Physical activity following pulmonary embolism and clinical correlates in selected patients: a cross-sectional study.

Background: There is limited knowledge regarding physical activity and clinical correlates among people who have suffered a pulmonary embolism (PE). Objectives: To assess physical activity levels after PE and potential clinical correlates. Methods: One hundred forty-five individuals free of major comorbidities were recruited at a mean of 23 months (range, 6-72) after PE diagnosis. Physical activity was assessed by steps/day on the Sensewear monitor for 7 consecutive days, exercise capacity with the incremental shuttle walk test, and cardiac function with left ventricular ejection fraction (LVEF). The association between physical activity and other variables was analyzed by a mixed-effects model. Results: Participants achieved a mean of 6494 (SD, 3294; range, 1147-18.486) steps/day. The mixed-effects model showed that physical activity was significantly associated with exercise capacity (ß-coefficient, 0.04; 95% CI, 0.03-0.05) and LVEF (ß-coefficient, -0.81; 95% CI, -1.42 to -0.21). The analysis further showed that men became less physically active with increasing age (ß-coefficient, -0.14; 95% CI, -0.24 to -0.04), whereas no change with age could be detected for women. Conclusion: In selected post-PE patients, physical activity seems to be associated with exercise capacity and LVEF but not with quality of life, dyspnea, or characteristics of the initial PE. Men appear to become less physically active with increasing age.

The Effects of Exercise Training in Patients With Persistent Dyspnea Following Pulmonary Embolism: A Randomized Controlled Trial.

BACKGROUND: Persistent dyspnea, functional limitations, and reduced quality of life (QoL) are common following pulmonary embolism (PE). Rehabilitation is a potential treatment option, but the scientific evidence is limited. RESEARCH QUESTION: Does an exercise-based rehabilitation program improve exercise capacity in PE survivors with persistent dyspnea? STUDY DESIGN AND METHODS: This randomized controlled trial was conducted at two hospitals. Patients with persistent dyspnea following PE diagnosed 6 to 72 months earlier, without cardiopulmonary comorbidities, were randomized 1:1 to either the rehabilitation or the control group. The rehabilitation program consisted of two weekly sessions of physical exercise for 8 weeks and one educational session. The control group received usual care. The primary end point was the difference in Incremental Shuttle Walk Test between groups at follow-up. Secondary end points included differences in the Endurance Shuttle Walk Test (ESWT), QoL (EQ-5D and Pulmonary Embolism-QoL questionnaires) and dyspnea (Shortness of Breath questionnaire). RESULTS: A total of 211 subjects were included: 108 (51%) were randomized to the rehabilitation group and 103 (49%) to the control group. At follow-up, participants allocated to the rehabilitation group performed better on the ISWT compared with the control group (mean difference, 53.0 m; 95% CI, 17.7-88.3; P = .0035). The rehabilitation group reported better scores on the Pulmonary Embolism-QoL questionnaire (mean difference, -4%; 95% CI, -0.09 to 0.00; P = .041) at follow-up, but there were no differences in generic QoL, dyspnea scores, or the ESWT. No adverse events occurred during the intervention. INTERPRETATION: In patients with persistent dyspnea following PE, those who underwent rehabilitation had better exercise capacity at follow-up than those who received usual care. Rehabilitation should be considered in patients with persistent dyspnea following PE. Further research is needed, however, to assess the optimal patient selection, timing, mode, and duration of rehabilitation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT03405480; URL: www. CLINICALTRIALS: gov.

Mental health among patients with chronic musculoskeletal pain and its relation to number of pain sites and pain intensity, a cross-sectional study among primary health care patients.

BACKGROUND: Chronic musculoskeletal pain (CMP) is characterised by pain related to the muscles or the joints with a duration of three months or more and is associated with high symptomatic burden in patients in primary health care. CMP is commonly associated with impaired mental health, which may affect the rehabilitation process. The primary aim of this study was to compare symptoms of anxiety, depression, fatigue, and insomnia in patients in primary health care with and without CMP. The secondary aim was to assess difference in mental health symptoms related to number of pain sites and pain intensity. METHODS: This cross-sectional study was conducted in Trondheim, Norway. All patients aged 21-58 from randomly selected general practitioners (GPs) were invited to participate. Participants were classified into two groups according to presence of CMP. Symptoms of anxiety, depression, fatigue, and insomnia were assessed by the Hospital Anxiety and Depression Scale (HADS), Chalder Fatigue Questionnaire (CFQ), and Insomnia Severity Index (ISI), respectively, using an online survey system. RESULTS: From the patient lists of six GPs, we included 969 patients. Mean age 46 years (SD: 10.1), and 517 reported CMP. CMP patients reported higher mean symptom score for anxiety (5.4 vs 3.7), depression (3.4 vs 2.0), fatigue (14.2 vs 11.2), and insomnia (8.1 vs 4.4), all p < 0.01 compared to no-CMP patients. Symptoms of impaired mental health increased with increasing number of pain sites and pain intensity (p < 0.001). CONCLUSIONS: Primary health care patients with CMP reported significantly more symptoms of anxiety, depression, fatigue, and insomnia than patients without CMP. The higher number of pain sites and pain intensity, the more mental health symptoms, especially of anxiety. Primary health care personnel have to address mental health issues when treating patients with CMP. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02020772, 25/12/2013).

Cross-cultural adaptation and validation of the Norwegian version of the Leicester Cough Questionnaire in chronic obstructive pulmonary disease.

BACKGROUND: Cough is a common symptom among patients with chronic obstructive pulmonary disease (COPD), but there are currently no patient-reported outcome measures (PROM) for subjective cough symptoms in Norwegian. OBJECTIVE: The objective was to translate and validated the most widely used PROM for chronic cough, the Leicester Cough Questionnaire (LCQ) from English to Norwegian (NLCQ) using established guidelines. METHODS: Forward and backward translations were performed using external translators. All phases were discussed in an expert workgroup until consensus was achieved. Ten patients were interviewed about the pre-final version to assess understandability and ease to complete. The final NLCQ was externally proofread and tested for content and construct validity, internal consistency, test-retest reliability and measurement error. RESULTS: Mean (SD) age was 67 (7.9) years, and 62% of the sample were female (n = 56/89). According to GOLD stages, 10% had mild, 27% moderate, 35% severe and 22% very severe COPD, respectively. GOLD stages were missing for five patients (6%). The NLCQ showed acceptable accordance with the original, acceptable understandability and ease to complete, satisfactory content reliability, total score construct validity, internal consistency and test-retest reliability. Test-retest bias was low, but measurement error was larger than previously reported. The standard error of measurement and smallest detectable change were 1.56 and 4.32, respectively. Construct validity and factor analysis raised concerns regarding the three subdomains. CONCLUSION: The present cross-cultural adaptation of the NLCQ showed satisfactory reliability and overall validity. Due to concerns for the validity of the three domains, we suggest use should be restricted to the NLCQ total score until these are reassessed.

Antenatal pelvic floor muscle training and urinary incontinence: a randomized controlled 7-year follow-up study.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence is common postpartum. Our aims were to assess whether antenatal exercise including pelvic floor muscle training (PFMT) has long-term effects on urinary incontinence (UI) and to explore factors associated with UI 7 years postpartum. METHODS: A follow-up of a two-centre randomized controlled trial performed at St. Olavs Hospital and Stavanger University Hospital, Norway. In the original trial women were randomized to a 12-week structured exercise protocol including PFMT or standard antenatal care during pregnancy. Link to an electronic questionnaire was sent by postal mail 7 years postpartum. Prevalence of UI was assessed with Sandvik severity index and compared between groups. Factors associated with UI were studied using multivariable logistic regression analysis. RESULTS: The response rate was 35% (298/855). UI was reported by 78 (51%) in the intervention group and 63 (57%) in the control group (p = 0.539). In the multivariable logistic regression analyses, women with UI at inclusion had a five-fold increase in odds of UI at 7 years (OR 5.4, 95% CI 2.6, 11.5). Engaging in regular exercise was not significantly associated with UI at 7 years; however, UI was associated with lower exercise intensity (OR 2.4, 95% CI 1.2, 4.6). CONCLUSIONS: We found no group differences of antenatal exercise including PFMT on UI after 7 years among the responders. UI in pregnancy increased the risk of long-term UI. Regular exercise was not associated with UI at 7 years; however, women with UI were more than twice as likely to exercise at lower intensity than continent women.

Treatment of urinary incontinence in women with chronic obstructive pulmonary disease-a randomised controlled study.

BACKGROUND: Little is known regarding treatment of urinary incontinence (UI) in women with chronic obstructive pulmonary disease (COPD). The aim of the study was to explore the efficacy of pelvic floor muscle training (PFMT) or cough-suppression techniques (CST) on UI in women with COPD. METHODS: A three-armed, two-centred, single-blinded, randomised controlled study was performed. Subjects were randomised to (a) PFMT for 16 weeks, (b) 2-3 educational sessions in CST, or (c) written information only. All participants completed questionnaires about UI, cough symptoms, and health status and underwent clinical examinations to evaluate the strength of the pelvic floor muscles and exercise capacity. Daily physical activity levels were measured using an activity monitor and lung function with spirometry. With a significance level of 5% and an 80% chance of detecting a significant difference between groups of 2.5 points on the ICIQ UI SF score, our sample size calculation showed that a total of 78 women, 26 in each group, was required to complete the study. RESULTS: During the period 2016 to 2018, 95 women were invited to the study. A total of 42 were recruited, three were excluded and 10 (24%) dropped out during the follow-up period. Mean ICIQ-UI SF total baseline score was 9.6 (range: 1-17) and 7.0 (range: 0-16) at follow-up. Changes in subjective UI as measured with the ICIQ-UI SF questionnaire were seen in the PFMT group and control group, but not in the CST group. CONCLUSION: Due to the low number of available participants and recruitment difficulties including practical issues such as travel distance, lack of interest, poor state of health, and high number of comorbidities, our results are inconclusive. However, reduced subjective UI was observed in the PFMT and control groups with a trend towards best effect in the PFMT group. Screening for UI is advisable in all women with COPD to be able to identify and treat these women to reduce symptom burden and improve quality of life. Future studies should focus on barriers to recruitment as well as randomised controlled studies with larger sample sizes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02614105. 25th November 2015.

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial.

BACKGROUND: Recently, a large group of patients with persistent dyspnea, poor physical capacity, and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name "post pulmonary embolism syndrome" (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea, and HRQoL in PPS patients. METHODS: A two-center randomized controlled trial (RCT) is being performed at Østfold Hospital and Akershus University Hospital in Norway. Patients with PPS are 1:1 randomized into an intervention or a control group. The intervention consists of a supervised, outpatient rehabilitation program twice weekly (1 h) for 8 weeks provided by experienced physiotherapists. The intervention involves individually adapted exercises based on existing pulmonary rehabilitation programs (relaxation, interval, and resistance training), and an educational session including topics such as normal anatomy and physiology of the respiratory and circulatory system, information on PE/PPS, breathing strategies, and benefits of exercise/physical activity. Patients randomized to the control group receive usual care without specific instructions to exercise. Participants in the intervention and control groups will be compared based on assessments conducted at baseline, 12 weeks, and 36 weeks after inclusion using the incremental shuttle walk test (primary outcome) and endurance shuttle walk test (exercise capacity), Sensewear activity monitor (daily physical activity), the modified Medical Research Council scale, the Shortness of Breath Questionnaire (dyspnea), and EQ-5D-5L and the Pulmonary Embolism Quality of Life Questionnaire (HRQoL). Recruitment of 190 patients is currently ongoing. DISCUSSION: Results from this study may provide a currently untreated group of PPS patients with an effective treatment resulting in reduced symptoms of dyspnea, improved exercise capacity, and better HRQoL following PE. TRIAL REGISTRATION: Clinical Trials NCT03405480 . Registered prospectively on September 2017. Protocol version 1 (from original protocol September 2017). The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1).

What factors are associated with health-related quality of life among patients with chronic musculoskeletal pain? A cross-sectional study in primary health care.

BACKGROUND: Chronic musculoskeletal pain (CMP) affects daily life function and is the most prevalent disorder in primary health care. The primary objective was to examine demographic factors and pain characteristics associated with reduced health-related quality of life (HRQoL) among patients in primary care reporting CMP. Our secondary objective was to compare HRQoL in patients with and without CMP. METHOD: This cross-sectional study was conducted in Trondheim, Norway. Twenty randomly selected GPs, and their listed patients aged 21-58 were invited to participate. Self-reported CMP data was collected using online questionnaires. HRQoL was measured by the 15D questionnaire, total score of 0.9 was used as cut-off for clinical reduced HRQoL. RESULTS: A total of 969 patients (650 females) were recruited from six GPs' patient lists, mean age 45.6 (SD 10.1). CMP was reported by 517 (53%). Factors significantly associated with reduced HRQoL were gender (OR 2.0, 95% CI 1.2, 3.4), disability pension (OR 26.6, 95% CI 3.1, 228.0), mood (OR 1.3, 95% CI 1.1, 1.6), relations with other people (OR 0.8, 95% CI 0.6, 0.9), sleep (OR 1.2, 95% CI 1.0, 1.3) and enjoyment (OR 1.2, 95% CI 1.0). CMP patients had significantly lower total HRQoL score compared to patients without CMP (Between group difference 0.08, 95% CI 0.07-0.09). Half of the CMP patients reported a HRQoL score < 0.9 compared to 14% in the no CMP group. CONCLUSIONS: Being female, receiving disability pension, and several psychosocial factors were found highly associated with reduced HRQoL in CMP patients, whereas pain characteristics were not. Patients with CMP reported statistically and clinically significant lower HRQoL than patients without CMP. Due to low response rate the conclusions must be handled with caution. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02020772).

Strong agreement between interview-obtained and self-administered Wexner and St. Mark's scores using a single questionnaire.

INTRODUCTION AND HYPOTHESIS: St Mark's incontinence score (SMIS) and the Wexner score have been constructed and validated as interview-based scoring systems. We developed a single questionnaire from which a separate SMIS or Wexner score could be derived. This study aimed to demonstrate the level of agreement between self-administered (sSMIS and sWexner) and interview-based (iSMIS and iWexner) scores using this questionnaire. METHODS: One hundred five consecutive patients (30 male) seen in the incontinence outpatient clinics at the Østfold Hospital Trust, Sarpsborg, and University Hospital of North Norway, Tromsø, completed the self-administered incontinence questionnaire prior to the appointment. Following clinical investigation, the patients were interviewed about their symptoms according to the SMIS and Wexner scores, with the interviewers blinded to the results from self-reported questionnaire. Agreement between total scores and between subscores of the various items were determined using interclass correlation coefficient (ICC) and kappa statistics, respectively. RESULTS: The self-administered questionnaire was incomplete in six cases (5.7%) and the interview-based was incomplete in two cases. Agreement was almost perfect between the iSMIS and sSMIS and between the iWexner score and sWexner score (ICC 0.90 and 0.92, respectively). Agreement was substantial to almost perfect for all items in both scoring systems, with kappa values ranging from 0.64-0.94. Mean iSMIS was 9.48 versus 9.53 for sSMIS (p = 0.90) and 8.26 versus 8.44 for the iWexner and sWexner score, respectively (p = 0.42). CONCLUSION: The SMIS and Wexner scores can be completed by the patients using a single questionnaire, and the derived SMIS and Wexner scores are highly consistent with scores obtained by interview.

Anal incontinence after vaginal delivery or cesarean section.

INTRODUCTION: Uncertainties remain as to whether a cesarean section is protective for the short-term and long-term development of anal incontinence. Our aim was to explore whether women who had delivered only vaginally were at greater risk of anal incontinence than nulliparous women and women who had undergone cesarean sections only. MATERIAL AND METHODS: Background information, medical history, and data on anal incontinence (defined as fecal or flatus incontinence weekly or more) reported by women participating in a large population-based health survey in Norway (the Nord-Trøndelag Health Study 3) during the period October 2006 to June 2008 were collected and linked to data from the Medical Birth Registry of Norway. The prevalence of anal incontinence was calculated and multivariate logistic regression analyses were applied. RESULTS: The mean age of the 12 567 women was 49.9 years. The age and educational level of women who had cesarean sections only were similar to those who had a vaginal delivery and obstetric anal sphincter injuries (OASIS). Nulliparous women and those who had a vaginal delivery and no OASIS were older and had higher educational achievements than women who had delivered by cesarean section exclusively, and women with OASIS. One in four women with OASIS reported anal incontinence compared with one in six of the other women (P < .001). Age, educational level, diarrhea, constipation, birthweight, and OASIS increased the risk of anal incontinence in all women. Parity was associated with anal incontinence in parous women only. No differences were found for fecal urgency. CONCLUSIONS: Women with vaginal deliveries complicated by OASIS are at increased risk of anal incontinence. However, no increased risk of anal incontinence was found in nulliparous women or women who had cesarean sections only or vaginal deliveries not complicated by OASIS.

Prevalence and predictors of double incontinence 1 year after first delivery.

INTRODUCTION AND HYPOTHESIS: Urinary (UI) and anal incontinence (AI) are common pelvic floor disorders (PFD), and postpartum women experiencing double incontinence (DI), the combination of UI and AI, tend to have more severe symptoms and a greater impact on quality of life. Our objective was to investigate the prevalence and predictors of postpartum DI and UI alone 1 year after first delivery. METHODS: In this prospective cohort study, 976 women reported the prevalence of DI and UI alone 1 year after their first delivery in one of two hospitals in Norway using the St Marks score and the ICI-Q UI SF. RESULTS: DI was significantly reduced from 13% in late pregnancy to 8% 1 year later, whereas 30% reported UI at both time points. Incontinence in late pregnancy predicted incontinence 1 year after delivery. Higher age was associated with UI alone. Compared with caesarean delivery, normal vaginal or instrumental delivery increased the risk of UI alone more than three and four times respectively. Obstetric anal sphincter injuries showed a four-fold increase in the risk of DI. CONCLUSIONS: Nearly 50% reported incontinence symptoms 1 year after first delivery. Continence status during pregnancy was one of the main predictors of postpartum continence status. Mode of delivery increased the risk of postpartum UI, whereas obstetric anal sphincter injuries increased the risk of postpartum DI.

Interview-based versus self-reported anal incontinence using St Mark's incontinence score.

INTRODUCTION AND HYPOTHESIS: St Mark's incontinence score (SMIS) was originally designed and validated for use in an interview setting (iSMIS), and there is conflicting evidence for the validity of the self-administered SMIS (sSMIS). Our objective was to compare self-administered and interview-based reports of anal incontinence (AI) symptoms. METHODS: A total of 147 women reported symptoms of AI on a sSMIS before inclusion in a clinical study investigating the effect of conservative treatment for AI 1 year after delivery. After clinical investigations, an iSMIS was completed by one of two consultant surgeons blinded to the sSMIS results. The correlation and agreement among the individual items of the iSMIS and the sSMIS were assessed using Spearman's rho and weighted kappa statistics, respectively. RESULTS: The mean iSMIS and sSMIS reported was 4.0 (SD: 3.6) and 4.3 (SD: 4.0), respectively. Spearman's rho showed a strong relationship between the two total SMIS scores (r = 0.769, n = 147, p < 0.001), and explained variance was 59% (r2=0.591). Except for the individual item about gas incontinence, women reported more frequent AI symptoms on the sSMIS than on the iSMIS. The assessment of consistency among the individual items of the iSMIS and sSMIS showed substantial agreement (κ ≥ 0.60) for all items except for fair agreement for the item about formed stool incontinence (κ = 0.22), and moderate for the item about any change in lifestyle (κ = 0.5). CONCLUSIONS: The level of consistency between the two methods of reporting anal incontinence symptoms suggests that the St Mark's score may be used as both an interview-based and a self-administered incontinence score.

Anal incontinence among first time mothers - what happens in pregnancy and the first year after delivery?

INTRODUCTION: Pregnancy- and delivery-related factors affect postpartum anal incontinence. We aimed to explore changes in continence status among primiparas from late pregnancy through the first year postpartum. MATERIAL AND METHODS: In this prospective cohort study set in two Norwegian hospitals, 862 healthy primiparas completed questionnaires about the main outcome measure anal incontinence, including flatus incontinence and urgency, at three time points; late pregnancy, 6 and 12 months postpartum. Socioeconomic and delivery-related data were obtained from hospital records. Logistic regression analyses were applied to determine the association between continence status at 12 months postpartum, and continence status in late pregnancy, 6 months postpartum, demographic and delivery-related characteristics. RESULTS: Among the 189 (22%) primiparas reporting anal incontinence in late pregnancy, 34 (18%) had persistent anal incontinence 1 year later. Forty-eight (43%) of the 113 women incontinent at 6 months postpartum experienced persistent anal incontinence at 12 months. Eight percent of previously continent women reported new onset anal incontinence at 6 and 12 months after delivery. Occipitoposterior presentation was the only delivery-related factor increasing the risk of postpartum anal incontinence [odds ratio (OR) 1.8, 95% confidence interval (CI) 1.0-3.4]. Young age increased the risk of anal incontinence at 1 year after delivery, whereas incontinence in late pregnancy increased the risk of anal incontinence persisting through 6 and 12 months postpartum. CONCLUSION: In most first-time mothers with postpartum anal incontinence, the onset of anal incontinence was before delivery. Except for occipitoposterior presentation, no delivery-related factors increased the risk of postpartum anal incontinence. This may indicate that hormonal, mechanical or neuromuscular changes in pregnancy affect long-term anal incontinence more than vaginal delivery.