Associations between health-related quality of life, physical function and pain in older women with osteoporosis and vertebral fracture.
ABSTRACT: BACKGROUND:Osteoporosis and vertebral fractures represent a major health burden worldwide, and the prevalence of osteoporosis is expected to increase as the world's population ages. Suffering from vertebral fracture has a substantial impact on the individual's health-related quality of life (HRQoL), physical function and pain. Complex health challenges experienced by older people with osteoporosis and vertebral fractures call for identification of factors that may influence HRQoL, as some of these factors may be modifiable. The objective is to examine the independent associations between HRQoL, physical function and pain in older women with osteoporosis and vertebral fracture. METHODS:This study has a cross-sectional design, using data from 149 home-dwelling Norwegian women with osteoporosis and vertebral fracture, aged 65+. Data on HRQoL (Short Form 36 (SF-36), Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)), physical function (walking speed, balance and strength), pain, as well as sociodemographic information were collected. Simple linear regression analyses were conducted and multivariable regression models were fitted to investigate the associations. RESULTS:Lower levels of HRQoL were significantly associated with lower levels of physical function, measured by walking speed, and higher levels of pain. Pain was significantly associated with all of the subscales in SF-36, with the exception of Mental Health and Mental Component Score, and all the subscales of QUALEFFO-41. Walking speed was significantly associated with 5 of 8 subscales of SF-36 (except Bodily Pain, Vitality, Mental Health and Mental Component Score), and with 4 of 6 subscales of QUALEFFO-41 (except Score Pain and Mood). CONCLUSION:This study shows that pain and walking speed were, independently of one another, associated with HRQoL in older women with osteoporosis and vertebral fracture. These findings can inform clinicians and health managers about the importance of pain management and exercise interventions in health care for this group. Future research should address interventions targeting both physical function and pain with HRQoL as an outcome. REGISTRATION:ClincialTrials.gov Identifier: NCT02781974. Registered 18.05.16. Retrospectively registered.
Project description:BACKGROUND:Osteoporotic vertebral fractures are common, and are associated with reduced functioning and health related quality of life. The primary aims of this randomized controlled trial are to examine the immediate and long-term effects of a 12-weeks supervised group exercise programme on habitual walking speed in older women with osteoporosis and a history of vertebral fracture. The secondary aims are to examine the immediate and long-term effects of the exercise program on physical fitness, fear of falling and quality of life. METHODS:The study is a single-blinded randomized controlled trial. Women aged 65 years or older with osteoporosis and a history of vertebral fracture are included. The intervention group receives a 12-week multicomponent exercise programme, including resistance training combined with balance training. The control group receives usual care. Adherence to the programme will be of importance for the internal validity of the study. Participants in the exercise group who don't attend will be followed up with motivational phone calls. The primary outcome is habitual walking speed over 10 m. Secondary outcomes are health related quality of life (Qualeffo-41, SF-36), physical activity (I-PAQ), Patient Specific Functional Scale, Fear of falling (FES-1) and physical fitness (Senior Fitness test, Functional reach test, 4 square step test, grip strength). Sample size, based on the primary outcome, is 150 participants randomized into the two arms on a 1:1 allocation, including an estimated 20% drop out. Descriptive data will be reported as mean (standard deviation), median (range) or count (percent) as appropriate. The data will be analysed following the intention-to-treat principle. Between group differences in primary and secondary outcomes at 3 months follow-up will be assessed using linear regression models with respective outcome at baseline as covariate and the randomised group as factor. DISCUSSION:This trial will generate new knowledge on the effects of a multicomponent exercise programme among women over 65 years with osteoporosis and a history of vertebral fracture, knowledge that is of importance for clinicians, health managers and policy makers. TRIAL REGISTRATION:ClincialTrials.gov Identifier: NCT02781974 . Registered 18.05.16. Retrospectively registered.
Project description:A quasi-experimental pilot study was performed to determine the feasibility and safety of an Adapted Physical Activity (APA) protocol and its effect on health-related quality of life (HRQOL), fear of falling, pain, and physical performance in women with osteoporosis-related vertebral fractures. Forty-four post-menopausal women (mean age: 67.6 ± 4.6) with osteoporotic vertebral fractures were assigned to an exercise group (APA group = 26) who attended a six-month exercise protocol that included postural and muscular reinforcement exercises, and a control group (CG = 18) who was asked to maintain their current lifestyle. At baseline and six months after baseline, HRQOL was measured as primary outcome by the Assessment of Health Related Quality of Life in Osteoporosis (ECOS-16) questionnaire. Secondary outcomes were fear of falling (Fall Efficacy Scale International, FES-I), lumbar back pain (Visual Analogue Scale-VAS), functional exercise capacity (Six Minutes Walking Test-6MWT, Borg scale), balance and gait (Tinetti Scale), and flexibility of the column (Chair Sit-and-Reach). The effects of the intervention were analyzed by comparison within groups and between groups. Effect sizes (ES) were calculated using Cohen's d. All the outcomes significantly improved in the APA group, while they remained unchanged in the CG. After adjustment for unbalanced variables, the comparison between groups showed significant effects of the intervention for ECOS-16-score, functional exercise capacity, balance, and gait. The exercise program had big effect sizes on HRQOL (ES = 1.204), fear of falling (ES = 1.007), balance (ES = 0.871), and functional exercise capacity (ES = 1.390). Good adherence (75.8%) and no injuries were observed. Due to its feasibility, safety, and effectiveness, the proposed exercise protocol can be adopted in APA programs addressed to patients with osteoporosis-related vertebral fractures.
Project description:We describe the pre-planned interim analysis of fracture outcomes, health-related quality of life (HRQoL) and back pain in patients with severe osteoporosis treated with teriparatide for up to 24 months in the Extended Forsteo (Forsteo(®) is a registered trade name of Eli Lilly and Company) Observational Study (ExFOS), a prospective, multinational, observational study. Data on incident clinical fractures, HRQoL (EQ-5D questionnaire) and back pain [100 mm visual analogue scale (VAS)] were collected. The number of patients with fractures was summarised in 6-month intervals and fracture rate over each 6-month period was assessed using logistic regression for repeated measures. Changes from baseline in EQ-5D and back pain VAS were analysed using mixed models for repeated measures. Of 1454 patients in the active treatment cohort, 90.6 % were female and 14.4 % were taking glucocorticoids. During teriparatide treatment (median duration 23.7 months), 103 patients (7.1 %) sustained a total of 122 incident clinical fractures (21 % vertebral, 79 % non-vertebral). A 49 % decrease in the odds of fractures and a 75 % decrease in the odds of clinical vertebral fractures were observed in the >18- to 24-month period versus the first 6-month period (both p < 0.05). EQ-5D scores and back pain VAS scores were significantly improved from baseline at each post-baseline observation during teriparatide treatment. In conclusion, patients with severe osteoporosis showed a significant reduction in the incident fracture rate during 24 months of teriparatide treatment in routine clinical practice, accompanied by a significant improvement in HRQoL and reduction in back pain. Results should be interpreted in the context of the non-controlled design of this observational study.
Project description:BACKGROUND:Exercise is recommended for individuals with vertebral fractures, but few studies have investigated the effect of exercise on outcomes of importance for this population. Post-intervention effects of exercise are even less studied. The objective of this study was to evaluate habitual walking speed and other health-related outcomes after cessation of a 3-month exercise intervention. METHODS:This follow-up study was conducted 3?months post-intervention of a randomised controlled trial. A total of 149 community-dwelling Norwegian women aged 65?years or older, diagnosed with osteoporosis and vertebral fracture were randomised into either exercise or control group. Primary outcome was habitual walking speed at 3?months. Secondary outcomes were other measures of physical fitness - including the Four Square Step Test (FSST), functional reach, grip strength and Senior Fitness Test - measures of health-related quality of life and fear of falling. Herein we report secondary data analysis of all outcomes at 6?months (3?months post-intervention). Data were analysed according to the intention-to-treat principle, linear mixed regression models were employed. RESULTS:For the primary outcome, habitual walking speed, there was no statistically significant difference between groups (0.03?m/s, 95%CI -?0.02 to 0.08, p =?0.271) at the 3-month post-intervention follow-up. For secondary outcomes of physical fitness, statistically significant differences in favour of the intervention group were found for balance using the FSST (-?0.68?s, 95%CI -?1.24 to -?0.11, p =?0.019), arm curl (1.3, 95%CI 0.25 to 2.29, p =?0.015), leg strength using the 30-s sit to stand (1.56, 95%CI 0.68 to 2.44, p =?0.001) and mobility using the 2.45-m up and go (-?0.38?s, 95%CI -?0.74 to -?0.02, p =?0.039). There was a statistically significant difference between the groups regarding fear of falling in favour of the intervention group (-?1.7, 95%CI -?2.97 to -?0.38, p =?0.011). No differences between groups were observed for health-related quality of life. CONCLUSION:The results show the improved effects of a multicomponent exercise programme on outcomes like muscle strength, balance and mobility as well as fear of falling in a group of older women with osteoporosis and vertebral fracture 3?months post-intervention. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02781974 . Registered 25.05.16. Retrospectively registered.
Project description:In men, the association between poor physical performance and likelihood of incident vertebral fractures is unknown. Using data from the MrOS study (N?=?5958), we describe the association between baseline physical performance (walking speed, grip strength, leg power, repeat chair stands, narrow walk [dynamic balance]) and incidence of radiographic and clinical vertebral fractures. At baseline and follow-up an average of 4.6 years later, radiographic vertebral fractures were assessed using semiquantitative (SQ) scoring on lateral thoracic and lumbar radiographs. Logistic regression modeled the association between physical performance and incident radiographic vertebral fractures (change in SQ grade ?1 from baseline to follow-up). Every 4 months after baseline, participants self-reported fractures; clinical vertebral fractures were confirmed by centralized radiologist review of the baseline study radiograph and community-acquired spine images. Proportional hazards regression modeled the association between physical performance with incident clinical vertebral fractures. Multivariate models were adjusted for age, bone mineral density (BMD, by dual-energy X-ray absorptiometry [DXA]), clinical center, race, smoking, height, weight, history of falls, activity level, and comorbid medical conditions; physical performance was analyzed as quartiles. Of 4332 men with baseline and repeat radiographs, 192 (4.4%) had an incident radiographic vertebral fracture. With the exception of walking speed, poorer performance on repeat chair stands, leg power, narrow walk, and grip strength were each associated in a graded manner with an increased risk of incident radiographic vertebral fracture (p for trend across quartiles <0.001). In addition, men with performance in the worst quartile on three or more exams had an increased risk of radiographic fracture (odds ratio [OR]?=?1.81, 95% confidence interval [CI] 1.33-2.45) compared with men with better performance on all exams. Clinical vertebral fracture (n =149 of 5813, 2.6%) was not consistently associated with physical performance. We conclude that poorer physical performance is associated with an increased risk of incident radiographic (but not clinical) vertebral fracture in older men.
Project description:Using data from the Study of Osteoporotic Fractures (SOF), several clinical characteristics predictive of near-term (1-year) risk of hip and non-vertebral fracture among elderly osteoporotic women were identified, and a subset of those for hip fracture was incorporated into a risk assessment tool. Additional research is needed to validate study findings.While several risk factors are known to contribute to long-term fracture risk in women with osteoporosis, factors predicting fracture risk over a shorter time horizon, such as over a 1-year period, are less well-established.We utilized a repeated-observations design and data from the Study of Osteoporotic Fractures to identify factors contributing to near-term risk of hip fracture and any non-vertebral fracture, respectively, among osteoporotic women aged ?65 years. Potential predictors of hip fracture and any non-vertebral fracture over the 1-year period subsequent to each qualifying SOF exam were examined using multivariable frailty models. Because the discriminative ability of the hip fracture model was acceptable, a corresponding risk-prediction tool was also developed.Study population included 2499 women with osteoporosis, who contributed 6811 observations. Incidence of fracture in the 1-year period subsequent to each exam was 2.2% for hip fracture and 6.6% for any non-vertebral fracture. Independent predictors of hip fracture included low total hip T-score, prior fracture, and risk factors for falls (multivariable model c-statistic = 0.71 (95% CI 0.67-0.76)). Independent predictors of any non-vertebral fracture included age, total hip T-score, prior falls, prior fracture, walking speed, Parkinson's disease or stroke, and smoking (multivariable model c-statistic = 0.62 (0.59-0.65)).Several clinical characteristics predictive of hip and non-vertebral fracture within a 1-year follow-up period among elderly women with osteoporosis were identified, and a subset of those for hip fracture was incorporated into a risk assessment tool. Assessment of these risk factors may help guide osteoporosis treatment choices by identifying patients in whom there is urgency to treat. Additional research is needed to validate the findings of this study and the accuracy of the risk assessment tool.
Project description:BACKGROUND: Some risk factors for low-energy wrist fracture have been identified. However, self-reported measures such as health-related quality of life (HRQOL) have not been examined as potential risk factors for wrist fracture. The aims of this study were to compare HRQOL prior to a low-energy wrist fracture in elderly patients (>or= 50 years) with HRQOL in age- and sex-matched controls, and to explore the association between HRQOL and wrist fracture after adjusting for known risk factors for fracture such as age, weight, osteoporosis and falls. METHODS: Patients with a low-energy wrist fracture (n = 181) and age- and sex-matched controls (n = 181) were studied. Shortly after fracture (median 10 days), patients assessed their HRQOL before fracture using the Short Form 36 (SF-36). Statistical tests included t tests and multivariate logistic regression analysis. RESULTS: Several dimensions of HRQOL were significantly associated with wrist fracture. The direction of the associations with wrist fracture varied between the different sub-dimensions of the SF-36. After controlling for demographic and clinical variables, higher scores on general health (odds ratio (OR) = 1.31, 95% confidence interval (CI) = 1.10-1.56), bodily pain (OR = 1.18, 95% CI = 1.03-1.34) and mental health (OR = 1.39, 95% CI = 1.09-1.79) were related to an increased chance of being a wrist fracture patient rather than a control. In contrast, higher scores on physical role limitation (OR = 0.87, 95% CI = 0.79-0.95) and social function (OR = 0.65, 95% CI 0.53-0.80) decreased this chance. Significant associations with wrist fracture were also found for living alone (OR = 1.91, 95% CI 1.07-3.4), low body mass index (BMI) (OR = 0.92, 95% CI 0.86-0.98), osteoporosis (OR = 3.30, 95% CI 1.67-6.50) and previous falls (OR = 2.01, 95% CI 1.16-3.49). CONCLUSION: Wrist fracture patients perceive themselves to be as healthy as the controls before fracture. Our data indicate that patients with favourable and unfavourable HRQOL measures may be at increased risk of wrist fracture.
Project description:BACKGROUND: Vertebral fractures could lead to reduced physical, social and mental functioning, and loss of personal independence. Therefore, during the treatment of osteoporosis, it has become necessary to examine the changes in everyday functioning, well-being and health related quality of life (HRQOL). To that effect, this study aims to translate, culturally adapt, and validate the Serbian version of Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) for patients with vertebral fractures. METHODS: Nine female patients with osteoporosis participated in the pre-validation study. A validation, case-control study included two groups of female patients: one that consisted of 50 female patients with osteoporosis, and with at least one vertebral fracture, and another one that consisted of 50 control patients with osteoporosis but without fractures. They completed the QUALEFFO-41 and the EuroQol group questionnaire with five dimensions (EQ-5D) twice within a month. The validation study examined internal consistency, concurrent validity, test-retest reliability, sensitivity and specificity. RESULTS: During the pre-validation study, three of the items in the QUALEFFO-41 were slightly changed. Afterwards, during the validation study, the statistically significant differences (adjusted for: age, duration of menopause, current employment and marital status) in the mean values of all domains and total scores between the groups were noted. For the case group, the internal consistency of the QUALEFFO-41 domains and of total questionnaire was above 0.70. The test-retest reliability was tested by the intraclass correlation coefficients (ICC) that were in range 0.87 - 0.96 for the case, and 0.15 - 0.83 for the control group. Correlations between the total scores of the QUALEFFO-41 and the EQ-5D health state value, for both groups were negative and statistically significant (r = -0.78, p<0.001 and r = -0.73, p<0.001, respectively). The QUALEFFO-41 had a better prediction of the value of HRQOL of cases compared to the generic questionnaire EQ-5D (the AUC difference was 0.099, p = 0.013). CONCLUSIONS: The Serbian QUALEFFO-41 version is reliable, valid, sensitive and predictive for examinations of HRQOL in patients with prevalent vertebral fractures and can be used in further studies.
Project description:BACKGROUND: To describe the health related quality of life in a population sample of postmenopausal women over the age of 50 and resident in the city of Valencia (Spain), according to the presence/absence of osteoporosis and the severity of prevalent morphometric vertebral fractures. METHODS: A cross-sectional age-stratified population-based sample of 804 postmenopausal women of 50 years of age and older were assessed with the SF-12 questionnaire. Information about demographic features, lifestyle, clinical features, educational level, anti-osteoporotic and other treatments, comorbidities and risk factors for osteoporosis were collected using an interviewer-administered questionnaire and densitometric evaluation of spine and hip and spine x-rays were carried out. RESULTS: In the non-adjusted analysis, mild and moderate-severe vertebral fractures were associated with decreased scores in the SF-12 Physical Component Summary (PCS) but not in the Mental Component Summary (MCS), while densitometric osteoporosis with no accompanying fracture was not associated with a worse health related quality of life. In multivariate analysis worse PCS scores were associated to the age groups over 70 (-2.43 for 70-74 group and -2.97 for 75 and older), chronic conditions (-4.66, -6.79 and -11.8 according to the presence of 1, 2 or at least 3 conditions), obesity (-5.35), peripheral fracture antecedents (-3.28), hypoestrogenism antecedents (-2.61) and the presence of vertebral fracture (-2.05). CONCLUSIONS: After adjusting for confounding factors, the physical components of health related quality of life were significantly lower in women with prevalent osteoporotic vertebral fractures than in women--osteoporotic or not--without vertebral fractures.
Project description:BACKGROUND:Falls and injuries in older adults have significant consequences and costs, both personal and to society. Although having a high incidence of falls, high prevalence of fear of falling and a lower quality of life, older adults receiving home care are underrepresented in research on older fallers. The objective of this study is to determine the associations between health-related quality of life (HRQOL), fear of falling and physical function in older fallers receiving home care. METHODS:This study employed cross-sectional data from baseline measurements of a randomised controlled trial. 155 participants, aged 67+, with at least one fall in the previous year, from six Norwegian municipalities were included. Data on HRQOL (SF-36), physical function and fear of falling (FES-I) were collected in addition to demographical and other relevant background information. A multivariate regression model was applied. RESULTS:A higher score on FES-I, denoting increased fear of falling, was significantly associated with a lower score on almost all subscales of SF-36, denoting reduced HRQOL. Higher age was significantly associated with higher scores on physical function, general health, mental health and the mental component summary. This analysis adjusted for sex, education, living alone, being at risk of or malnourished, physical function like balance and walking speed, cognition and number of falls. CONCLUSION:Fear of falling is important for HRQOL in older fallers receiving home care. This association is independent of physical measures. Better physical function is significantly associated with higher physical HRQOL. Future research should address interventions that reduce fear of falling and increase HRQOL in this vulnerable population. TRIAL REGISTRATION:ClinicalTrials.gov. NCT02374307 . First registration, 16 February 2015. First enrolment of participants, February 2016.