Functional-task exercise versus resistance strength exercise to improve daily function in older women: a randomized, controlled trial.

OBJECTIVES: To determine whether a functional-task exercise program and a resistance exercise program have different effects on the ability of community-living older people to perform daily tasks. DESIGN: A randomized, controlled, single-blind trial. SETTING: Community leisure center in Utrecht, the Netherlands. PARTICIPANTS: Ninety-eight healthy women aged 70 and older were randomly assigned to the functional-task exercise program (function group, n=33), a resistance exercise program (resistance group, n=34), or a control group (n=31). Participants attended exercise classes three times a week for 12 weeks. MEASUREMENTS: Functional task performance (Assessment of Daily Activity Performance (ADAP)), isometric knee extensor strength (IKES), handgrip strength, isometric elbow flexor strength (IEFS), and leg extension power were measured at baseline, at the end of training (at 3 months), and 6 months after the end of training (at 9 months). RESULTS: The ADAP total score of the function group (mean change 6.8, 95% confidence interval (CI)=5.2-8.4) increased significantly more than that of the resistance group (3.2, 95% CI=1.3-5.0; P=.007) or the control group (0.3, 95% CI=-1.3-1.9; P<.001). Moreover, the ADAP total score of the resistance group did not change significantly compared with that of the control group. In contrast, IKES and IEFS increased significantly in the resistance group (12.5%, 95% CI=3.8-21.3 and 8.6%, 95% CI=3.1-14.1, respectively) compared with the function group (-2.1%, 95% CI=-5.4-1.3; P=.003 and 0.3%, 95% CI=-3.6-4.2; P=.03, respectively) and the control group (-2.7%, 95% CI=-8.6-3.2, P=.003 and 0.6%, 95% CI=-3.4-4.6; P=.04, respectively). Six months after the end of training, the increase in ADAP scores was sustained in the function group (P=.002). CONCLUSION: Functional-task exercises are more effective than resistance exercises at improving functional task performance in healthy elderly women and may have an important role in helping them maintain an independent lifestyle.

Vitamin D deficiency, muscle function, and falls in elderly people.

An inadequate serum vitamin D status is commonly seen in elderly people as the result of various risk factors interacting in this population. Apart from the well-known effects on bone metabolism, this condition is also associated with muscle weakness, predominantly of the proximal muscle groups. Muscle weakness below a certain threshold affects functional ability and mobility, which puts an elderly person at increased risk of falling and fractures. Therefore, we wanted to determine the rationale behind vitamin D supplementation in elderly people to preserve and possibly improve muscle strength and subsequently functional ability. From experimental studies it was found that vitamin D metabolites directly influence muscle cell maturation and functioning through a vitamin D receptor. Vitamin D supplementation in vitamin D-deficient, elderly people improved muscle strength, walking distance, and functional ability and resulted in a reduction in falls and non-vertebral fractures. In healthy elderly people, muscle strength declined with age and was not prevented by vitamin D supplementation. In contrast,severe comorbidity might affect muscle strength in such a way that restoration of a good vitamin D status has a limited effect on functional ability. Additional research is needed to further clarify to what extent vitamin D supplementation can preserve muscle strength and prevent falls and fractures in elderly people.

The influence of tibolone on quality of life in postmenopausal women.

OBJECTIVES: To examine the effect of tibolone, a synthetic steroid with tissue-specific activity, on quality of life in a randomised, double-blind, placebo-controlled study in healthy postmenopausal women. MATERIAL AND METHODS: A total of 85 women (54.2+/-4.7 years), were randomised to 2.5 mg tibolone (Livial) or to identically appearing placebo pills daily for 12 months. Quality of life was assessed with the Nottingham Health Profile (NHP). Also, information on the occurrence of climacteric complaints and incidences of vaginal bleeding/spotting was gathered. RESULTS: Compared to baseline values, the tibolone group significantly improved on three out of six NHP domains: overall 46.8-25.3, emotional reactions 6.8-2.9 and sleep 19.0-7.2. In the placebo group a significant difference from baseline was observed on the 'physical mobility' parameter: 6.9-3.0. Significant between-group difference was only reached on the domains 'sleep': tibolone 7.2 versus placebo 15.2 and 'physical mobility': tibolone 3.8 versus placebo 3.0. The occurrence of hot flushes and nightly sweats was significantly lower in the tibolone group compared to placebo after 12 months of treatment. Throughout the study period a total of four women in the placebo, compared to 16 women in the tibolone group, reported vaginal bleeding/spotting. CONCLUSIONS: A trend favouring tibolone was observed. However, improvements from baseline were only reflected in a significant between-group difference on the domains of sleep and physical mobility. The limited sample size might have caused this ambiguity. Further research in a larger population is recommended to clear this inconsistency.

[Charles Bonnet syndrome]. / Het bonnetsyndroom.

BACKGROUND: Charles Bonnet syndrome is characterised by complex visual hallucinations in patients who have visual disturbances but no cognitive disorders. The diagnosis is often missed. CASE DESCRIPTION: An 88-year-old vital woman was referred to the emergency department due to anxiety and restlessness. Her symptoms began after she had started using antipsychotic drugs for visual hallucinations. The patient's visual acuity appeared to be markedly reduced. The antipsychotics were discontinued and the reason behind the patient's symptoms was explained to her: Charles Bonnet syndrome. The anxiety and restlessness disappeared and the frequency of the hallucinations declined. CONCLUSION: This patient had Charles Bonnet syndrome. If visual hallucinations occur for the first time after the 40th year of life, a somatic cause should first be ruled-out. Refraining from treating Charles Bonnet syndrome with pharmacological agents is advised in light of their many side effects and little evidence of being beneficial for this condition.

Muscle strength and mobility in vitamin D-insufficient female geriatric patients: a randomized controlled trial on vitamin D and calcium supplementation.

BACKGROUND AND AIMS: Insufficient vitamin D status, commonly found in older people, has been associated with muscle weakness which, in old age, impairs mobility and is a risk factor for falling. In a randomized, double-blind placebo-controlled trial, we tested the hypothesis that vitamin D + calcium supplementation improves muscle strength and mobility, compared with calcium mono-therapy in vitamin D-insufficient female geriatric patients. METHODS: Seventy female geriatric patients >65 years of age with serum 25-hydroxyvitamin D3 (25OHD) concentrations between 20 and 50 nmol/L, visiting an outpatient geriatric department, were included. Participants received either cholecalciferol 400 IU/day + calcium 500 mg/day (D/Cal group) or a placebo + calcium 500 mg/day (Plac/Cal group) for 6 months. At baseline and 6 months, muscle strength, power and functional mobility were tested. RESULTS: At baseline, 25OHD was significantly (p<0.05) associated with knee extension strength (r=0.42), handgrip strength (r=0.28), leg extension power (r=0.34), Timed Get Up and Go (r=-0.31) and Modified Cooper test (r=0.44). At 6 months, a significant difference in 25OHD (77.2 vs 41.6 nmol/L, p<0.001) and 1,25OHD was found between the two groups. Significantly improving vitamin D status in the D/Cal group compared with the Plac/Cal group did not result in a significant difference in strength or functional mobility between the two groups. CONCLUSIONS: Daily 400 IU vitamin D + 500 mg calcium supplementation is not enough to significantly improve strength or mobility in vitamin D-insufficient female geriatric patients.

Raloxifene and body composition and muscle strength in postmenopausal women: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To compare the effects of raloxifene and placebo on body composition and muscle strength. DESIGN: Randomized, double-blind, placebo-controlled trial involving 198 healthy women aged 70 years or older conducted between July 2003 and January 2008 at the University Medical Centre, Utrecht, The Netherlands. METHODS: Participants were randomly assigned to receive raloxifene 60 mg or placebo daily for 12 months. Measurements were taken at baseline, 3, 6, and 12 months, and change from baseline was calculated. Main outcome measures were body composition (bioelectrical impedance analysis), muscle strength, and muscle power (maximum voluntary isometric knee extension strength, explosive leg extensor power, and handgrip strength). RESULTS: At 12 months, the body composition of women taking raloxifene was significantly different from that of women taking placebo: fat-free mass (FFM) had increased by a mean of 0.83 (2.4) kg in the raloxifene group versus 0.03 (1.5) kg in the placebo group (P=0.05), and total body water had increased by a mean of 0.6 (1.8) litres in the raloxifene group versus a decrease of 0.06 (1.1) litres in the placebo group (P=0.02). Muscle strength and power were not significantly different. CONCLUSION: Raloxifene significantly changed body composition (increased FFM; increased water content) compared with placebo in postmenopausal women.

Raloxifene improves verbal memory in late postmenopausal women: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The aim of this study was to examine the effects of raloxifene compared with those of placebo on verbal memory, mental processing speed, depression, anxiety, and quality of life. METHODS: A randomized, double-blind, placebo-controlled trial of 213 healthy women 70 years or older was conducted between July 2003 and January 2008 at the University Medical Centre Utrecht, the Netherlands. Participants were randomly assigned to receive raloxifene (60 mg) or placebo daily for 12 months. Measurements were taken at baseline and after 3, 6, and 12 months. The change in scores from baseline was calculated. The main outcome measures were direct and delayed verbal memory (Groningen 15 Words test), mental processing speed (Trails B test), mood/depression (Geriatric Depression Scale), anxiety (State-Trait Anxiety Inventory 1 and 2), and quality of life (Women's Health Questionnaire and EuroQol-5 dimensional questionnaire). RESULTS: Direct verbal memory improved significantly with raloxifene compared with placebo: the women receiving raloxifene repeated more words in the words A + B test than did the women receiving placebo (P = 0.025). At 12 months, the change from baseline was 16 words in the raloxifene group and 10 words in the placebo group. In the words A test, direct repetition was also significantly better among women receiving raloxifene than among women receiving placebo (P = 0.023), with the change from baseline in the number of words repeated being nine words in the raloxifene group and six words in the placebo group at 12 months. CONCLUSIONS: In postmenopausal women, raloxifene gave significantly improved verbal memory when compared with placebo.

Predicting osteoporosis in patients with a low-energy fracture.

The multicenter cross-sectional study was designed to develop a simple rule to predict the risk of osteoporosis in the patients with a low-energy fracture (LEF). Furthermore, we aimed to investigate the incidence of fall-related risk factors. We included 206 patients with age over 50 and an LEF at the emergency room. All patients underwent osteoporosis and fall risk assessment and dual-energy X-ray absorptiometry (DEXA) of both hips and the lumbar spine. The incidence of osteoporosis in our study population was 41% (84 cases of 206). Fifty-four percent of the patients reported at least one fall-related risk factor. Mobility problems occurred in 31% and osteoarthritis in 19%. The final osteoporosis prediction rule included age, positive family history, immobility, and low-body weight. The discrimination of the rule after correction for over-optimism was good (receiver operating curve (ROC)=ROC area=0.79). This simple rule may be helpful to select patients who need further osteoporosis assessment.

Efficacy of tibolone and raloxifene for the maintenance of skeletal muscle strength, bone mineral density, balance, body composition, cognitive function, mood/depression, anxiety and quality of life/well-being in late postmenopausal women >/= 70 years: study design of a randomized, double-blind, double-dummy, placebo-controlled, single-center trial.

BACKGROUND: Postmenopausal women are prone to develop functional disabilities as a result of reduction in muscle strength and muscle mass caused by diminished levels of female sex hormones. While hormone replacement therapy may counteract these changes, conventional hormone replacement therapy is associated with potential harmful effects, such as an increased risk of breast cancer, and its prescription is not recommended. For this reason newer alternative drugs, such as tibolone, a synthetic steroid with estrogenic, progestogenic and androgenic activity, and raloxifene, a selective estrogen receptor modulator, may be more appropriate. This trial investigates the effect of tibolone and raloxifene on muscle strength. METHODS: We recruited 318 elderly women in our single-center randomized, double-blind, double-dummy, placebo-controlled trial. Participants were randomized to tibolone 1.25 mg (Org OD 14, Organon NV, the Netherlands) plus placebo, raloxifene 60 mg (Evista(R), Eli Lilly, United States) plus placebo or two placebo tablets daily for 24 months.The primary aim is to determine if there is a difference between tibolone and placebo or if there is a difference between raloxifene and placebo. Primary endpoints are muscle strength and bone mineral density. The secondary endpoints are postural balance, body composition, cognitive function, anxiety, mood and quality of life. The secondary aim is to determine if there is a difference between tibolone and raloxifene. The measure of effect is the change from the baseline visit to the visits after 3 months, 6 months, 12 months, and 24 months. A follow-up measurement is planned at 30 months to determine whether any effects are sustained after cessation of the study. By December 2007 the blind will be broken and the data analyzed. TRIAL REGISTRATION NUMBER: NTR: 1232.

The effect of functional tasks exercise and resistance exercise on health-related quality of life and physical activity. A randomised controlled trial.

BACKGROUND: Data regarding the effect of exercise programmes on older adults' health-related quality of life (HRQOL) and habitual physical activity are inconsistent. OBJECTIVE: To determine whether a functional tasks exercise programme (enhances functional capacity) and a resistance exercise programme (increases muscle strength) have a different effect on the HRQOL and physical activity of community-dwelling older women. METHODS: Ninety-eight women were randomised to a functional tasks exercise programme (function group), a resistance exercise programme (resistance group), or normal activity group (control group). Participants attended exercise classes three times a week for 12 weeks. The SF-36 Health Survey questionnaire and self-reported physical activity were obtained at baseline, directly after completion of the intervention (3 months), and 6 months later (9 months). RESULTS: At 3 months, no difference in mean change in HRQOL and physical activity scores was seen between the groups, except for an increased SF-36 physical functioning score for the resistance group compared with the control group (p = 0.019) and the function group (p = 0.046). Between 3 and 9 months, the self-reported physical functioning score of the function group decreased to below baseline (p = 0.026), and physical activity (p = 0.040) decreased in the resistance group compared with the function group. CONCLUSIONS: Exercise has a limited effect on the HRQOL and self-reported physical activity of community-living older women. Our results suggest that in these subjects HRQOL measures may be affected by ceiling effects and response shift. Studies should include performance-based measures in addition to self-report HRQOL measures, to obtain a better understanding of the effect of exercise interventions in older adults.

Reliability and validity of the Assessment of Daily Activity Performance (ADAP) in community-dwelling older women.

BACKGROUND AND AIMS: The Assessment of Daily Activity Performance (ADAP) test was developed, and modeled after the Continuous-scale Physical Functional Performance (CS-PFP) test, to provide a quantitative assessment of older adults' physical functional performance. The aim of this study was to determine the intra-examiner reliability and construct validity of the ADAP in a community-living older population, and to identify the importance of tester experience. METHODS: Forty-three community-dwelling, older women (mean age 75 yr +/-4.3) were randomized to the test-retest reliability study (n=19) or validation study (n=24). The intra-examiner reliability of an experienced (tester 1) and an inexperienced tester (tester 2) was assessed by comparing test and retest scores of 19 participants. Construct validity was assessed by comparing the ADAP scores of 24 participants with self-perceived function by the SF-36 Health Survey, muscle function tests, and the Timed Up and Go test (TUG). RESULTS: Tester 1 had good consistency and reliability scores (mean difference between test and retest scores (DIF), -1.05+/-1.99; 95% confidence interval (CI), -2.58 to 0.48; Cronbach's alpha (alpha) range, 0.83 to 0.98; intraclass correlation (ICC) range, 0.75 to 0.96; Limits of Agreement (LoA), -2.58 to 4.95). Tester 2 had lower reliability scores (DIF, -2.45+/-4.36; 95% CI, -5.56 to 0.67; alpha range, 0.53 to 0.94; ICC range, 0.36 to 0.90; LoA, -6.09 to 10.99), with a systematic difference between test and retest scores for the ADAP domain lower-body strength (-3.81; 95% CI, -6.09 to -1.54), ADAP correlated with SF-36 Physical Functioning scale (r=0.67), TUG test (r=-0.91) and with isometric knee extensor strength (r=0.80). CONCLUSIONS: The ADAP test is a reliable and valid instrument. Our results suggest that testers should practise using the test, to improve reliability, before applying it to clinical settings.

Tibolone does not affect muscle power and functional ability in healthy postmenopausal women.

Maintenance of neuromuscular function into old age is critical to maintain normal daily activity and functional independence. Maximal muscle strength declines with age, and the age-related loss in power might be even greater. An accelerated loss of muscle strength and power has been observed in women around the time of the menopause. The aim of the present study was to examine the effects of tibolone, a synthetic steroid with oestrogenic, progestogenic and androgenic activities, on muscle power, endurance and functional ability. A total of 85 healthy women, between 1 and 15 years postmenopausal, were recruited from local paper advertisements. Participants were randomly assigned to 2.5 mg of tibolone or to placebo pills of identical appearance; pills were taken daily for 12 months, orally in the morning. Muscle power was assessed as explosive leg extensor power. Endurance was measured on a 2 min walk test and a 3.5 m walk. Functional ability was determined with the timed Get Up and Go test and a Postural/Locomotor/Manual test. No significant between-group differences were observed for any of the parameters. Possible explanations for this lack of effect are either the absence of an effect of tibolone on muscle power and functional ability, or that our participants were too far above their strength-related functional limits to derive benefit from intervention. Further research is required to resolve this issue.

Muscle strength and tibolone: a randomised, double-blind, placebo-controlled trial.

OBJECTIVE: To investigate the effects of tibolone, a tissue-specific compound with a mixed (estrogenic, progestogenic and androgenic) hormonal profile, on skeletal muscle strength in a group of healthy postmenopausal women. DESIGN: Randomised, parallel group, double-blind, placebo-controlled, single-centre trial conducted between August 1997 and July 1999. PARTICIPANTS: Eighty-five healthy women, between one and 15 years postmenopausal, (mean [SD] age, 54.2 [4.7] years) recruited from local paper advertisements. Participants were randomly assigned to 2.5 mg tibolone or to identically appearing placebo pills daily for 12 months, taken orally in the morning. METHODS: Both maximal handgrip strength, representing upper body strength, and maximal quadriceps strength, representing lower body strength, were measured isometrically. MAIN OUTCOME MEASURES: Treatment effect estimates (between group differences) in handgrip strength and isometric knee extension at last visit. RESULTS: Tibolone significantly (P = 0.04) increased handgrip strength compared with placebo (difference 0.99 kg, [95% CI 0.1-1.9]). No significant treatment effect (P = 0.61) was observed in isometric knee extension strength. Isometric strength adjusted for body mass index resulted in a trend favouring tibolone (P = 0.06). Individual trend analysis showed a significant difference in rate of change throughout the year (6.8% [95% CI 2.1-10.7]) favouring tibolone. CONCLUSIONS: Administration of tibolone increased handgrip strength in postmenopausal women compared with placebo. A trend indicating a positive effect in isometric knee extension strength adjusted for body mass index was observed. Tibolone seems to mitigate the menopause-related decline in muscle strength.

Functional tasks exercise versus resistance exercise to improve daily function in older women: a feasibility study.

OBJECTIVE: To evaluate the feasibility of a new functional tasks exercise program, designed to improve functional performance of community-dwelling older women, by comparing it with a resistance exercise program. DESIGN: A 12-week, randomized, single-blind pilot study. SETTING: A community leisure center. PARTICIPANTS: Twenty-four community-dwelling, medically stable women (mean age, 74.6+/-4.8 y) were randomized to the functional tasks exercises (function group) or the resistance exercises (resistance group). Three participants withdrew from the study. INTERVENTIONS: Exercises were given 3 times weekly for 12 weeks. The functional tasks exercise program aimed to improve daily tasks in the domains first affected in older adults, whereas the resistance exercise program focused on strengthening the muscle groups that are important for functional performance. MAIN OUTCOME MEASURES: Participant satisfaction with the exercises, Assessment of Daily Activity Performance (ADAP), and, as a secondary outcome, muscle strength and power. RESULTS: Exercise adherence was 81% in the function group and 90% in the resistance group. Participants reported greater satisfaction with the resistance exercises than with the functional exercises. The ADAP total score improved with time (P =.001; mean change function group, 7.5 U; 95% confidence interval [CI], 2.1-12.8; resistance group, 2.8 U, 95% CI, -0.4 to 5.9), as did isometric knee extensor strength (P =.001; mean change function group, 6.4%; 95% CI, -1.6 to 14.5; resistance group, 14.4%; 95% CI, 6.4-22.2). Testing for differences in outcomes between the 2 groups showed no statistically significant differences. CONCLUSIONS: The functional tasks exercise program is feasible and shows promise of being more effective for functional performance than a resistance exercise program. A randomized controlled trial with a larger sample size is needed to test the difference between the 2 programs.

Strength, mobility and falling in women referred to a geriatric outpatient clinic.

BACKGROUND AND AIMS: Mobility impairment and falling have a multifactorial etiology in frail older people. Muscle weakness is one of the risk factors and is accessible to intervention. The aim of this study was to determine the most important contributors of mobility and indicators of fall occurrence in women referred to a geriatric outpatient clinic. METHODS: Mobility was assessed using the Timed 'Get-Up-and-Go' test (TGUG) and the modified Coopertest (COOP). Falling was assessed retrospectively and isometric knee extension force was measured using fixed dynamometry. Habitual physical activity was quantified using a questionnaire for the elderly. Height, weight, medical conditions and current medication were recorded. RESULTS: Isometric knee extension strength and habitual physical activity, which consisted predominantly of household work, were independent variables of performance on TGUG and COOP and together explained 57% of the variance in TGUG (r=0.75, p<0.001), and 64% of that in COOP, (r=0.80, p<0.001). Age, total number of medical conditions, and presence of cardiovascular disease were not significant in the model. Women in the lowest tertile of knee extension strength had a significantly higher probability of falling (0.75, 95% CI 0.56-0.91) compared with women in the highest tertile (0.27, 95% CI 0.14-0.50). CONCLUSIONS: Knee extension strength remains a strong determinant of mobility and fall occurrence in women referred to a geriatric outpatient clinic. Performing light to moderate household work remains independently associated with functional mobility.