Physical activity and health promotion for nursing staff in elderly care: a study protocol for a randomised controlled trial.

INTRODUCTION: Nursing staff is burdened by high workload and stress. Furthermore, heavy lifting, as well as transferring nursing home residents, cause lumbar tissue damage and back pain. Exercise intervention studies to reduce work-related problems are rare and the evidence for efficacy of studies among nurses is limited. Studies including targeted analysis of requirements are necessary to generate effective recommendations and tailored interventions for health promotion programmes. The purpose of this multicentred intervention study is to identify work-related problems, to implement health promotion programmes and to evaluate their effectiveness. METHODS AND ANALYSIS: A randomised controlled trial will be conducted, including a total of 48 nursing home facilities in eight regions of Germany with an estimated sample size of 700 nurses. Standardised ergonomics and posture training (10 weeks, once a week for 20-30 min) and subsequently, back-fitness training (12 weeks, once a week for 45-60 min) will be administered. Following the implementation of standardised health promotion programmes, further demand-oriented interventions can be implemented. The perceived exposure to work-related demands, work-related pain in different parts of the body, health-related quality of life, perceived stress, work-related patterns of behaviour and experience, presentism behaviour, work environment as well as general needs and barriers to health promotion, will be assessed at baseline (pre-test), at 10 weeks (post-test, after ergonomics training), at 22 weeks (post-test, after back-fitness training) and at 34 weeks of the programme (follow-up). ETHICS AND DISSEMINATION: The study was reviewed and approved by the local ethics committee of the University of Hamburg (AZ: 2018_168). The results of the study will be published in open-access and international journals. Furthermore, the results will be presented in the participating nursing homes and at national and international conferences. TRIAL REGISTRATION NUMBER: DRKS.de (DRKS00015241).

A multicomponent exercise intervention to improve physical functioning, cognition and psychosocial well-being in elderly nursing home residents: a study protocol of a randomized controlled trial in the PROCARE (prevention and occupational health in long-term care) project.

BACKGROUND: Older adults, who are living in nursing homes that provide a high level of long-term nursing care, are characterized by multimorbidity and a high prevalence of dependency in activities of daily living. Results of recent studies indicate positive effects of structured exercise programs during long-term care for physical functioning, cognition, and psychosocial well-being. However, for frail elderly the evidence remains inconsistent. There are no evidence-based guidelines for exercises for nursing home residents that consider their individual deficits and capacities. Therefore, high-quality studies are required to examine the efficacy of exercise interventions for this multimorbid target group. The purpose of this study is to determine the feasibility and efficacy of a multicomponent exercise intervention for nursing home residents that aims to improve physical and cognitive functioning as well as quality of life. METHODS: A two-arm single-blinded multicenter randomized controlled trial will be conducted, including 48 nursing homes in eight regions of Germany with an estimated sample size of 1120 individuals. Participants will be randomly assigned to either a training or a waiting time control group. For a period of 16 weeks the training group will meet twice a week for group-based sessions (45-60 min each), which will contain exercises to improve physical functioning (strength, endurance, balance, flexibility) and cognitive-motor skills (dual-task). The intervention is organized as a progressive challenge which is successively adapted to the residents' capacities. Physical functioning, cognitive performance, and quality of life will be assessed in both study groups at baseline (pre-test), after 16-weeks (post-treatment), and after 32-weeks (retention test, intervention group only). DISCUSSION: This study will provide information about the efficacy of a multicomponent exercise program in nursing homes (performance, recruitment). Results from this trial will contribute to the evidence of multicomponent exercises, which specifically focus on cognitive-motor approaches in the maintenance of mental and physical functioning. In addition, it will help to encourage older adults to actively engage in social life. Furthermore, the findings will lead to recommendations for health promotion interventions for frail nursing home residents. TRIAL REGISTRATION: The trial was prospectively registered at DRKS.de with the registration number DRKS00014957 on October 9, 2018.

Effects of Combined Whole-Body Electromyostimulation and Protein Supplementation on Local and Overall Muscle/Fat Distribution in Older Men with Sarcopenic Obesity: The Randomized Controlled Franconia Sarcopenic Obesity (FranSO) Study.

The primary aim of the project was to determine the combined effect of whole-body electromyostimulation (WB-EMS) and protein supplements on local and overall muscle/fat distribution in older man with sarcopenic obesity (SO). Community-dwelling (cdw) men ≥ 70 years with SO were randomly allocated to a WB-EMS and protein supplementation (n = 33) or a non-intervention control group (CG: n = 34). WB-EMS was conducted 1.5 sessions of 20 min/week for 16 weeks. Whey protein supplementation aimed to ensure a daily intake of 1.8 g/kg body mass. The primary study endpoint was muscle/fat distribution of the total intra-fascial volume of the mid-thigh as determined by MRI. The core secondary endpoint was appendicular muscle mass (ASMM) and trunk fat; subordinate secondary endpoint was lower-leg performance. Thigh lean muscle volume increased significantly in the WB-EMS&P (p < 0.001) and increased slightly in the CG (p = 0.435). In parallel, fat volume increased significantly in the CG (p < 0.001) and was maintained in the WB-EMS&P group (p = 0.728). Group differences for both parameters were significant (p = 0.033 and p = 0.002). ASMM and trunk fat also differed significantly (p < 0.001) between WB-EMS and CG, with significant positive changes in the WB-EMS&P (p < 0.001) and no relevant changes in the CG (p ≥ 0.458). Finally, changes of gait velocity, leg-extensor strength, and advanced lower extremity function of the WB-EMS&P group differed significantly from the CG (p ≤ 0.002). WB-EMS combined with whey protein supplements favorably affects local and overall muscle/fat distribution and lower limb functioning in cdw men 70+ with SO. Thus, this time-saving, joint-friendly, and highly customizable approach may be an option for people either unable or unmotivated to conduct intense (resistance) exercise protocols.Trial registration number NCT02857660 on http://www.clinicaltrials.gov .

Short time effect of a single session of intense whole-body electromyostimulation on energy expenditure. A contribution to fat reduction?

To determine the underlying mechanisms after 1 session of (intense) whole-body electromyostimulation (WB-EMS) on total energy expenditure (TEE) and resting metabolic rate (RMR), 16 subjects followed a standardized protocol of indirect calorimetry for up to 72 h in 12-h intervals. The single session significantly increased RMR by approximately 25% ± 10% (p < 0.001) and TEE by approximately 9.5% ± 1%, a net effect of ∼460 ± 50 kcal (WB-EMS vs. control group).

Effects of Whole-Body Electromyostimulation on Low Back Pain in People with Chronic Unspecific Dorsal Pain: A Meta-Analysis of Individual Patient Data from Randomized Controlled WB-EMS Trials.

In order to evaluate the favorable effect of whole-body electromyostimulation (WB-EMS) on low back pain (LBP), an aspect which is frequently claimed by commercial providers, we performed a meta-analysis of individual patient data. The analysis is based on five of our recently conducted randomized controlled WB-EMS trials with adults 60 years+, all of which applied similar WB-EMS protocols (1.5 sessions/week, bipolar current, 16-25 min/session, 85 Hz, 350 µs, and 4-6 s impulse/4 s impulse-break) and used the same pain questionnaire. From these underlying trials, we included only subjects with frequent-chronic LBP in the present meta-analysis. Study endpoints were pain intensity and frequency at the lumbar spine. In summary, 23 participants of the underlying WB-EMS and 22 subjects of the control groups (CG) were pooled in a joint WB-EMS and CG. At baseline, no group differences with respect to LBP intensity and frequency were observed. Pain intensity improved significantly in the WB-EMS (p < .001) and was maintained (p = .997) in the CG. LBP frequency decreased significantly in the WB-EMS (p < .001) and improved nonsignificantly in the CG (p = .057). Group differences for both LBP parameters were significant (p ≤ .035). We concluded that WB-EMS appears to be an effective training tool for reducing LBP; however, RCTs should further address this issue with more specified study protocols.

Whole-body electromyostimulation and protein supplementation favorably affect sarcopenic obesity in community-dwelling older men at risk: the randomized controlled FranSO study.

BACKGROUND: Sarcopenic obesity (SO) is a geriatric syndrome characterized by the disproportion between the amount of lean mass and fat mass. Exercise decreases fat and maintains muscle mass; however, older people fail to exercise at doses sufficient to affect musculoskeletal and cardiometabolic risk factors. The aim of this study was to evaluate the effect of whole-body electromyostimulation (WB-EMS), a time-efficient, joint-friendly and highly individualized exercise technology, on sarcopenia and SO in older men. MATERIALS AND METHODS: A total of 100 community-dwelling northern Bavarian men aged ≥70 years with sarcopenia and obesity were randomly (1-1-1) assigned to either 16 weeks of 1) WB-EMS and protein supplementation (WB-EMS&P), 2) isolated protein supplementation or 3) nonintervention control. WB-EMS consisted of 1.5×20 min (85 Hz, 350 µs, 4 s of strain to 4 s of rest) applied with moderate-to-high intensity while moving. We further generated a daily protein intake of 1.7-1.8 g/kg/body mass per day. The primary study end point was Sarcopenia Z-Score, and the secondary study end points were body fat rate (%), skeletal muscle mass index (SMI) and handgrip strength. RESULTS: Intention-to-treat analysis determined a significantly favorable effect of WB-EMS&P (P<0.001) and protein (P=0.007) vs control. Both groups significantly (P<0.001) lost body fat (WB-EMS&P: 2.1%; protein: 1.1%) and differed significantly (P≤0.004) from control (0.3%). Differences between WB-EMS&P and protein were significant for the Sarcopenia Z-Score (P=0.39) and borderline nonsignificant (P=0.051) for body fat. SMI increased significantly in both groups (P<0.001 and P=0.043) and decreased significantly in the control group (CG; P=0.033); differences between the verum groups and control were significant (P≤0.009). Handgrip strength increased in the WB-EMS group (1.90 kg; P<0.001; P=0.050 vs control) only. No adverse effects of WB-EMS or protein supplementation were recorded. CONCLUSION: WB-EMS&P is a safe and efficient method for tackling sarcopenia and SO in older men. However, the suboptimum effect on functional parameters should be addressed by increased voluntary activation during WB-EMS application.

Protein Supplementation to Augment the Effects of High Intensity Resistance Training in Untrained Middle-Aged Males: The Randomized Controlled PUSH Trial.

High intensity (resistance exercise) training (HIT) defined as a "single set resistance exercise to muscular failure" is an efficient exercise method that allows people with low time budgets to realize an adequate training stimulus. Although there is an ongoing discussion, recent meta-analysis suggests the significant superiority of multiple set (MST) methods for body composition and strength parameters. The aim of this study is to determine whether additional protein supplementation may increase the effect of a HIT-protocol on body composition and strength to an equal MST-level. One hundred and twenty untrained males 30-50 years old were randomly allocated to three groups: (a) HIT, (b) HIT and protein supplementation (HIT&P), and (c) waiting-control (CG) and (after cross-over) high volume/high-intensity-training (HVHIT). HIT was defined as "single set to failure protocol" while HVHIT consistently applied two equal sets. Protein supplementation provided an overall intake of 1.5-1.7 g/kg/d/body mass. Primary study endpoint was lean body mass (LBM). LBM significantly improved in all exercise groups (p ≤ 0.043); however only HIT&P and HVHIT differ significantly from control (p ≤ 0.002). HIT diverges significantly from HIT&P (p = 0.017) and nonsignificantly from HVHIT (p = 0.059), while no differences were observed for HIT&P versus HVHIT (p = 0.691). In conclusion, moderate to high protein supplementation significantly increases the effects of a HIT-protocol on LBM in middle-aged untrained males.

Effects of Whole-Body Electromyostimulation versus High-Intensity Resistance Exercise on Body Composition and Strength: A Randomized Controlled Study.

High-intensity (resistance) exercise (HIT) and whole-body electromyostimulation (WB-EMS) are both approaches to realize time-efficient favorable changes of body composition and strength. The purpose of this study was to determine the effectiveness of WB-EMS compared with the gold standard reference HIT, for improving body composition and muscle strength in middle-aged men. Forty-eight healthy untrained men, 30-50 years old, were randomly allocated to either HIT (2 sessions/week) or a WB-EMS group (3 sessions/2 weeks) that exercised for 16 weeks. HIT was applied as "single-set-to-failure protocol," while WB-EMS was conducted with intermittent stimulation (6 s WB-EMS, 4 s rest; 85 Hz, 350 ms) over 20 minutes. The main outcome parameters were lean body mass (LBM) as determined via dual-energy X-ray absorptiometry and maximum dynamic leg-extensor strength (isokinetic leg-press). LBM changes of both groups (HIT 1.25 ± 1.44% versus WB-EMS 0.93 ± 1.15%) were significant (p = .001); however, no significant group differences were detected (p = .395). Leg-extensor strength also increased in both groups (HIT 12.7 ± 14.7%, p = .002, versus WB-EMS 7.3 ± 10.3%, p = .012) with no significant (p = .215) between-group difference. Corresponding changes were also determined for body fat and back-extensor strength. Conclusion. In summary, WB-EMS can be considered as a time-efficient but pricy option to HIT-resistance exercise for people aiming at the improvement of general strength and body composition.

High Intensity Resistance Training Methods with and without Protein Supplementation to Fight Cardiometabolic Risk in Middle-Aged Males: A Randomized Controlled Trial.

Time-effective protocols may potentially increase people's compliance with exercise. The purpose of this paper was to compare the relative effects of 16 weeks of high intensity (resistance) training (HIT) with and without protein supplementation (HIT&P) and HVHIT (high volume/high intensity training) versus a nontraining control group on cardiometabolic risk factors. One hundred and twenty untrained males 30-50 years old were randomly assigned to 3 subgroups: (a) a HIT group; (b) a HIT&P group, and (c) a waiting-control group (phase I) that crossed over to (d) high volume/high intensity training (HVHIT) during the second study phase. HIT was defined as "single set to failure protocol" while HVHIT consistently applied two sets. Protein supplementation provided an overall intake of 1.5 g/kg/body mass. Primary study endpoint was the metabolic syndrome Z-Score (MetS-Z-Score). MetS-Z-Score significantly improved in all exercise groups (p ≤ 0.001) with no significant difference between HIT, HIT&P, and HVHIT (p ≥ 0.829). However, all the exercise groups differed significantly from the CG (p < 0.001) which deteriorated significantly (p = 0.039). In conclusion, all exercise protocols were similarly effective in improving cardiometabolic risk factors. Thus, HIT may be the best choice for people with low time budgets looking to improve their cardiometabolic health.

[(Very) high Creatinkinase concentration after exertional whole-body electromyostimulation application: health risks and longitudinal adaptations]. / Hohe Kreatinkinase-Werte nach exzessiver Ganzkörper-Elektromyostimulation: gesundheitliche Relevanz und Entwicklung im Trainingsverlauf.

Due to its individualization, time-efficiency and effectiveness Whole-body-Electromyo-stimulation (WB-EMS) becomes increasingly popular. However, recently (very) high Creatin-kinase concentration were reported, at least after initial WB-EMS-application. Thus, the aim of the study was to determine (1) WB-EMS induced increases of CK-concentration, (2) their impact on corresponding health parameters and (3) training-induced changes of CK-levels.Twenty-six healthy, sportive volunteers without previous experience with WB-EMS were included. Initial high intense WB-EMS application (bipolar, 85 Hz; 350 ms; intermittent, 20 min) led to an increase of the CK-level by the 117fold (28.545 ± 33.611 IU/l) of baseline. CK-peaks were detected after 72-96 h. Despite this pronounced "exertional rhabdomyolysis", we did not determine rhabdomyolysis-induced complications (e.g. acute renal failure, hyperkalemia, hypocalcaemia). After 10 weeks of WB-EMS (1 session/week) CK-reaction to intensive WB-EMS-Application was significantly blunted (906 ± 500 IE/l) and averaged in the area of conventional resistance exercise.In summary, intensity of WB-EMS should be carefully increased during the initial sessions.

Prevalence of sarcopenia in Germany and the corresponding effect of osteoarthritis in females 70 years and older living in the community: results of the FORMoSA study.

BACKGROUND: Although sarcopenia represents a challenging burden for health care systems around the world, its prevalence in the elderly population varies widely. The primary aim of the study was to determine the prevalence of sarcopenia in community-dwelling (CD) German women aged 70 years and older; the secondary aim was to assess the effect of osteoarthritis (OA) on sarcopenia prevalence in this cohort. METHODS: A total of 689 Caucasian females 18-35 years old and 1,325 CD females 70 years+ living in Northern Bavaria, Germany, were assessed during the initial phase of the FORMoSA research project. Anthropometry, total and regional muscle mass, were assessed by segmental multifrequency Bioelectrical Impedance Analysis. Further 10 m walking speed and handgrip strength were evaluated to apply the European Working Group on Sarcopenia in Older People definition of sarcopenia. Covariates were determined by questionnaires and interviews. RESULTS: Applying the algorithm of the European Working Group on Sarcopenia in Older People of two standard deviations below the mean value for appendicular skeletal muscle mass of a reference cohort of the young cohort (5.66 kg/m(2)), low gait speed (≤0.8 m/s), and low grip strength (<20 kg), the prevalence of sarcopenia in CD German females 70 years and older was 4.5% (70-79 years: 2.8% vs ≥80 years: 9.9%; P<0.001). Participants with OA at the hip and lower limbs (n=252) exhibited significantly higher rates of sarcopenia (OA: 9.1 vs non-OA: 3.5%). Of importance, anthropometric, demographic, health, and lifestyle parameters (except exercise participation) of our cohorts corresponded with Bavarian or German data for CD women 70 years+. CONCLUSION: The prevalence of sarcopenia in CD German females 70 years+ is relatively low. However, participants with OA at the hip or lower limbs were at increased risk for sarcopenia.

[Overweight and obesity in young adults: relevance of job-related changes of exercise on fat, lean body and body mass in students]. / Entwicklung von Übergewicht und Adipositas im jungen Erwachsenenalter - Stellenwert berufsbedingter Veränderungen des Sporttreibens auf Fettmasse, fettfreie Masse und Körpermasse bei Studenten.

Early adulthood is related to changes in lifestyle that negatively affect body weight and health. The aim of the study was to determine the effect of exercise changes on the development of weight and body composition in college students.Sixty-one randomly selected dental (ZMS) and 53 sport students (SLS) were accompanied over 5 years. Body mass, fat and lean body mass (LBM) were determined via DXA-technique. Exercise and physical activity were assessed by questionnaires and interviews.All exercise indices significantly increased in the SLS and significantly decreased in the ZMS. Physical activity slightly increased in both groups. Both cohorts comparably gained body mass, however, the increase in the SLS group can be attributed to LBM-changes with minor changes of fat-mass (2.4 % ± 3.3 % vs. 0.1 ± 1.0 %) whereas ZMS gained fat and LBM in a proportion of 2:1.Maintenance/increase of exercise compensate the negative effects of lifestyle changes on body composition during young adulthood.

Whole-Body Electromyostimulation to Fight Osteopenia in Elderly Females: The Randomized Controlled Training and Electrostimulation Trial (TEST-III).

Whole-body electromyostimulation (WB-EMS) has been shown to be effective in increasing muscle strength and mass in elderly women. Because of the interaction of muscles and bones, these adaptions might be related to changes in bone parameters. 76 community-living osteopenic women 70 years and older were randomly assigned to either a WB-EMS group (n = 38) or a control group (CG: n = 38). The WB-EMS group performed 3 sessions every 14 days for one year while the CG performed gymnastics containing identical exercises without EMS. Primary study endpoints were bone mineral density (BMD) at lumbar spine (LS) and total hip (thip) as assessed by DXA. After 54 weeks of intervention, borderline nonsignificant intergroup differences were determined for LS-BMD (WB-EMS: 0.6 ± 2.5% versus CG -0.7 ± 2.5%, P = .051) but not for thip-BMD (WB-EMS: -1.1 ± 1.9% versus CG: -0.8 ± 2.3%, P = .771). With respect to secondary endpoints, there was a gain in lean body mass (LBM) of 1.5% (P = .006) and an increase in grip strength of 8.4% (P = .000) in the WB-EMS group compared to CG. WB-EMS effects on bone are less pronounced than previously reported effects on muscle mass. However, for subjects unable or unwilling to perform intense exercise programs, WB-EMS may be an option for maintaining BMD at the LS.

Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III).

Most studies have confirmed the positive impact of resistance training on muscle mass and functional capacity in aging adults. However, due to physical limitation or a simple aversion against regular exercise, the majority of elderly subjects do not reach the exercise doses recommended for impacting strength or muscle mass. This led us to evaluate the effect of whole-body electromyostimulation (WB-EMS), a novel, time-efficient and smooth training technology, on body composition with special regard to sarcopenia. Seventy-six lean, non-sportive women (75 ± 4 years) were randomly assigned to either a WB-EMS group (WB-EMS, n = 38) that performed 18 min of WB-EMS (bipolar, 85 Hz) 3 sessions in 14 days (1.5 sessions/week) or a semi-active control group (aCG, n = 38). Body composition was assessed by dual-energy X-ray absorptiometry and maximum strength was evaluated using isometric techniques for trunk and legs. After 54 weeks of intervention, significant inter-group differences were determined for appendicular skeletal muscle mass (WB-EMS, 0.4 ± 2.2 % vs. aCG, -1.5 ± 3.1 %; p = 0.009), lean body mass (WB-EMS, 0.8 ± 1.8 % vs. aCG, -0.8 ± 2.7 %; p = 0.008) and maximum isometric strength (leg extensors, 9.8 ± 12.9 % vs. 0.2 ± 10.4 %; p = 0.003; trunk extensors, 10.1 ± 12.7 vs. -1.6 ± 8.6 %; p = 0.001). Although borderline significant for abdominal fat mass (WB-EMS, -2.9 ± 8.3 vs. aCG, 1.5 ± 10.7 %; p = 0.069), differences did not reach statistically significant levels for body fat parameters. Considering the clinical effectiveness for impacting sarcopenia and the good acceptance of this technology by this non-sportive cohort of elderly women, we conclude that for elderly subjects unable or unwilling to perform dynamic strength exercises, electromyostimulation may be a less off-putting alternative to maintain lean body mass and strength.

Long-term exercise and risk of metabolic and cardiac diseases: the erlangen fitness and prevention study.

In female subjects, ageing and the menopausal transition contribute to a rapid increase of metabolic and cardiac risk factors. Exercise may be an option to positively impact various risk factors prone to severe metabolic and cardiac diseases and events. This study was conducted to determine the long-term effect of a multipurpose exercise program on metabolic and cardiac risk scores in postmenopausal women. 137 osteopenic Caucasian females (55.4 ± 3.2 yrs), 1-8 years postmenopausal, were included in the study. Eighty-six subjects joined the exercise group (EG) and performed an intense multipurpose exercise program which was carefully supervised during the 12-year period, while 51 females maintained their habitual physical activity (CG). Main outcome measures were 10-year coronary heart disease risk (10 y CHD risk), metabolic syndrome Z-score (MetS Index), and 10-year myocardial infarction risk (10 y hard CHD risk). Significant between-group differences all in favor of the EG were determined for 10 y-CHD risk (EG: 2.65 ± 2.09% versus CG: 5.40 ± 3.30%; P = 0.001), MetS-Index (EG: -0.42 ± 1.03% versus CG: 1.61 ± 1.88; P = 0.001), and 10 y-hard-CHD risk (EG: 2.06 ± 1.17% versus CG: 3.26 ± 1.31%; P = 0.001). Although the nonrandomized design may prevent definite evidence, the intense multi-purpose exercise program determined the long-term efficacy and feasibility of an exercise program to significantly impact metabolic and cardiac risk scores in postmenopausal women. This trial is registered with ClinicalTrials.gov NCT01177761.

Effects of whole-body vibration training on different devices on bone mineral density.

PURPOSE: Whole-body vibration (WBV) is a new nonpharmacological approach to counteract osteoporosis. However, the specific vibration protocol to most effectively reduce osteoporotic risk has not been reported. In the ELVIS II (Erlangen Longitudinal Vibration Study II) trial, we determined the effect of different WBV devices on bone mineral density (BMD) and neuromuscular performance. METHODS: A total of 108 postmenopausal women (65.8 ± 3.5 yr) were randomly allocated to 1) rotational vibration training (RVT), i.e., 12.5 Hz, 12 mm, three sessions per week, for 15 min, including dynamic squat exercises; 2) vertical vibration training (VVT), i.e., 35 Hz, 1.7 mm, as above; and 3) a wellness control group (CG), i.e., two blocks of 10 low-intensity gymnastics sessions. BMD was measured at the hip and lumbar spine at baseline and after 12 months of training using dual-energy x-ray absorptiomety. Maximum isometric leg extension strength and leg power were determined using force plates. RESULTS: A BMD gain at the lumbar spine was observed in both vibration VT groups (RVT = +0.7% ± 2.2%, VVT = +0.5% ± 2.0%), which was significant compared with the CG value (-0.4% ± 2.0%) for RVT (P = 0.04) and borderline nonsignificant for VVT (P = 0.08). In the neck region, no significant treatment effect occurred. Neck BMD values tended to increase in both VT groups (RVT = +0.3% ± 2.7%, VVT = +1.1% ± 3.4%) and remained stable in CG (-0.0% ± 2.1%).Both VT groups gained maximum leg strength (RVT = +27% ± 22%, VVT = +24% ± 34%) compared with CG (+6% ± 20%, P = 0.000), whereas power measurements did not reach the level of significance (P = 0.1). CONCLUSIONS: WBV training is effective for reducing the risk for osteoporosis by increasing lumbar BMD and leg strength.

Effect of exercise and Cimicifuga racemosa (CR BNO 1055) on bone mineral density, 10-year coronary heart disease risk, and menopausal complaints: the randomized controlled Training and Cimicifuga racemosa Erlangen (TRACE) study.

OBJECTIVE: The aim of this study was to determine the effect of periodized exercise training with and without Cimicifuga racemosa (CR) on bone mineral density (BMD) and 10-year coronary heart disease (CHD) risk in early postmenopausal women. METHODS: A total of 128 women were randomly assigned to three subgroups: exercise (EG, n = 43), exercise and CR supplementation (EGCR, n = 43), and wellness control (control group [CG], n = 42). Both exercise groups performed a periodized exercise program with high-intensity-resistance/high-impact exercise dedicated to bone parameters interspersed by blocks of 10 weeks of training focusing on CHD parameters. In addition to the exercise program, the EGCR was supplemented with 40 mg/day of CR according to the specification of the manufacturer. A low-intensity exercise program of 60 minutes per week for a period of 10 weeks interspersed with 10-week blocks without exercise was performed in the CG. Primary endpoints were BMD and 10-year CHD risk proposed by Wilson. Secondary endpoints were body composition and menopausal symptoms. RESULTS: BMD at the lumbar spine was maintained in both exercise groups (EG, -0.1% +/- 2.2%, P = 0.74; EGCR, -0.4% +/- 2.4%, P = 0.40) and significantly decreased (P < 0.001) in the CG (2.0% +/- 2.0%). Both exercise groups significantly differed from the CG (P = 0.001 and 0.005 for the EG and EGCR, respectively); however, no differences between the exercise groups with and without CR was determined. Although slight increases in femoral neck BMD were determined in both exercise groups (EG, 0.5% +/- 3.0%, P = 0.36; EGCR, 0.4% +/- 3.1%, P = 0.52), a reduction was assessed in the CG (-0.6% +/- 2.7%, P = 0.29). No significant differences were determined between the groups. The 10-year CHD risk significantly increased in the EGCR (12.9% +/- 25.1%, P = 0.018) and in the CG (16.5% +/- 27.8%, P = 0.007). The EG did not show corresponding changes (-2.7% +/- 21.9%, P = 0.60). However, no significant between-group differences were observed. CONCLUSIONS: In conclusion our exercise program favorably affected bone, menopausal symptoms, lean body mass, and, to a smaller extent, 10-year CHD risk in early postmenopausal women. Adjuvant supplementation of CR did not enhance these positive effects.