Physiotherapy programme reduces fatigue in patients with advanced cancer receiving palliative care: randomized controlled trial.
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ABSTRACT:
SUBMITTER: Pyszora A
PROVIDER: S-EPMC5527074 | biostudies-other | 2017 Sep
REPOSITORIES: biostudies-other
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Project description:ObjectiveFatigue is among the most common symptoms of the long-term effects of coronavirus (long COVID). This study aims to compare the effectiveness of osteopathic manipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PT alone on fatigue and functional limitations after two months post randomization in adults with long COVID.MethodsThis is a study protocol for a two-arm, assessor-blinded, pragmatic randomized controlled superiority trial. Seventy-six participants will be randomly allocated to OMT + PT or PT. The PT includes usual care interventions including motor and respiratory exercises targeting cardiorespiratory and skeletal muscle functions. The OMT entails direct and indirect musculoskeletal, viceral and cranial techniques. Patients will be evaluated before and after a 2-month intervention program, and at 3-month follow-up session. Primary objectives comprise fatigue and functional limitations at 2-month post randomization as assessed by the fatigue severity scale and the Post-COVID Functional State scale. Secondary objectives comprise fatigue and functional limitations at 3 months, and the perceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).RegistrationThis protocol was registered (NCT05012826) and received ethical approval (38342520.7.0000.5235). Participant recruitment began in August 2021 and is expected to conclude in July 2023. Publication of the results is anticipated in 2023.
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Project description:The Heart to Heart Card Game improves psychological health outcomes in hospitalized patients with advanced cancer, but effectiveness studies for patients at home are rare. This randomized controlled study was conducted to determine the effectiveness of the Heart to Heart Card Game on patients with advanced cancer receiving home-based palliative care. Sixty-six participants were randomly assigned to the intervention group (n = 34) and control group (n = 32). The quality of life, dignity, and psychological distress were considered as outcomes, which were assessed pre-intervention and six weeks after the intervention. There was a statistical difference in the quality of life (global health statues) between the intervention group and the control group after intervention (z = 2.017, p < 0.05). A significant difference was found in the quality of life (emotional, social function), dignity (symptom distress dimension), and psychological distress in the intervention group through intragroup comparison before and after the intervention. This randomized trial showed that the Heart to Heart Card Game likely alleviates barriers to end-of-life conversations and helps patients with advanced cancer maintain a more stable mental state. This trial has been registered at the Chinese Clinical Trial Registry (registration number: ChiCTR2100049933).
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Project description:ObjectiveFibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM.MethodsParticipants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks.ResultsAfter 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS.ConclusionAmong women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real-world setting to establish the clinical importance of these findings.
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Project description:BackgroundStudies of the efficacy of vitamin C treatment for fatigue have yielded inconsistent results. One of the reasons for this inconsistency could be the difference in delivery routes. Therefore, we planned a clinical trial with intravenous vitamin C administration.MethodsWe evaluated the effect of intravenous vitamin C on fatigue in office workers. A group of 141 healthy volunteers, aged 20 to 49 years participated in this randomized, double-blind, controlled clinical trial. The trial group received 10 grams of vitamin C with normal saline intravenously, while the placebo group received normal saline only. Since vitamin C is a well-known antioxidant, oxidative stress was measured. Fatigue score, oxidative stress, and plasma vitamin C levels were measured before intervention, and again two hours and one day after intervention. Adverse events were monitored.ResultsThe fatigue scores measured at two hours after intervention and one day after intervention were significantly different between the two groups (p = 0.004); fatigue scores decreased in the vitamin C group after two hours and remained lower for one day. Trial also led to higher plasma vitamin C levels and lower oxidative stress compared to the placebo group (p < 0.001, p < 0.001, respectively). When data analysis was refined by dividing each group into high-baseline and low-baseline subgroups, it was observed that fatigue was reduced in the lower baseline vitamin C level group after two hours and after one day (p = 0.004). The same did not hold for the higher baseline group (p = 0.206).ConclusionThus, intravenous vitamin C reduced fatigue at two hours, and the effect persisted for one day. There were no significant differences in adverse events between two groups. High dose intravenous vitamin C proved to be safe and effective against fatigue in this study.Trial registrationThe clinical trial registration of this trial is http://ClinicalTrials.govNCT00633581.
| S-EPMC3273429 | biostudies-literature
Project description:BACKGROUND:For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. METHODS/DESIGN:This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. DISCUSSION:This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. TRIAL REGISTRATION:Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).
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Project description:ObjectivesThis study aimed to show that ingesting egg white hydrolyzate (EWH) could improve antioxidant capacity and reduce mental fatigue. Two clinical trials were conducted to examine the antioxidant capacity and the fatigue reduction function of EWH. In Study 1, 19 athlete students were received a single dose of EWH (5 g/day) or placebo. In Study 2, 74 athlete students ingested EWH (5 g/day) or placebo before training for 2 weeks.ResultsSingle dose of EWH significantly increased the antioxidant ability compared with the placebo group (p < 0.05), and there was no significant difference between the groups in the oxidative stress test results on Study 1. Two-week intake of EWH significantly decreased mental fatigue compared with the placebo (p < 0.05). This study showed that ingesting EWH improved antioxidant capacity with a single dose and reduced mental fatigue after 2 weeks of ingestion. Trial Registration Japan Medical Association Center for Clinical Trials identifier; JMA-IIA00395 (Study1) and JMA-IIA00396 (Study2), both trials were retrospectively registered on 26 October, 2018.
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Project description:AimTo pilot test a home end-of-life and palliative care intervention for family caregivers and patients with rare advanced lung diseases and to estimate effect-size for the power analysis in a future clinical trial.DesignThis study uses a parallel randomized control trial. Families are randomly assigned to the intervention group or the control group in a 1:1 fashion.MethodsThe study population includes patients with rare advanced lung diseases and their family caregivers who are involved in patients' home care. The control group receives standard care through their hospital or outpatient clinics. The intervention group receives standard care plus 2-weekly home end-of-life and palliative care coaching by experienced community nurses. Primary outcome is breathlessness measured by shortness of breath scale. Secondary outcomes are: (a) caregivers' anxiety and depression measures; (b) the presence of patient's signed advance directives in the medical record or not; and (c) Helpfulness of intervention measured by self-report Helpfulness scale. The study was funded in October 2018 and received ethical Institutional Review Board approval in February 2019.DiscussionWest Virginia has one of the highest incidence rates of lung disease deaths in the nation. However, there is inadequate home end-of-life and palliative care for this underserved population. This is an initial interventional study of nurse-led coaching home-based palliative care for rare advanced lung diseases in rural Appalachia. Developing research collaboration with clinicians is essential for enrolment. Enrolment was successful due to regular meetings with pulmonologists who screened patients per the study inclusion criteria in their specialty clinic and made direct referrals to the research assistants. Results of this study will be used in the future trial.ImpactThe findings will contribute to the evidence-based home nursing care, planning for family/patient preferences and supportive end-of-life palliative care for managing advanced lung diseases at home.Trial registrationClinicalTrials.gov identifier NCT03813667; registered January 23, 2019. https://clinicaltrials.gov/ct2/show/NCT03813667.
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Project description:BackgroundTeam-based and timely integrated palliative care is a gold standard of care in oncology, but issues concerning its optimal organization remain. Palliative Care in Day-Hospital (PCDH) could be one of the most efficient service model of palliative care to deliver interdisciplinary and multidimensional care addressing the complex supportive care needs of patients with advanced cancer. We hypothesize that, compared to conventional outpatient palliative care, PCDH allows the clinical benefits of palliative care to be enhanced.Methods/designThis study is a multicentre parallel group trial with stratified randomization. Patient management in PCDH will be compared to conventional outpatient palliative care. The inclusion criteria are advanced cancer patients referred to a palliative care team with an estimated life expectancy of more than 2 months and less than 1 year. The primary endpoint is health-related quality of life with deterioration-free survival based on the EORTC QLQ-C30 questionnaire. The secondary objectives are the following: increase in patient satisfaction with care using the EORTC PATSAT-C33 and OUT-PATSAT7 questionnaires, better understanding of the prognosis using the PTPQ questionnaire and advance care planning; decrease in the need for supportive care among relatives using the SCNS-P&C-F questionnaire, and reduction in end-of-life care aggressiveness. Patients will complete one to five questionnaires on a tablet before each monthly visit over 6 months and will be followed for 1 year. A qualitative study will take place, aiming to understand the specificity of palliative care management in PCDH. Cost-effectiveness, cost-utility and, an additional economic evaluation based on capability approach will be conducted from a societal point of view.DiscussionThe first strength of this study is that it combines the main relevant outcomes assessing integrated palliative care; patient quality of life and satisfaction; discussion of the prognosis and advance care planning, family well-being and end-of-life care aggressiveness. The second strength of the study is that it is a mixed-method study associating a qualitative analysis of the specificity of PCDH organization, with a medical-economic study to analyse the cost of care.Trial registrationName of the registry: IDRCB 2019-A03116-51 Trial registration number: NCT04604873 Date of registration: October 27, 2020 URL of trial registry record.
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Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:BackgroundMany people constantly use their smartphones in all kinds of situations. Often smartphones are used in a meaningful and targeted way, but frequently they are used as a pastime without any purpose. This also applies to patients and therapists in treatment situations.ObjectiveThe aim of this study was to investigate how purposeful smartphone use compared with recreational smartphone use (by a physiotherapist or by a patient) influenced the perception of a physiotherapeutic treatment situation. We examined the impact of smartphone use during a physiotherapy session on the perception of the physiotherapist, evaluation of attentiveness, and evaluation of smartphone use in physiotherapy in general.MethodsMembers of various music and sports clubs were invited to participate in an online randomized controlled trial. Participants were randomly assigned to one of four conditions. They watched a video in which a physiotherapeutic treatment was shown and in which a smartphone was used or not used in the following four different ways: (1) therapeutically purposeful use, (2) recreational use by the physiotherapist (looking at the phone from time to time with no therapeutic purpose), (3) recreational use by the patient, and (4) no smartphone use (control condition). After watching the video, the participants indicated their perception of the physiotherapist's professional competence, social competence, and empathetic behavior. They also rated the physiotherapist's and patient's attentiveness and evaluated the usage of smartphones generally in physiotherapy.ResultsThe analysis included 118 participants (63 women and 55 men). When the physiotherapist used the smartphone in a purposeful way, the physiotherapist was perceived as more professionally competent (P=.007), socially competent (P=.03), and empathetic (P=.04) than if the physiotherapist used it with no therapeutic purpose. These effects occurred because recreational smartphone use by the physiotherapist was evaluated more negatively than the behavior in the control condition (professional competence: P=.001; social competence: P=.03; empathy: P=.04). Moreover, when the physiotherapist used the smartphone in a recreational way, the physiotherapist was perceived as being less attentive (P<.001). Likewise, when the patient used the smartphone in a recreational way, the patient was perceived as being less attentive (P<.001). Finally, smartphone use in physiotherapy was rated as more positive in general when the smartphone was used in a purposeful way compared with the conditions in which the physiotherapist or patient looked at the smartphone with no therapeutic purpose (P<.001). This positive evaluation occurred because purposeful use led to a more positive rating than no smartphone use (P<.001, R=0.42).ConclusionsSmartphones are only appropriate for therapists and patients if they are used directly for a therapeutic purpose. Otherwise, it is better not to use smartphones during treatment.Trial registrationAsPredicted (aspredicted.org) #24740; https://aspredicted.org/blind.php?x=vv532i.
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