A study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgia

Abstract Background This study aims to analyze the effects of a potentially anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory markers, and quality of life of fibromyalgia (FM) patients. Methods A sample of 100 female patients diagnosed with FM, followed up at Portuguese Institute of Rheumatology (IPR) in Lisbon, is being randomly allocated in two groups. Patients in the intervention group are adopting an anti-inflammatory diet, characterized by the exemption of the intake of foods containing gluten, dairy, sugar, and ultra-processed foods, during 3 months. During the first month, a low fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) diet is implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months. Patients in the control group are adopting a diet based on general recommendations for healthy eating. The outcomes are pain, fatigue, quality of sleep, quality of life, gastrointestinal symptoms, and inflammation. Before and after the 3 months intervention, and also 1 month after beginning the intervention, the following questionnaires are applied: Revised Fibromyalgia Impact Questionnaire, visual analog pain scale, Brief Pain Inventory,visual analog scale from a list of common gastrointestinal and extraintestinal symptoms in FM, Short Form 36, Fatigue Severity Survey, and Pittsburg Sleep Quality Index. Ultra-sensitive serum C-reactive protein, eritrocyte sedimentation rate, and interleukin-8 are determined. Age, physical activity, anthropometric parameters, and body composition are being collected. Student’s t test will assess the association between the disease evaluation parameters, the inflammatory markers, and the dietary interventions. Discussion The results of this study are expected to determine whether a change in patient nutrition helps to alleviate symptoms, which would optimize medical intervention. Trial registration www.ClinicalTrials.gov NCT04007705. Registered on July 5, 2019.

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Impact of sleep disturbances and autonomic dysfunction on the quality of life of patients with fibromyalgia

Journal of Basic and Clinical Physiology and Pharmacology ◽

10.1515/jbcpp-2020-0007 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Ruchi Singh ◽

Nirendra Kumar Rai ◽

Aakarsh Rastogi ◽

Chiranjeevi Endukuru ◽

Ankur Joshi ◽

...

Keyword(s):

Quality Of Life ◽

Sleep Quality ◽

Autonomic Dysfunction ◽

Sleep Disturbances ◽

Short Form ◽

Fibromyalgia Impact Questionnaire ◽

Poor Sleep ◽

Poor Sleep Quality ◽

Full Spectrum

Abstract Objectives Fibromyalgia, a painful musculoskeletal disorder is associated with sleep disturbances as well as autonomic dysfunction. Pathophysiology of fibromyalgia is yet not clear and neuroanatomical proximity of sleep and autonomic centre prompts probable involvement of the two impacting the quality of life of fibromyalgia patients. Present study was done with the objective to explore the extent of sleep disturbances and/or autonomic dysfunction in fibromyalgia and asses their impact on quality of life of fibromyalgia patients. Method and materials Thirty consecutive fibromyalgia patients (diagnosed by ACR 2010) from out-patient department and 30 age-gender matched controls were enrolled after the ethical clearance. All participants were evaluated for: (1) sleep using Pittsburgh sleep quality index and medical outcomes study sleep scale-12 Revised, (2) Quality of life by 36 item short-form health survey-36v2TM and revised fibromyalgia impact questionnaire (only patients). Autonomic functions of patients were evaluated by standard cardiovascular autonomic function tests by Ewing’s battery and heart rate variability (5-min) measurement. Results Fibromyalgia patients had increased sleep disturbances compared to controls (39.46 ± 11, 59.61 ± 2.31; p=0.0001) and very poor sleep quality (13.63 ± 4.15, 3.03 ± 1.56; p=0.0001) as well as quality of life (p=0.0001) which further deteriorated with increasing severity of fibromyalgia. Twelve patients had autonomic dysfunction but it was neither associated with sleep disturbances nor with quality of life. Conclusions Mild to moderate grade fibromyalgia patients have significant sleep disturbance, poor sleep quality which remarkably impacts their quality of life. Autonomic dysfunction is not an early feature of disease. The study suggests that full spectrum of sleep disturbances and sleep quality should be explored in fibromyalgia syndrome (FMS) patients.

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Pilates and dance to patients with breast cancer undergoing treatment: study protocol for a randomized clinical trial – MoveMama study

Trials ◽

10.1186/s13063-019-3874-6 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Leonessa Boing ◽

Tatiana do Bem Fretta ◽

Melissa de Carvalho Souza Vieira ◽

Gustavo Soares Pereira ◽

Jéssica Moratelli ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Physical Activity ◽

Body Image ◽

Side Effects ◽

Sleep Quality ◽

Control Group ◽

Belly Dance ◽

Belly Dancing

Abstract Background Breast cancer is a global public health issue. The side effects of the clinical treatment can decrease the quality of life of these women. Therefore, a healthy lifestyle is essential to minimize the physical and psychological side effects of treatment. Physical activity has several benefits for women with breast cancer, and Pilates solo and belly dancing can be an enjoyable type of physical activity for women with breast cancer undergoing clinical treatment. The purpose of this study is to provide a Pilates solo and a belly dance protocol (three times per week/16 weeks) for women undergoing breast cancer treatment and compare its effectiveness with that in the control group. Methods The participants will be allocated to either the intervention arm (Pilates solo or belly dance classes three times per week for 16 weeks) or a control group (receipt of a booklet on physical activity for patients with breast cancer and maintenance of habitual physical activity routine). The Pilates solo and belly dance classes will be divided into three stages: warmup and stretching, the main stage, and relaxation. Measurements of the study outcomes will take place at baseline; postintervention; and 6, 12, and 24 months after the end of the intervention (maintenance period). The data collection for both groups will occur with a paper questionnaire and tests covering general and clinical information. The primary outcome will be quality of life (EORT QLQ-C30 and EORT QLQ-BR23), and secondary outcomes will be physical aspects such as cardiorespiratory fitness (6-min walk test and cycle ergometer), lymphedema (sum of arm circumference), physical activity (IPAQ short version), disabilities of the arm (DASH), range of motion (goniometer test), muscular strength (dynamometer test) and flexibility (sit and reach test), and psychological aspects such as depressive symptoms (Beck Depression Inventory), body image (Body Image After Breast Cancer Questionnaire), self-esteem (Rosenberg), fatigue (FACT-F), pain (VAS), sexual function (FSFI), and sleep quality (Pittsburgh Sleep Quality Index). Discussion In view of the high prevalence of breast cancer among women, the implementation of a specific protocol of Pilates solo and belly dancing for patients with breast cancer is important, considering the necessity to improve their physical and psychological quality of life. Pilates solo and belly dancing are two types of physical activity that involve mental and physical concentration, music, upper limb movements, femininity, and social involvement. An intervention with these two physical activities could offer options of supportive care to women with breast cancer undergoing treatment, with the aim being to improve physical and psychological quality of life. Trial registration ClinicalTrials.gov, NCT03194997. Registration date 12 August 2017. Universal Trial Number (World Health Organization), U1111-1195-1623.

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Observational non-randomised controlled evaluation of the effectiveness of cancer counselling centres: a study protocol

BMJ Open ◽

10.1136/bmjopen-2019-032889 ◽

2019 ◽

Vol 9 (12) ◽

pp. e032889

Author(s):

Solveigh Paola Lingens ◽

Georgia Schilling ◽

Julia Harms ◽

Holger Schulz ◽

Christiane Bleich

Keyword(s):

Quality Of Life ◽

Short Form ◽

Control Group ◽

Life Questionnaire ◽

Psychosocial Variables ◽

European Organization ◽

Psychological Burden ◽

Patients With Cancer ◽

Small Effect Size

IntroductionIn recent years, medical treatment for cancer has improved, thereby increasing the life expectancy of patients with cancer. Hence, the focus in healthcare shifted towards analysing treatments that offer to decrease distress and improve the quality of life of patients with cancer. The psychological burden of patients with cancer originates from all kinds of psychosocial challenges related to diagnosis and treatment. Cancer counselling centres (CCounCs) try to address these concerns. However, the current literature lacks research on the effectiveness of CCounCs. This study aims to assess the effectiveness of CCounCs with regard to distress and other relevant psychosocial variables (quality of life, anxietyand so on).Methods and analysisThis prospective observational study with a non-randomised control group has three measurement points: before the first counselling session (baseline, t0) and at 2 weeks and 3 months after baseline (t1, t2). Patients and their relatives who seek counselling between December 2018 and November 2020 and have sufficient German language skills will be included. The control group will be recruited at clinics and oncological outpatient centres in Hamburg. Propensity scoring will be applied to adjust for differences between the control and intervention groups at baseline. Sociodemographic data, medical data and counselling concerns are measured at baseline. Distress (distress thermometer), quality of life (Short Form-8 Health Survey, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30), anxiety (Generalized AnxietyDisorder-7), depression (Patient HealthQuestionnaire-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants, differences between the intervention and control groups of a small effect size (f=0.10) can be detected with a power of 80%.Ethics and disseminationThe study was registered prior to data collection with the German Registration of Clinical Trials in September 2018. Ethical approval was received by the local psychological ethical committee of the Center for Psychosocial Medicine at the University Medical Centre Hamburg-Eppendorf in August 2018. The results will be published in peer-reviewed journals.Trial registration numberDRKS00015516; Pre-results.

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Quality of life in patients with Charcot-Marie-Tooth disease type 1A

Arquivos de Neuro-Psiquiatria ◽

10.1590/0004-282x20130045 ◽

2013 ◽

Vol 71 (6) ◽

pp. 392-396 ◽

Cited By ~ 2

Author(s):

Juliana B. Taniguchi ◽

Valeria M.C. Elui ◽

Flavia L. Osorio ◽

Jaime E.C. Hallak ◽

Jose A.S. Crippa ◽

...

Keyword(s):

Quality Of Life ◽

Short Form ◽

Control Group ◽

Life Questionnaire ◽

Charcot Marie Tooth ◽

Social And Emotional ◽

Charcot Marie Tooth Disease ◽

Sf 36 ◽

And Gender

We assessed the functional impairment in Charcot-Marie-Tooth resulting from 17p11.2-p12 duplication (CMT1A) patients using the Short-Form Health Survey (SF-36), which is a quality of life questionnaire. Twenty-five patients of both genders aged ≥10 years with a positive molecular diagnosis of CMT1A were selected. Age- and gender-matched Control Group (without family history of neuropathy), and the sociodemographic and professional conditions similar to the patients' group were selected to compare the SF-36 results between them. The results showed that the majority quality of life impairments in CMT1A patients occurred in the social and emotional domains. Functional capacity also tended to be significantly affected; other indicators of physical impairment were preserved. In conclusion, social and emotional aspects are mostly neglected in the assistance provided to CMT1A Brazilian patients, and they should be better understood in order to offer global health assistance with adequate quality of life as a result.

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Satisfaction with Quality of Life in Patients with Minimum Cicatricial Damage of the Face and Neck

Clinical Psychology and Special Education ◽

10.17759/cpse.2018070106 ◽

2018 ◽

Vol 7 (1) ◽

pp. 75-90 ◽

Cited By ~ 3

Author(s):

A. Iaremenko ◽

E. Isaeva ◽

T. Kolegova ◽

E. Sitkina ◽

Yu. Vasilieva

Keyword(s):

Quality Of Life ◽

Physical Condition ◽

Traditional Method ◽

Comparison Group ◽

Short Form ◽

Life Quality ◽

Control Group ◽

Surgical Methods ◽

The Face

Satisfaction with quality of life and self-attitude in patients operated by «traditional» (conventional surgical methods) and endoscopically assisted methods are considered in the article. Differences in the quality of life in patients, self-attitude to ones appearance are described. 65 patients were surgically operated and examined. Control group – patients operated by «traditional» techniques (35 patients), the average age of patients was 38 ± 11,1 years. The comparison group – patients operated using endoscopically assisted methods (30 patients), the average age of patients was 44 ± 17,7 years. Psychodiagnostic methods: 1. N. E. Vodopyanova`s scale of life quality; 2. The Short Form-36; 3. S.R. Panteleev`s Assessment of self-relationship. Complaints of paresthesia and pain experienced by patients who underwent a “traditional” operation were revealed as a result of the examination. Operated on with an endoscopically assisted method patients did not present any complaints. Differences between the assessment of the life quality and self-relationship in examined groups were found. Operated on with an endoscopically assisted method patients evaluated life quality, satisfaction with their appearance and physical condition higher than patients operated on with a “traditional” method.

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Prevalence, Correlations, and Impact of Sleep Disturbance in Chinese Meningioma Patients

10.21203/rs.3.rs-407966/v1 ◽

2021 ◽

Author(s):

Dandan Zhang ◽

Jing Wang ◽

Xixi Gu ◽

Zhifeng Gu ◽

Liren Li ◽

...

Keyword(s):

Quality Of Life ◽

Logistic Regression ◽

Sleep Quality ◽

Sleep Disturbance ◽

Short Form ◽

Binary Logistic Regression ◽

Anxiety And Depression ◽

Newly Diagnosed ◽

Chi Square Analysis

Abstract Purpose Sleep disturbance is common in meningioma patients and may lead to disease aggravation and decreases health-related quality of life (HRQoL). However, the sleep quality of meningioma patients newly diagnosed and ready for surgery has not been well clarified in China. This study aims to evaluate the prevalence, correlates, and impact of sleep disturbance among Chinese meningioma patients. Methods In this cross-sectional study, meningioma patients were recruited from the Affiliated Hospital of Nantong University from January 2020 to November 2020. A series of questionnaires were applied: the 0–10 Numerical Rating Scale (NRS), the Hospital Anxiety and Depression Scale (HADS), the Multidimensional Fatigue Inventory (MFI-20), the Epworth Sleepiness Scale (ESS), the Short-Form 36 (SF-36), the Pittsburgh Sleep Quality Index (PSQI). Independent samples t test, Mann-Whitney U test, chi-square analysis, Pearson/Spearman correlation, and binary logistic regression were used to analyze the data. Results 100 meningioma patients completed the questionnaires. Sleep disturbance affected 43% of the meningioma patients and was linked to many concomitant symptoms, such as headache, fatigue, anxiety and depression. Binary logistic regression indicated that fatigue and headache were predictors of sleep disturbance in meningioma patients. Meanwhile, severe sleep disturbance led to lower quality of life. Conclusions These findings demonstrated that a considerable number of meningioma patients newly diagnosed and ready for surgery suffered from sleep disturbance, potentially contributing to impair HRQoL. Medical personnel should pay more attention to meningioma patients with sleep disturbance and take effective measures to improve sleep quality, with the ultimate goal to improve their HRQoL.

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New Model for Couple Therapy for Patients with Chronic Pain and their Caregivers: An Attempt to Improve Quality of Life and Reduce Pain

Clinical Practice and Epidemiology in Mental Health ◽

10.2174/1745017902016010053 ◽

2020 ◽

Vol 16 (1) ◽

pp. 53-58

Author(s):

Shima Rouhi ◽

Payman Dadkhah ◽

Manijeh Firoozi ◽

Masoud Hashemi

Keyword(s):

Quality Of Life ◽

Chronic Pain ◽

Interpersonal Relationships ◽

Couple Therapy ◽

Short Form ◽

Control Group ◽

Improve Quality ◽

Innovative Therapy ◽

Quasi Experimental

Background: Several psychological interventions have been implemented to manage chronic pain. In this study, in addition to the patients, his/her spouses have participated in the program. Besides, this innovative therapy integrates several practical approaches into one comprehensive protocol. Objective: This study aimed to analyze the effectiveness of couple therapy (patient/caregiver-oriented) on improving the quality of life and reducing pain among patients with chronic pain. Methods: The present study is a quasi-experimental and clinical trial with a control group with pretest and posttest. The authors conducted this study at LABAFINEJAD Hospital in Tehran on 30 patients with chronic pain and their spouses by having a short form of a questionnaire for quality of life and chronic pain score questionnaire to measure the effectiveness of the treatment. Results: The results indicated that this treatment increased two aspects of quality of life remarkably, social function and strength for continuing the performance; that help boosts interpersonal relationships as well. Regarding the results, although the couple-based treatment could improve all aspects of pain, the two primary subscales, physical health and mental health, both enhanced. Besides, the treatment reduced the intensity of pain. Conclusion: Couple-based intervention through increasing social support, improving the quality of sex, decentralizing of pain, and paying attention to the neglected needs of caregivers and patients with chronic pain can improve quality of life and reduce pain in patients.

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Quality of Sleep and Quality of Life during Pregnancy

Journal of the Korean Neurological Association ◽

10.17340/jkna.2020.3.4 ◽

2020 ◽

Vol 38 (3) ◽

pp. 188-193

Author(s):

Keun Tae Kim ◽

Hyoeun Bae ◽

Jin Gon Bae ◽

Yong Won Cho

Keyword(s):

Sleep Quality ◽

Pregnant Women ◽

Short Form ◽

Life Quality ◽

Control Group ◽

Quality Of Sleep ◽

Third Trimester ◽

Cross Sectional ◽

Sf 36

Background: The prevalence of sleep disorders increases as pregnancy progresses, which affects the health of pregnant women, fetal health, and the outcomes of pregnancy. The aim of this study is to evaluate the quality of sleep and life in pregnant women in Korea.Methods: This study is a prospective cross-sectional, case-control study of pregnant women and age-matched controls. From July to September 2019, all participants completed Korean-language versions of the sleep questionnaires including Pittsburgh sleep quality index (K-PSQI), Insomnia severity index, Epworth sleepiness scale, Back’s depression inventory-2(K-BDI), STOP (Snoring, Tiredness, Observed apneas, and high blood Pressure), and short-form 36 (K-SF-36).Results: A total of 422 participants consisted of 385 pregnant women and 137 controls. Second and third trimester were 200 and 185, respectively. K-PSQI scores were higher in pregnant women compared with the controls (7.87±3.49 and 8.50±3.55 vs. 5.79±2.76, <i>p</i><0.001). Total score of K-SF-36 was lowest in third trimester (62.07±17.72) and highest in the control group(79.41±13.36). There was no statistical difference between groups in K-BDI.Conclusions: This study demonstrated worsening of sleep quality as well as life quality during pregnancy. More attention to sleep of pregnant women is needed.

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Relationship between Sleep Disorders and Health Related Quality of Life—Results from the Georgia SOMNUS Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph15081588 ◽

2018 ◽

Vol 15 (8) ◽

pp. 1588 ◽

Cited By ~ 10

Author(s):

Nato Darchia ◽

Nikoloz Oniani ◽

Irine Sakhelashvili ◽

Mariam Supatashvili ◽

Tamar Basishvili ◽

...

Keyword(s):

Quality Of Life ◽

Sleep Quality ◽

Sleep Disorders ◽

Developing World ◽

Short Form ◽

Health Related Quality ◽

Related Quality ◽

Health Related ◽

Insomnia Severity

The extent to which sleep disorders are associated with impairment of health-related quality of life (HRQoL) is poorly described in the developing world. We investigated the prevalence and severity of various sleep disorders and their associations with HRQoL in an urban Georgian population. 395 volunteers (20–60 years) completed Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, STOP-Bang questionnaire, Insomnia Severity Index, Beck Depression Inventory-Short Form, and Short Form Health Survey (SF-12). Socio-demographic data and body mass index (BMI) were obtained. The prevalence of sleep disorders and their association with HRQoL was considerable. All SF-12 components and physical and mental component summaries (PCS, MCS) were significantly lower in poor sleepers, subjects with daytime sleepiness, apnea risk, or insomnia. Insomnia and apnea severity were also associated with lower scores on most SF-12 dimensions. The effect of insomnia severity was more pronounced on MCS, while apnea severity—on PCS. Hierarchical analyses showed that after controlling for potential confounding factors (demographics, depression, BMI), sleep quality significantly increased model’s predictive power with an R2 change (ΔR2) by 3.5% for PCS (adjusted R2 = 0.27) and by 2.9% for MCS (adjusted R2 = 0.48); for the other SF-12 components ΔR2 ranged between 1.4% and 4.6%. ESS, STOP-Bang, ISI scores, all exerted clear effects on PCS and MCS in an individual regression models. Our results confirm and extend the findings of studies from Western societies and strongly support the importance of sleep for HRQoL. Elaboration of intervention programs designed to strengthen sleep-related health care and thereof HRQoL is especially important in the developing world.

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Abstract 452: Effect of Exercise Training on Sleep Quality and Quality of Life in Post Myocardial Infarction Patients

Circulation Research ◽

10.1161/res.119.suppl_1.452 ◽

2016 ◽

Vol 119 (suppl_1) ◽

Author(s):

Jayati Vohra ◽

Kushal Madan ◽

Manish Sharma ◽

J.P.S Sawhney

Keyword(s):

Quality Of Life ◽

Myocardial Infarction ◽

Exercise Training ◽

Sleep Quality ◽

Physical Functioning ◽

Exercise Program ◽

Exercise Group ◽

Control Group ◽

Experimental Group

Objectives: To study the effect of four weeks of aerobic exercise training, on sleep quality and quality of life parameters like anxiety, depression and physical functioning in Post Myocardial Infarction (MI) patients. Methods: ST elevated MI patients (n=21, <65years age) were voluntarily divided into 2 groups, control group (n=11) and exercising group (n=10). The patients in experimental group followed an exercise program of 3 sessions per week for 4 weeks. The subjective quality of life, anxiety and depression levels were assessed by the SF 36 questionnaire and Hospital Anxiety & Depression Scale (HAD scale) and the sleep quality was assessed using Pittsburgh Sleep Quality Index (PSQI). Poor sleep quality and short sleep duration was defined as PSQI > 5 and total sleep time <6hrs. respectively. After 4 weeks of the program the questionnaires were repeated for all 21 patients. Wilcoxon rank order test and Student T test were used. P<0.05 was considered statistically significant Results: Intergroup analysis showed statically significant reduction in anxiety score (9vs0.5) and depression score (3vs0) in exercise group as compared to control group respectively. As compared to control group, exercise group also showed statistically significant improvement in the quality of life parameter score [physical functioning (750vs1000), role functioning physical (0vs400) & emotional (0vs300), energy level (215vs400), emotional well-being (400vs500), social functioning (120vs200), general health (230vs462.5) & health changes (50vs100)]. Intra group analysis also showed significant changes only in exercise group. After 4 weeks of exercise training, PSQI score improved in the experimental group from 9.5±4.11 to 1.13±0.35 (p=0.00029) indicating better sleep quality and duration. While it remained comparable to the baseline values in the control group i.e. from 9.9±4.70 to 10.33±3.87 (p value= 0.514). Conclusion: Four weeks of exercise program improves the quality & duration of sleep and quality of life in MI patients after 2 weeks of index event.

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