No benefit of vorapaxar on walking performance in patients with intermittent claudication

2021 ◽  
pp. 1358863X2110420
Author(s):  
Shirling Tsai ◽  
Yulun Liu ◽  
Mohamad Amer Alaiti ◽  
Jorge Antonio Gutierrez ◽  
Emmanouil S Brilakis ◽  
...  

Background: The effect of pharmacologic agents in improving walking and quality of life measures in patients with intermittent claudication (IC) is variable. The objective of this study was to investigate the effect of the novel antithrombotic vorapaxar on symptom status in patients with IC. Methods: The study was a multicenter, randomized, placebo-controlled trial wherein patients with IC were treated with either vorapaxar or placebo in addition to a home exercise program for 6 months. Walking performance and quality of life were assessed by graded treadmill test (GTT) and 12-Item Short-Form Survey (SF-12), respectively, at baseline and at 6 months. A total of 102 subjects were randomized across 12 centers. Results: Of the subjects randomized, 66 completed all study assessments and comprised the dataset that was analyzed. After 6 months, there was no significant difference between the vorapaxar and placebo groups in walking performance, as reflected by the GTT, or in quality of life, as reflected by the SF-12. There were no severe bleeding events in either group. Conclusion: This study found no benefit of vorapaxar in patients with IC and reiterates the need for future drug therapy studies that expand the benefits of supervised exercise therapy in patients with IC. ClinicalTrials.gov Identifier: NCT02660866

2021 ◽  
Author(s):  
Simge Temizkan ◽  
Miray BUDAK

Abstract Purpose: The purpose of this study was to investigate the effects of KT and AE on pain, attitude, depression, and quality of life in women with dysmenorrhoea. Methods: Forty-five women with dysmenorrhoea were randomly divided into three groups as KT group(n=15), AE group(n=15) and control group(n=15). In KT Group, 6 sessions of KT were applied, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended. In the AE group, walking and climbing stairs were given during the menstrual cycle, 3 days a week, 45 minutes. No application was made to the control group. All groups were evaluated with Beck Depression Scale(BDS), Mcgill Pain Questionnaire(MPQ), Menstrual Attitude Scale(MAS), and Short Form-36(SF-36) before and after treatment. Results: A significant difference was found in MAS and SF-36 mental and physical in the KT group(p<0.05). There was a significant decrease in the MPQ in the AE group(p<0.05). No significant result was found in the control group. There were significant differences in MPQ and MAS Time*Group interaction(p<0.05). There was no significant difference between the KT and AE Group in post-hoc tests(p<0.05). Conclusion: In conclusion, KT and AE may decrease pain and improve attitude and quality of life in women with dysmenorrhoea. “retrospectively registered” Trial registration number (NCT04856280), date of registration (20.04.2021).


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1944.2-1944
Author(s):  
S. Y. Cetin ◽  
B. Basakci Calik ◽  
A. Ayan

Background:Systemic sclerosis (SSc) is an autoimmune disease that not only affects the skin but also causes symptoms that involve important internal organs such as joints, muscles, and heart and lungs. Due to all these multiple system involvements, the quality of life of individuals with scleroderma decreases. Tai Chi Chuan is a combination of physical exercise and relaxation techniques, and it is a traditional Chinese exercise method used to improve mental and physical health of people. There are many studies showing that Tai Chi improves the body’s aerobic capacity and psychological well-being. In the literature, Tai Chi has been shown to reduce pain, improve physical function, improve healing effects on depression and quality of life, especially, in the elderly, individuals with musculoskeletal diseases such as rheumatoid arthritis and osteoarthritis, and improve cardiac vascular risk factors such as hypertension and diabetes.Objectives:The aim of the study is to examine the effectiveness of Tai Chi on cardiopulmonary functions and quality of life in patients with SSc.Methods:28 SSc patients (25 females, 3 males) with an average age of 53.00 ± 10.00 were included in the study. For training, patients were divided into two groups by block randomization method. Group 1 received 60 minutes of Tai Chi exercise program and Group 2 received 60 minutes of home exercise for 2 days a week for 8 weeks. 6-min walk test (6MWT) and St. George Respiratory Questionnaire was used to evaluate the cardiopulmonary functions, Short form 36 (SF-36) was used to evaluate the quality of life. All evaluations were performed at baseline and at the end of the 8th weekResults:When the groups were compared before training, there was no significant difference (p> 0.05). In post-training comparisons, there was a significant difference in all parameters in Tai Chi group (p: 0.001-0.045); there was a significant difference in the physical function sub-parameter of SF-36 and 6MWT in the home exercise group (p: 0.045, p: 0.038, respectively). Comparing the post-training groups, Tai Chi group was found to be superior in terms of all parameters compared to the home exercise group (p: 0.00-0.04). No side effects were observed during the exercises.Conclusion:As a result of our study; Tai Chi has a possitive effect on cardiopulmonery function and quality of life in patients with SS. Tai Chi should be included in rehabilitation programs as a safe alternative type of exercise to improve cardiopulmonery function and quality of life in patients with SSc.References:[1]de Oliveira NC, Portes LA, Pettersson H, Alexanderson H, Boström C. Aerobic and resistance exercise in systemic sclerosis: State of the art. Musculoskeletal Care. 2017;15:316–323.[2]Jia X, Jiang C, Tao J, Li Y, Zhou Y, Chen LD. Effects of core strength training combined with Tai Chi Chuan for the musculoskeletal system and cardiopulmonary function in older adults: A study protocol for a randomized controlled trial. Medicine (Baltimore). 2018;97(35):e12024.[3]Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, McAlindon T. Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum. 2009; 61:1545–1553.[4]Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford) 2005; 44:685–687.Disclosure of Interests:None declared


2010 ◽  
Vol 38 (05) ◽  
pp. 849-859 ◽  
Author(s):  
Mei-Yuan Sun ◽  
Ching-Liang Hsieh ◽  
Yung-Yen Cheng ◽  
Hung-Chang Hung ◽  
Tsai-Chung Li ◽  
...  

Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Joan M ODonnell ◽  
Maurizio Manuguerra ◽  
Jemma L Hodge ◽  
Greg Savage ◽  
Michael K Morgan

Background: Studies have questioned the effectiveness of surgery for the management of unruptured intracranial aneurysm (uIA). Few studies have examined the ability to drive and quality of life (QOL) after surgery for uIA. Objective: This study examined the effectiveness of surgical management of uIA by measuring patients’ perceived quality of life and their cognitive abilities related to driving. Methods: Between January 2011 and January 2016 patients with a uIA were assessed using the Quality Metric Short Form 36 (SF36) and the off-road driver screening instrument DriveSafeDriveAware. Reassessments were conducted at the 6-week post-operative follow-up for surgical patients and at 12-month follow-up for surgical and conservatively managed patients. Results: 175 patients enrolled in the study, of which 112(66%) had surgical management of their aneurysm. For the surgical cases who completed all assessments (N=74), there was a trend for the DriveSafe pre-operative mean score of 108 (SD 10.7) to be lower than the 6-week and 12-month post-operative mean scores (111 SD 9.7 and 112 SD 10.2 respectively)(p=0.05). There were no significant changes in DriveAware scores at any epoch or between patient groups nor in the MCS in the surgical group.. There was a significant decline in PCS scores at 6 weeks post-operatively which recovered at 12 months (52 SD 8.1, 46 SD 6.8 and 52 SD 7.1 respectively)( p <0.01). There was no significant difference in 12-month mRS scores between the surgical cases who completed with cases who did not complete all assessments. Conclusion: Surgery for uIA did not affect cognitive abilities for driving at 6 weeks or 12 months after surgery. There was a decline in the QOL in the first months after surgery, however QOL returned to pre-surgical status 12 months after surgery. If the risk of seizures is low and there are no post-operative complications, returning to driving can be recommended.


2021 ◽  
Author(s):  
Richa Sharma ◽  
Robert Drummond ◽  
William Wiltshire ◽  
Robert Schroth ◽  
Milos Lekic ◽  
...  

ABSTRACT Objectives To investigate adolescent orthodontic patient experiences and quality of life with fixed appliances compared to Invisalign. Materials and Methods Adolescent patients in active treatment with Invisalign or fixed appliances for a minimum of 6 months were provided with the Child Oral Health Impact Profile-Short Form 19 questionnaire, along with additional items of interest that were assessed separately. Pearson's χ2 test was used to compare responses (P &lt; .05), and unpaired t-tests (P &lt; .05) were used to test for differences in mean satisfaction, quality of life, and domain scores. Results In total, 74 patients (37 in each treatment group) participated. Overall, no significant differences were noted in the mean quality of life, satisfaction, or domain scores between the two groups. A significant difference was noted in the time taken to adjust to appliances, with the Invisalign group demonstrating faster adaptation. Additionally, the fixed appliance group was 3.8 times more likely to report missing school because of their appliance (95% confidence interval [CI]: 1.2, 12.5) and 2.7 times more likely to report having difficulty eating certain foods (95% CI: 1.1, 7.1). When the sample of females between the ages of 14 and 18 was analyzed, the Invisalign group reported feeling attractive more often than the fixed appliance group. Conclusions Both treatment groups were generally very satisfied with their treatment modality. The overall quality of life of adolescent orthodontic patients undergoing treatment with fixed appliances and Invisalign for a minimum of 6 months was similar.


2021 ◽  
Author(s):  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
Dorthe Overgaard

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.


Author(s):  
Susan Matthews ◽  
Martin Fox ◽  
Sarah Coy ◽  
Jane Whittaker ◽  
Gail Brough ◽  
...  

Background/Aims Peripheral arterial disease is common among those aged 60 years or above and can cause debilitating intermittent claudication. This impacts quality of life and is a marker for increased morbidity and mortality, mainly from cardiovascular disease. Access to recommended exercise programmes for people with symptomatic peripheral arterial disease is poor in most areas of the UK. This study aimed to evaluate the benefits of expanding an established cardiac rehabilitation service to accommodate supervised exercise for people with peripheral arterial disease Methods The study evaluated 11 participants peripheral arterial disease and intermittent claudication who were referred by the Manchester leg circulation service. Participants underwent the programme involving eight weekly 1.5 hour sessions of supervised exercise and cardiovascular education with support, reassurance and motivation. The participants' blood pressure, walking impairment, quality of life, anxiety and depression were monitored and reviewed. Results Overall, the participants' walking distance, intermittent claudication, quality of life and blood pressure had improved. The participants' overall satisfaction with the programme was excellent. The programme also demonstrated clinical and cost-effectiveness. Conclusions A structured, supervised exercise programme can have considerable benefits for people with peripheral arterial disease, improving their symptoms and quality of life. It may also help to reduce the morbidity and mortality risks associated with inactivity in this patient group.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  

Abstract Background Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5. Trial registration Chinese Clinical Trial Registry ChiCTR1900025469. Registered on 27 August 2019.


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