Randomized Clinical Trial of Balance-Based Torso Weighting for Improving Upright Mobility in People with Multiple Sclerosis

2009 ◽  
Vol 23 (8) ◽  
pp. 784-791 ◽  
Author(s):  
Gail L. Widener ◽  
Diane D. Allen ◽  
Cynthia Gibson-Horn
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Body Weight ◽  
Randomized Clinical Trial ◽  
Phase 1 ◽  
Gait Velocity ◽  
Control Group ◽  
Phase 2 ◽  
Timed Up And Go ◽  
Standard Weight

Background. Torso weighting has sometimes been effective for improving upright mobility in people with multiple sclerosis, but parameters for weighting have been inconsistent. Objective. To determine whether balance-based torso weighting (BBTW) has immediate effects on upright mobility in people with multiple sclerosis. Methods. This was a 2-phase randomized clinical trial. In phase 1, 36 participants were randomly assigned to experimental and control groups. In phase 2, the control group was subsequently randomized into 2 groups with alternate weight-placement. Tests of upright mobility included: timed up and go (TUG), sharpened Romberg, 360-degree turns, 25-foot walk, and computerized platform posturography. Participants were tested at baseline and again with weights placed according to group membership. In both phases, a physical therapist assessed balance for the BBTW group and then placed weights to decrease balance loss. In phase 1, the control group had no weights placed. In phase 2, the alternate treatment group received standard weight placement of 1.5% body weight. Results. People with BBTW showed a significant improvement in the 25-foot walk ( P = .01) over those with no weight, and the TUG ( P = .01) over those with standard weight placement. BBTW participants received an average of 0.5 kg, less than 1.5% of any participant’s body weight. Conclusion. BBTW can have immediate advantages over a nonweighted condition for gait velocity and over a standardized weighted condition for a functional activity in people with multiple sclerosis (MS) who are ambulatory but have balance and mobility abnormalities.

Beneficial Effects of Adenosine Triphosphate on Nutritional Status in Advanced Lung Cancer Patients: A Randomized Clinical Trial

2002 ◽  
Vol 20 (2) ◽  
pp. 371-378 ◽  
Author(s):  
Hendrik J. Agteresch ◽  
Trinet Rietveld ◽  
Leon G.M. Kerkhofs ◽  
J. Willem O. van den Berg ◽  
J. H. Paul Wilson ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Body Composition ◽  
Body Weight ◽  
Energy Expenditure ◽  
Randomized Clinical Trial ◽  
Energy Intake ◽  
Advanced Lung Cancer ◽  
Control Group ◽  
Muscle Area

PURPOSE: In a randomized clinical trial in patients with advanced non–small-cell lung cancer (NSCLC), infusion with adenosine 5′-triphosphate (ATP) inhibited loss of body weight and quality of life. In the present article, the effects of ATP on body composition, energy intake, and energy expenditure as secondary outcome measures in the same patients are reported. PATIENTS AND METHODS: Patients with NSCLC, stage IIIB or IV, were randomized to receive either 10 intravenous, 30-hour ATP infusions every 2 to 4 weeks or no ATP. Fat mass (FM), fat-free mass (FFM), and arm muscle area were assessed at 4-week intervals for 28 weeks. Food intake, body cell mass (BCM), and resting energy expenditure (REE) were assessed at 8-week intervals for 16 weeks. Between-group differences were tested for statistical significance by repeated-measures analysis of covariance. RESULTS: Fifty-eight patients were randomized (28 ATP, 30 control). No change in body composition over the 28-week follow-up period was found in the ATP group, whereas, per 4 weeks, the control group lost 0.6 kg of FM (P = .004), 0.5 kg of FFM (P = .02), 1.8% of arm muscle area (P = .02), and 0.6% of BCM/kg body weight (P = .054) and decreased 568 KJ/d in energy intake (P = .0001). Appetite also remained stable in the ATP group but decreased significantly in the control group (P = .0004). No significant differences in REE between the ATP and control groups were observed. CONCLUSION: The inhibition of weight loss by ATP infusions in patients with advanced NSCLC is attributed to counteracting the loss of both metabolically active and inactive tissues. These effects are partly ascribed to maintenance of energy intake.

scholarly journals Effects of aquatic physiotherapy versus conventional physical therapy on the risk of fall in the elderly: a randomized clinical trial

2020 ◽  
Vol 21 (3) ◽  
pp. 253
Author(s):  
Christye Ramos Da Silva ◽  
Leonardo Farias Rodrigues Magalhães ◽  
Fernanda Manaia Gonçalves Chaves ◽  
Erica Cardaretti do Nascimento Vieira ◽  
Ana Paula Radies Adames ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Gait Speed ◽  
The Elderly ◽  
Individual Treatment ◽  
Control Group ◽  
Timed Up And Go ◽  
Motor Abilities ◽  
Risk Of Fall

Objective: To identify whether physiotherapy treatment in water is more effective than the treatment in land environment, aiming at improving the process of physical limitation or functional inability (gait speed, balance, motor abilities) caused by lack of balance in elderly with risk of fall. Methods: Randomized clinical trial, experimental study. The sample was composed of 35 senior individuals of both sexes, with average age of 65. Nineteen people composed the control Group /Conventional Physiotherapy, while the rest composed the experimental Group/Aquatic Physical therapy. Both groups were submitted to twenty sessions of physical therapy, twice a week, for 50 minutes in individual treatment. Aerobic activities were conducted for both groups separately. Exercises using water specific therapy, such as Halliwick rotation control and Bad Ragaz ring method, were used in the aquatic group and in the conventional group, physiotherapeutic techniques were applied, approaching the concepts of proprioceptive neuromuscular facilitation (PNF) and decubitus change training. The following tests were used to measure the risk of fall/balance: Timed Up and Go Test, Sit-to-Stand in 30 seconds and Functional Reach. Results: Both physiotherapeutic interventions, aquatic and conventional, showed to be greatly efficient however aquatic physiotherapy showed certain advantages compared to conventional physical therapy, promoting more beneficial effects in the gait speed, balance, motor abilities and, mainly, in the reduction of the risk of fall.Keywords: elderly, Halliwick, Bad Ragaz, Physical therapy, aquatic, risk of fall.

The cognitive effects of modafinil in breast cancer survivors: A randomized clinical trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9004-9004 ◽  
Author(s):  
S. Kohli ◽  
S. G. Fisher ◽  
Y. Tra ◽  
K. Wesnes ◽  
G. R. Morrow
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Phase 1 ◽  
Secondary Memory ◽  
Phase 2 ◽  
Breast Cancer Patients ◽  
Memory And Attention

9004 Background: Patients receiving treatment for cancer can experience a diminution of their cognitive abilities which can persist for many years after. The present study examined the potential of modafinil as a cognitive enhancer on memory and attention in a randomized clinical trial in breast cancer patients following completion of treatment. Methods: Breast cancer patients who reported a score of = 2 on the Brief Fatigue Inventory (BFI) an average of 22.8 months following completion of chemotherapy were enrolled. In Phase 1, patients received 200mg modafinil open-label once daily for 4 weeks. In Phase 2, patients with a positive response following Phase 1 were randomized either to an additional 4 weeks of modafinil or to placebo. Tests of memory and attention selected from the Cognitive Drug Research (CDR) computerized cognitive assessment were performed at baseline (before modafinil) and after completing Phase 1 and 2. The difference between scores at baseline and scores at Phase 1 and Phase 2, were subjected to a Wilcoxon's signed rank test. Results: Of the 82 women enrolled, 68 completed all 3 CDR assessments in the study (range=33–83 years, median age=54 years). At the end of Phase 1 (week 4), modafinil had a significant effect on the Speed of Memory Index (p=0.0047) and the Digit Vigilance Test (p=0.0014) but showed no significant effect on Quality of Working Memory (p=0.3528) nor on Power of Attention (p=0.8953). At the end of phase 2 (week 8), the group that continued modafinil demonstrated improved Mean Continuity of Attention (p=0.0002) compared with the placebo group and also demonstrated significantly greater improvements in Quality of Episodic Secondary Memory relative to placebo (p<0.005). This improvement was observed at week 4, and was maintained throughout the study. Finally, continued modafinil demonstrated significantly greater improvement in Speed of Memory relative to placebo (p=0.009). Conclusions: Modafinil provides significant improvements in attention and speed of memory for breast cancer patients following their treatment of cancer. Although further study is needed, these findings suggest that modafinil may enhance quality of life in this patient population. Supported by a grant from Cephalon, Inc and NCI Grants U10-CA37420 and R25- CA102618. No significant financial relationships to disclose.

scholarly journals Impact of Intermittent Fasting on Lipid Profile–A Quasi-Randomized Clinical Trial

2021 ◽  
Vol 7 ◽  
Author(s):  
Naseer Ahmed ◽  
Javeria Farooq ◽  
Hasan Salman Siddiqi ◽  
Sultan Ayoub Meo ◽  
Bibi Kulsoom ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Waist Circumference ◽  
Lipid Profile ◽  
Randomized Clinical Trial ◽  
Significant Interaction ◽  
Intervention Group ◽  
Interaction Effects ◽  
Control Group ◽  
Intermittent Fasting

Background: Sub-optimal HDL is a prognostic marker of cardiovascular disease. South Asia has a high prevalence of sub-optimal HDL compared to other parts of the world. Intermittent fasting (IF) is a type of energy restriction which may improve serum HDL and other lipids thereby reducing the risk of cardiovascular diseases.Objective: The aim of the study was to evaluate the effect of IF on lipid profile and HDL-cholesterol in a sample of South Asian adults.Methods: A 6-week quasi-experimental (non-randomized) clinical trial was conducted on participants with low HDL (&lt; 40 mg/dl for men and &lt; 50 mg/dl for women). Participants of the control group were recommended not to change their diet. The intervention group was recommended to fast for ~12 h during day time, three times per week for 6 weeks. Pulse rate, blood pressure, body weight, waist circumference, serum lipid profile, and blood glucose levels were measured at baseline and after 6 weeks.Result: A total of 40 participants were enrolled in the study (N = 20 in each group), while 35 (20 control and 15 intervention) completed the trial and were included in data analysis of the study. Body measurements, including body weight, BMI and waist circumference, showed significant interaction effects (p's &lt; 0.001), indicating that there were larger reductions in the IF group than in the control group. Significant interaction effects were also observed for total (p = 0.033), HDL (p = 0.0001), and LDL cholesterol (p = 0.010) with larger improvements in the IF group.Conclusion: This study suggests that intermittent fasting may protect cardiovascular health by improving the lipid profile and raising the sub-optimal HDL. Intermittent fasting may be adopted as a lifestyle intervention for the prevention, management and treatment of cardiovascular disorders.Clinical Trial Registration: NCT03805776, registered on January 16, 2019, https://clinicaltrials.gov/ct2/show/NCT03805776

Long-term effects of the use of a step count-specific smartphone application on physical activity and weight loss: a randomized clinical trial (Preprint)

2021 ◽  
Author(s):  
EIICHI YOSHIMURA ◽  
Eri Tajiri ◽  
Ryota Michiwaki ◽  
Naoyuki Matsumoto ◽  
Yoichi Hatamoto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Weight Loss ◽  
Body Weight ◽  
Standard Deviation ◽  
Randomized Clinical Trial ◽  
Step Count ◽  
Smartphone App ◽  
Control Group ◽  
Intervention Period

BACKGROUND Some studies on weight loss promotion using smartphone applications (smartphone app) including mobile applications have shown a weight loss effect, but not an increase in physical activity, and they have not been rigorously examined for longer periods. OBJECTIVE To assess whether the use of a smartphone app will increase physical activity and reduce body weight. METHODS In this parallel randomized clinical trial, participants recruited between April 2018 and June 2019 were randomized in equal proportions to a smartphone app group (n=55) or control group (n=54). The intention-to-treat approach was used to analyze the data from December 2019 through November 2021.　Before the intervention, an hour-long lecture on weight loss instruction and increasing physical activity was conducted once for both groups. Participants in both groups were instructed to weigh themselves immediately after waking up at least once daily from the start of the intervention. Monthly e-mails were sent advising the participants on how to lose weight and increase physical activity in order to maintain or increase motivation in both groups. Participants in the smartphone app group were instructed to launch the app at least once a day to check their step count and rank. The primary outcome was daily accelerometer-measured physical activity (step count) and secondary outcomes was body weight. RESULTS The 109 participants had a mean (standard deviation) age of 47 (8) years. At baseline, the mean (standard deviation) daily total steps were 7259 (3256) for the smartphone app and 8243 (2815) for control groups, respectively. After the 32-week intervention period, the step count per wear time was significantly higher in the smartphone app group than in the control group [average difference (95%CI): 65 (30 to 101) vs. -9 (-56 to 39), p=0.042]. The weight loss was -2.2 kg (-3.1%) in the smartphone app group and -2.2 kg (-3.1%) in the control group, with no significant difference between the groups. During the intervention period, the step count per wear time on Saturdays [615 (545 to 684) vs. 554 (483 to 624), p=0.006] and Sundays [623 (553 to 694) vs. 556 (485 to 627), p=0.004] was significantly higher in the smartphone app group than in the control group. CONCLUSIONS In this trial, the smartphone app group showed increased physical activity, especially on weekends. However, this increased physical activity did not lead to weight loss. CLINICALTRIAL UMIN000033397 https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000037956&type=summary&language=J

Development of a Single-Shot Live-Attenuated Chikungunya Vaccine: A Phase 1 Randomized Clinical Trial in Healthy Adults

2019 ◽  
Author(s):  
Nina Wressnigg ◽  
Romana Hochreiter ◽  
Oliver Zoihsl ◽  
Andrea Fritzer ◽  
Nicole Bézay ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Phase 1 ◽  
Healthy Adults ◽  
Single Shot

scholarly journals Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Somayeh Makaremnia ◽  
Marieh Dehghan Manshadi ◽  
Zahra Khademian
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Program ◽  
Randomized Clinical Trial ◽  
Thalassemia Major ◽  
Trial Registration ◽  
Control Group ◽  
Positive Thinking ◽  
Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

scholarly journals Intraoperative protective ventilation in patients undergoing major neurosurgical interventions: a randomized clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Longhini ◽  
Laura Pasin ◽  
Claudia Montagnini ◽  
Petra Konrad ◽  
Andrea Bruni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcome ◽  
Adverse Events ◽  
Respiratory Rate ◽  
Randomized Clinical Trial ◽  
Protective Ventilation ◽  
Adult Patients ◽  
Control Group ◽  
Neurosurgical Procedures ◽  
Neurosurgical Patients

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

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