = 1413.45, SD = 347.36, p = 0.157). At the end of the study, significant differences were found between the groups in their interaction in bone formation, measured with osteocalcin [F (2,35) = 4.92, p = 0.013, ηp2 = 0.043], in benefit of the EGrlt. Conclusions: Reflex locomotion therapy has been effective in improving bone formation, more so than other Physiotherapy modalities. Therefore, reflex locomotion therapy could be considered one of the most effective physiotherapeutic modalities for the prevention and treatment of osteopenia of prematurity Trial registrstion: Trial retrospectively registered at ClinicalTrials.gov. First posted on 22/04/2020. Registration number: NCT04356807. URL: https://clinicaltrials.gov/ct2/show/NCT04356807?cond=Physical+Therapy+to+Prevent+Osteopenia+in+Preterm+Infants&draw=2&rank=1

scholarly journals Randomized Controlled Clinical Trial of Nanostructured Carbonated Hydroxyapatite for Alveolar Bone Repair

Materials ◽  
2019 ◽  
Vol 12 (22) ◽  
pp. 3645 ◽  
Author(s):  
Rodrigo F. B. Resende ◽  
Suelen C. Sartoretto ◽  
Marcelo J. Uzeda ◽  
Adriana T. N. N. Alves ◽  
José A. Calasans-Maia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bone Repair ◽  
Alveolar Bone ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Socket Preservation ◽  
Carbonated Hydroxyapatite ◽  
Randomized Controlled

The properties of the biodegradation of bone substitutes in the dental socket after extraction is one of the goals of regenerative medicine. This double-blind, randomized, controlled clinical trial aimed to compare the effects of a new bioabsorbable nanostructured carbonated hydroxyapatite (CHA) with a commercially available bovine xenograft (Bio-Oss®) and clot (control group) in alveolar preservation. Thirty participants who required tooth extraction and implant placement were enrolled in this study. After 90 days, a sample of the grafted area was obtained for histological and histomorphometric evaluation and an implant was installed at the site. All surgical procedures were successfully carried out without complications and none of the patients were excluded. The samples revealed a statistically significant increase of new bone formation (NFB) in the CHA group compared with Bio-Oss® after 90 days from surgery (p < 0.05). However, the clot group presented no differences of NFB compared to CHA and Bio-Oss®. The CHA group presented less amount of reminiscent biomaterial compared to Bio-Oss®. Both biomaterials were considered osteoconductors, easy to handle, biocompatible, and suitable for alveolar filling. Nanostructured carbonated hydroxyapatite spheres promoted a higher biodegradation rate and is a promising biomaterial for alveolar socket preservation before implant treatment.

Effect of orange peel essential oil on postpartum sleep quality: A randomized controlled clinical trial

2016 ◽  
Vol 8 (1) ◽  
pp. 62-66 ◽  
Author(s):  
Mojgan Mirghafourvand ◽  
Sakineh Mohammad-Alizadeh Charandabi ◽  
Sevil Hakimi ◽  
Laleh Khodaie ◽  
Mina Galeshi
Keyword(s):  
Clinical Trial ◽  
Essential Oil ◽  
Sleep Quality ◽  
Orange Peel ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled

scholarly journals Development of Cognitive Abilities through the Abacus in Primary Education Students: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 11 (2) ◽  
pp. 83
Author(s):  
Samuel P. León ◽  
María del Carmen Carcelén Fraile ◽  
Inmaculada García-Martínez
Keyword(s):  
Clinical Trial ◽  
Cognitive Abilities ◽  
Auditory Memory ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
School Students ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
The Difference

(1) Background: An abacus is an instrument used to perform different arithmetic operations. The objective was to analyze the benefits of mathematical calculations made with an abacus to improve the concentration, attention, memory, perceptive attitudes, and creativity cognitive abilities of primary school students. (2) Methods: A total of 65 children, aged 7–11 years (8.49 ± 1.65) participated in this randomized controlled clinical trial. The children were randomly distributed into a control group (n = 34) and experimental group (n = 31). The questionnaires used were the D2 test to measure attention and concentration, the Difference Perception Test (FACE-R) test for the perception of differences, the test of immediate auditory memory (AIM), and the test to evaluate creative intelligence (CREA). (3) Results: No significant differences were found between both groups before the intervention. Significant improvements were observed in the cognitive parameters of concentration, memory, perceptive attitudes, and creativity after the intervention, using the abacus, with respect to the control group. (4) Conclusions: It is demonstrated that a calculation program based on the use of the abacus for 8 weeks has beneficial effects on the cognitive capacities of concentration, immediate auditory memory, perceptive attitudes, and creativity. In addition, the benefits of using the abacus to improve cognitive attitudes are reported.

Sign in / Sign up

Export Citation Format

Share Document