scholarly journals Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial

Gut ◽  
2021 ◽  
pp. gutjnl-2020-321811
Author(s):  
Rakesh Kalapala ◽  
Arun Karyampudi ◽  
Zaheer Nabi ◽  
Santosh Darisetty ◽  
Nitin Jagtap ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Reflux Disease ◽  
Controlled Trial ◽  
Acid Reflux ◽  
Control Group ◽  
Full Thickness ◽  
Demeester Score ◽  
Novel Device ◽  
Related Quality

BackgroundThe majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD.DesignPatients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months.ResultsSeventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29–42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9–100.0) versus 8.0 (2.2–21.6); p<0.001) and 12 (92.3 (84.4–100.0) versus 9.1 (4.8–36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group.ConclusionEFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate.Trial registration numberNCT03322553.

scholarly journals Decreasing postoperative cognitive deficits after heart surgery: Protocol for a randomized controlled trial on cognitive training

2019 ◽  
Author(s):  
Marius Butz ◽  
Jasmin El-Shazly ◽  
Gebhard Sammer ◽  
Marlene Tschernatsch ◽  
Sabrina Kastaun ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Training ◽  
Cognitive Deficits ◽  
Heart Surgery ◽  
Controlled Trial ◽  
Training Effect ◽  
Control Group ◽  
Related Quality ◽  
Health Related

Abstract Background The occurrence of postoperative cognitive deficits, especially after heart surgery, has been demonstrated in several studies. These deficits can clearly be noticed by the patients as well as by their close relatives in daily life. Furthermore, postoperative cognitive deficits can decrease quality of life in social functioning and earning capacity. The aim of this study is to investigate whether early postoperative cognitive training can reduce subjective and objective postoperative cognitive deficits Methods The proposed study is a multicenter, 2-arm randomized controlled trial involving 144 elderly patients undergoing elective heart valve surgery with extracorporeal circulation. Patients will be assigned to either a training group or a control group. The intervention involves a paper-and-pencil-based cognitive training, which is conducted for 36 minutes over a period of 18 days. The training starts about 1 week after surgery and is carried out during the hospitalized rehabilitation phase. The control group will not receive a cognitive training or a placebo intervention. A detailed assessment of psychological functions and health-related quality of life prior to surgery at discharge from rehabilitation and 3 and 12 months after discharge will be performed. The Primary outcome of this trial is the training effect on objective cognitive functions at discharge from rehabilitation. Secondary outcomes are the training effect on objective and subjective cognitive functions (3 and 12 months after discharge), depression, health-related quality of life, and the impact of perioperative cerebral ischemia on the training effect. Perioperative cerebral ischemia will be measured with postoperative magnetic resonance imaging including diffusion-weighted sequences. Discussion Should it be shown that our cognitive training can improve postoperative cognitive deficits as well as quality of life, one possibility could be to integrate this intervention into early rehabilitation. Furthermore, we hope that the investigation of perioperative ischemia by diffusion-weighted magnetic resonance imaging will improve our understanding of neurobiological factors influencing the course of postoperative cognitive plasticity.

scholarly journals Decreasing postoperative cognitive deficits after heart surgery: protocol for a randomized controlled trial on cognitive training

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Marius Butz ◽  
Jasmin El Shazly ◽  
Gebhard Sammer ◽  
Marlene Tschernatsch ◽  
Sabrina Kastaun ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Training ◽  
Cognitive Deficits ◽  
Heart Surgery ◽  
Controlled Trial ◽  
Training Effect ◽  
Control Group ◽  
Related Quality ◽  
Health Related

Abstract Background The occurrence of postoperative cognitive deficits, especially after heart surgery, has been demonstrated in several studies. These deficits can clearly be noticed by the patients and by their close relatives in daily life. Furthermore, postoperative cognitive deficits can decrease quality of life in social functioning and earning capacity. The aim of this study is to investigate whether early postoperative cognitive training can reduce subjective and objective postoperative cognitive deficits. Methods The proposed study is a multicenter, two-arm, randomized controlled trial involving 144 elderly patients undergoing elective heart-valve surgery with extracorporeal circulation. Patients will be assigned to either a training group or a control group. The intervention involves paper-and-pencil-based cognitive training, which is conducted for 36 min over a period of 18 days. The training starts about 1 week after surgery and is carried out during the hospitalized rehabilitation phase. The control group will not receive cognitive training or a placebo intervention. A detailed assessment of psychological functions and health-related quality of life prior to surgery at discharge from rehabilitation and 3 and 12 months after discharge will be performed. The primary outcome of this trial is the training effect on objective cognitive functions at discharge from rehabilitation. Secondary outcomes are the training effect on objective and subjective cognitive functions (3 and 12 months after discharge), depression, health-related quality of life, and the impact of perioperative cerebral ischemia on the training effect. Perioperative cerebral ischemia will be measured with postoperative magnetic resonance imaging including diffusion-weighted sequences. Discussion Should it be shown that our cognitive training can improve postoperative cognitive deficits and quality of life, one possibility could be to integrate this intervention into early rehabilitation. Furthermore, we hope that the investigation of perioperative ischemia by diffusion-weighted magnetic resonance imaging will improve our understanding of neurobiological factors influencing the course of postoperative cognitive plasticity. Trial registration German Clinical Trials Register (DRKS), DRKS00015512. Retrospectively registered on 21 September 2018.

scholarly journals Decreasing postoperative cognitive deficits after heart surgery: Protocol for a randomized controlled trial on cognitive training

2019 ◽  
Author(s):  
Marius Butz ◽  
Jasmin El-Shazly ◽  
Gebhard Sammer ◽  
Marlene Tschernatsch ◽  
Sabrina Kastaun ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Training ◽  
Cognitive Deficits ◽  
Heart Surgery ◽  
Controlled Trial ◽  
Training Effect ◽  
Control Group ◽  
Related Quality ◽  
Health Related

Abstract Background The occurrence of postoperative cognitive deficits, especially after heart surgery, has been demonstrated in several studies. These deficits can clearly be noticed by the patients as well as by their close relatives in daily life. Furthermore, postoperative cognitive deficits can decrease quality of life in social functioning and earning capacity. The aim of this study is to investigate whether early postoperative cognitive training can reduce subjective and objective postoperative cognitive deficits Methods The proposed study is a multicenter, 2-arm randomized controlled trial involving 144 elderly patients undergoing elective heart valve surgery with extracorporeal circulation. Patients will be assigned to either a training group or a control group. The intervention involves a paper-and-pencil-based cognitive training, which is conducted for 36 minutes over a period of 18 days. The training starts about 1 week after surgery and is carried out during the hospitalized rehabilitation phase. The control group will not receive a cognitive training or a placebo intervention. A detailed assessment of psychological functions and health-related quality of life prior to surgery at discharge from rehabilitation and 3 and 12 months after discharge will be performed. The Primary outcome of this trial is the training effect on objective cognitive functions at discharge from rehabilitation. Secondary outcomes are the training effect on objective and subjective cognitive functions (3 and 12 months after discharge), depression, health-related quality of life, and the impact of perioperative cerebral ischemia on the training effect. Perioperative cerebral ischemia will be measured with postoperative magnetic resonance imaging including diffusion-weighted sequences. Discussion Should it be shown that our cognitive training can improve postoperative cognitive deficits as well as quality of life, one possibility could be to integrate this intervention into early rehabilitation. Furthermore, we hope that the investigation of perioperative ischemia by diffusion-weighted magnetic resonance imaging will improve our understanding of neurobiological factors influencing the course of postoperative cognitive plasticity.

scholarly journals Improvements in health-related quality of life and function in middle-aged women with chronic diseases of lifestyle after participating in a non-pharmacological intervention programme: A pragmatic randomised controlled trial

2019 ◽  
Vol 8 ◽  
Author(s):  
Roline Y. Barnes ◽  
Jennifer Jelsma ◽  
Romy Parker
Keyword(s):  
Quality Of Life ◽  
Chronic Diseases ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled

Background: Musculoskeletal diseases consume a large amount of health and social resources and are a major cause of disability in both low- and high-income countries. In addition, patients frequently present with co-morbid chronic diseases of lifestyle. The area of musculoskeletal disease is restricted by a lack of epidemiological knowledge, particularly in low- and middle-income countries.Objectives: This pragmatic randomised controlled trial assessed the benefits of a 6-week physiotherapy intervention for middle-aged women with musculoskeletal conditions compared to usual care.Method: A weekly 2-h educational programme utilising a workbook, discussion group and exercise class was presented for the intervention group, while the control group received usual care. The primary outcome was health-related quality of life. Parametric and non-parametric data were used to determine the equivalence between the groups.Results: Twenty-two participants were randomised to the intervention and 20 to the control group. The control group demonstrated no within-group improvement in health-related quality of life items, compared to significant improvements in two items in the intervention group. The change in median utility score within the intervention group was twice as large as the change in the control group. With regard to self-efficacy, the intervention group demonstrated significant within-group changes in perceived management of fatigue and discomfort.Conclusion: The positive impact of the intervention on the participants suggests that the programme should continue at the clinic in question, but should be presented at a more convenient time for participants who work, as recruitment to the study was less than anticipated. Primary health care systems in South Africa urgently need to put structures in place for effective management of the functional impact of chronic diseases of lifestyle and musculoskeletal conditions. It is time for physiotherapists and possibly other health care professionals to participate in the development of appropriate community level interventions to address the functioning and quality of life of individuals living with the diseases.

Measuring the Effects of an Animal-Assisted Intervention for Pediatric Oncology Patients and Their Parents: A Multisite Randomized Controlled Trial

2017 ◽  
Vol 35 (3) ◽  
pp. 159-177 ◽  
Author(s):  
Amy McCullough ◽  
Ashleigh Ruehrdanz ◽  
Molly A. Jenkins ◽  
Mary Jo Gilmer ◽  
Janice Olson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Group Randomized Trial ◽  
Related Quality ◽  
Treatment Measures ◽  
Animal Assisted Intervention

Objective: This multicenter, parallel-group, randomized trial examined the effects of an animal-assisted intervention on the stress, anxiety, and health-related quality of life for children diagnosed with cancer and their parents. Method: Newly diagnosed patients, aged 3 to 17 years (n = 106), were randomized to receive either standard care plus regular visits from a therapy dog (intervention group), or standard care only (control group). Data were collected at set points over 4 months of the child’s treatment. Measures included the State-Trait Anxiety Inventory™, Pediatric Quality of Life Inventory, Pediatric Inventory for Parents, and child blood pressure and heart rate. All instruments were completed by the child and/or his/her parent(s). Results: Children in both groups experienced a significant reduction in state anxiety ( P < .001). Parents in the intervention group showed significantly decreased parenting stress ( P = .008), with no changes in stress among parents in the control group. However, no significant differences between groups over time on any measures were observed. Conclusions: Animal-assisted interventions may provide certain benefits for parents and families during the initial stages of pediatric cancer treatment.

scholarly journals The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial

2020 ◽  
Vol 34 (8) ◽  
pp. 1056-1071
Author(s):  
Line Kildal Bragstad ◽  
Ellen Gabrielsen Hjelle ◽  
Manuela Zucknick ◽  
Unni Sveen ◽  
Bente Thommessen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Post Stroke ◽  
Related Quality ◽  
Health Related ◽  
The Mean

Objective: To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. Design: Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. Setting: Community. Subjects: Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group ( n = 166) or control group ( n = 156). Interventions: The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1–1½ hour sessions delivered during the first six months post-stroke. Main measures: The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. Results: The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: −0.74, 95% confidence interval (CI): −3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. Conclusion: The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.

Acupuncture in Patients With Headache

Cephalalgia ◽  
2008 ◽  
Vol 28 (9) ◽  
pp. 969-979 ◽  
Author(s):  
S Jena ◽  
CM Witt ◽  
B Brinkhaus ◽  
K Wegscheider ◽  
SN Willich
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Treatment Success ◽  
Primary Headache ◽  
Routine Care ◽  
Acupuncture Group ◽  
Control Group ◽  
Related Quality ◽  
Health Related

We aimed to investigate the effectiveness of acupuncture in addition to routine care in patients with primary headache (> 12 months, two or more headaches/month) compared with treatment with routine care alone and whether the effects of acupuncture differ in randomized and non-randomized patients. In a randomized controlled trial plus non-randomized cohort, patients with headache were allocated to receive up to 15 acupuncture sessions over 3 months or to a control group receiving no acupuncture during the first 3 months. Patients who did not consent to randomization received acupuncture treatment immediately. All subjects were allowed usual medical care in addition to study treatment. Number of days with headache, intensity of pain and health-related quality of life (SF-36) were assessed at baseline, and after 3 and 6 months using standardized questionnaires. Of 15 056 headache patients (mean age 44.1 ± 12.8 years, 77% female), 1613 were randomized to acupuncture and 1569 to control, and 11 874 included in the non-randomized acupuncture group. At 3 months, the number of days with headache decreased from 8.4 ± 7.2 (estimated mean ± S.E.) to 4.7 ± 5.6 in the acupuncture group and from 8.1 ± 6.8 to 7.5 ± 6.3 in the control group ( P < 0.001). Similarly, intensity of pain and quality of life improvements were more pronounced in the acupuncture vs. control group ( P < 0.001). Treatment success was maintained through 6 months. The outcome changes in non-randomized patients were similar to those in randomized patients. Acupuncture plus routine care in patients with headache was associated with marked clinical improvements compared with routine care alone.

scholarly journals Effects of Baduanjin Exercise on Cognitive Function and Cancer-related Symptoms in Women With Breast Cancer Receiving Chemotherapy: a Randomized Controlled Trial

2021 ◽  
Author(s):  
Xiaolin Wei ◽  
Ruzhen Yuan ◽  
Juan Yang ◽  
Wei Zheng ◽  
Yongmei Jin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Health Related Quality ◽  
Breast Cancer Patients ◽  
Related Quality ◽  
Health Related

Abstract Purpose Cognitive decline is one of the main side effects of breast cancer patients after relevant treatment, but there is a lack of clear measures for prevention and management without definite mechanism. Moreover, postoperative patients also have a need for limb rehabilitation. Whether the cognitive benefits of Baduanjin exercise can improve the overall well-being of this breast cancer patients remains unknown. This study aims to figure out these problems in the under-researched Chinese population.Methods This randomized controlled trial was conducted on 70 patients with breast cancer undergoing chemotherapy who were randomly assigned and allocated to (1:1) the supervised Baduanjin group (5 times/week, 30 min each time) or the control group for three months. The effects of Baduanjin exercise intervention were evaluated by outcome measures including subjective cognitive function, symptoms (fatigue, depression and anxiety) and health-related quality of life at pre-intervention (T0), 4 weeks (T1), 8 weeks (T2) and 12 weeks (T3). The collected data were analyzed by using an intention-to-treat principle and linear mixed-effects modeling.Results Participants in the Baduanjin group had a significantly greater improvement in terms of FACT-cog (F=14.511; P < 0.001), PCI (F=15.915; P < 0.001), PCA (F=2.767; P= 0.047), and health-related quality of life (F=8.900; p = 0.004) compared with the control group over the time. The exercise-cognition relationship was significantly mediated by reduced fatigue (indirect effect: β= 0.132; 95% CI: 0.046, 0.237) and improved anxiety (indirect effect: β=-0.075; 95% CI: -0.165, -0.004).Conclusions This pilot study revealed the benefits and outlined the underlying mediating mechanism of Baduanjin exercise to the subjective cognition and health-related quality of life of Chinese breast cancer patients receiving chemotherapy. The findings provided insights into the development of public health initiatives to promote brain health and improve quality of life among breast cancer patients.Trial registration number ChiCTR 2000033152

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