P.2.023 A multi-center, one year, haloperidol controlled trial assessing the long term safety, efficacy and quality of life of sertindole in stable schizophrenic patients

1997 ◽  
Vol 7 ◽  
pp. S201-S202 ◽  
Author(s):  
S. Foley ◽  
P. Wozniak ◽  
C. Silber ◽  
R. Mack
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Schizophrenic Patients ◽  
One Year

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

2021 ◽  
Author(s):  
Florie FILLOL ◽  
Ludivine PARIS ◽  
Sébastien PASCAL ◽  
Aurélien MULLIEZ ◽  
Christian-François ROQUES ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Waist Circumference ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

scholarly journals Impact of adherence to long-term oxygen therapy on patients with COPD and exertional hypoxemia followed for one year

2018 ◽  
Vol 44 (5) ◽  
pp. 390-397 ◽  
Author(s):  
Carolina Bonfanti Mesquita ◽  
Caroline Knaut ◽  
Laura Miranda de Oliveira Caram ◽  
Renata Ferrari ◽  
Silmeia Garcia Zanati Bazan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Oxygen Therapy ◽  
Severe Hypoxemia ◽  
Bode Index ◽  
One Year ◽  
Long Term Oxygen Therapy ◽  
Minute Walk

ABSTRACT Objective: To determine the impact of adherence to long-term oxygen therapy (LTOT) on quality of life, dyspnea, and exercise capacity in patients with COPD and exertional hypoxemia followed for one year. Methods: Patients experiencing severe hypoxemia during a six-minute walk test (6MWT) performed while breathing room air but not at rest were included in the study. At baseline and after one year of follow-up, all patients were assessed for comorbidities, body composition, SpO2, and dyspnea, as well as for anxiety and depression, having also undergone spirometry, arterial blood gas analysis, and the 6MWT with supplemental oxygen. The Saint George’s Respiratory Questionnaire (SGRQ) was used in order to assess quality of life, and the Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index was calculated. The frequency of exacerbations and the mortality rate were noted. Treatment nonadherence was defined as LTOT use for < 12 h per day or no LTOT use during exercise. Results: A total of 60 patients with COPD and exertional hypoxemia were included in the study. Of those, 10 died and 11 experienced severe hypoxemia during follow-up, 39 patients therefore being included in the final analysis. Of those, only 18 (46.1%) were adherent to LTOT, showing better SGRQ scores, higher SpO2 values, and lower PaCO2 values than did nonadherent patients. In all patients, SaO2, the six-minute walk distance, and the BODE index worsened after one year. There were no differences between the proportions of adherence to LTOT at 3 and 12 months of follow-up. Conclusions: Quality of life appears to be lower in patients with COPD and exertional hypoxemia who do not adhere to LTOT than in those who do. In addition, LTOT appears to have a beneficial effect on COPD symptoms (as assessed by SGRQ scores). (Brazilian Registry of Clinical Trials - ReBEC; identification number RBR-9b4v63 [http://www.ensaiosclinicos.gov.br])

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

scholarly journals One-Year Follow-Up of Spa Treatment in Older Patients with Osteoarthritis: A Prospective, Single Group Study

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Jolanta Zwolińska ◽  
Aneta Weres ◽  
Justyna Wyszyńska
Keyword(s):  
Quality Of Life ◽  
Social Relations ◽  
Mineral Waters ◽  
Spa Therapy ◽  
Spa Treatment ◽  
Short And Long Term ◽  
One Year

Introduction. Few studies evaluated the effects of spa therapy on pain perception and quality of life in older people with osteoarthritis. Therefore, the aim of the study was to evaluate the short- and long-term effects of spa therapy on quality of life and pain in patients aged 60 years and older with osteoarthritis. Materials and Methods. 70 patients with generalized osteoarthritis were enrolled in the study. Spa treatment lasted 3 weeks (15 days of treatment) and was applied during a session lasting 120 to 150 minutes a day. All the patients benefited from kinesiotherapy, physical agent modalities, massage, peloid therapy, hydrotherapy with mineral waters, and crenotherapy. Visual Analogue Scale (VAS) for pain, the Laitinen scale, and WHOQOL-BREF questionnaire were used to assess the condition of the patients. The examinations were performed three times: at the beginning of the spa treatment, after three months, and one year after the first examinations. Results. Statistically significant improvements were observed in pain (VAS) between consecutive assessments (p <.001). Laitinen scale also reported beneficial, statistically significant changes in the level of pain (p <.001). The WHOQOL-BREF questionnaire reported a statistically significant improvement in the domain of social relations in 2-3 and 1-3 periods (p = .025 and p = .011, resp.). A significant improvement was recorded in the domain of environment between 2-3 and 1-3 periods (p <.001). Conclusion. Spa treatment reduced the level of pain in majority of the patients in short- and long-term follow-up and contributed to improving the quality of life in the domain of social relations and environment. To confirm the results of this study, there is a need for a randomized controlled trial comparing spa treatment with usual care in the older population with osteoarthritis. Trial Registration Number. This trial was retrospectively registered on 3 January 2018 with NCT03388801.

Sign in / Sign up

Export Citation Format

Share Document