CAN AN INTERVENTION WITH TESTOSTERONE AND NUTRITIONAL SUPPLEMENT IMPROVE THE FRAILTY LEVEL OF UNDER-NOURISHED OLDER PEOPLE?

Objective: To examine whether a testosterone and a high calorie nutritional supplement intervention can reduce frailty scores in undernourished older people using multiple frailty tools. Design: Randomized controlled trial. Setting/Participants: 53 community-dwelling, undernourished men and women aged >65 years from South Australia, Victoria and New South Wales. Intervention: Intervention group received oral testosterone undecanoate and a high calorie supplement (2108-2416 kJ/day) whereas the control group received placebo testosterone and low calorie supplement (142-191 kJ/day). Measurements: Frailty was operationalized using three frailty indices (FI-lab, FI-self-report, FI-combined) and the frailty phenotype. Results: There were no significant differences in changes in frailty scores at either 6 or 12 months follow up between the two treatment groups for all scales. Participants at the intervention group were 4.8 times more likely to improve their FI-combined score at both time points compared to the placebo group. Conclusion: A testosterone and a high calorie nutritional supplement intervention did not improve the frailty levels of under-nourished older people. Even so, when frailty was measured using a frailty index combining self-reported and lab data we found that participants who received the intervention were more likely to show persistent improvement in their frailty scores.

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The feasibility and effects of virtual-reality motor-cognitive training in community-dwelling older people with cognitive frailty: A pilot randomized controlled trial (Preprint)

10.2196/preprints.28400 ◽

2021 ◽

Author(s):

Rick Yiu Cho Kwan ◽

Justina Yat Wa Liu ◽

Kenneth Nai Kuen Fong ◽

Harry Qin ◽

Philip Kwok-Yuen Leung ◽

...

Keyword(s):

Cognitive Function ◽

Older People ◽

Cognitive Training ◽

Walking Speed ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Physical Frailty ◽

Cognitive Frailty

BACKGROUND Cognitive frailty refers to the coexistence of physical frailty and cognitive impairment and is associated with many adverse health outcomes. While cognitive frailty is prevalent in older people, motor-cognitive training is effective at enhancing cognitive and physical function We propose a virtual reality (VR) simultaneous motor-cognitive training program, which allows older people to practice performing daily activities in a virtual space mimicking real environments. OBJECTIVE We aimed 1) to explore the feasibility of offering VR simultaneous motor-cognitive training to older people with cognitive frailty and 2) to compare its effects with an existing motor-cognitive training program in the community on the cognitive function and physical function of older people with cognitive frailty. METHODS A two-arm (1:1), assessor-blinded, parallel design, randomized controlled trial (RCT) was employed. The eligibility criteria for participants were: 1) age≥60 years, 2) community dwelling, and 3) with cognitive frailty. Those in the intervention group received cognitive training (i.e., cognitive games) and motor training (i.e., cycling on an ergometer) simultaneously on a VR platform, mimicking the daily living activities of older people. Those in the control group received cognitive training (i.e., cognitive games) on tablet computers and motor training (i.e., cycling on the ergometer) sequentially on a non-VR platform. Both groups received a 30-minute session twice a week for 8 weeks. Feasibility was measured by adherence, adverse outcomes, and successful learning. The outcomes were cognitive function, physical frailty level, and walking speed. RESULTS Seventeen participants were recruited and randomized into either the control group (n=8) or intervention group (n=9). At baseline, the median age was 74.0 years (IQR=9.5) and the median MoCA score was 20.0 (IQR=4.0). No significant between-group differences were found except in the number of chronic illnesses (P=0.043). At post-intervention, the intervention group (Z=-2.673, P=0.008) showed a significantly larger improvement in cognitive function than the control group (Z=-1.187, P=0.235). The reduction in physical frailty in the intervention group (Z=-1.730, P=0.084) was similar to that in the control group (Z=-1.890, P=0.059). The TUG-measured improvement in walking speed was moderate in the intervention group (Z=-0.159, P=0.110), and greater in the control group (Z=-2.521, P=0.012). The recruitment rate was acceptable (17/33, 51.5%). Both groups had a 100% attendance rate. The intervention group had a higher completion rate than the control group. Training was terminated for one participant (1/9, 11.1%) due to minimal VR sickness (VRSQ=18.3/100). Two participants (2/8, 25%) in the control group withdrew due to moderate leg pain. No injuries were observed in both groups. CONCLUSIONS This study provides preliminary evidence that the VR simultaneous motor-cognitive training group experienced greater improvement in cognitive function than the control group, and reduced frailty and improved walking speed. VR training is feasible and safe for older people with cognitive frailty. CLINICALTRIAL ClinicalTrials.gov NCT0446726

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Can Muscle Mass Be Maintained with A Simple Resistance Intervention in the Older People? A Cluster Randomized Controlled Trial in Thailand

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph19010140 ◽

2021 ◽

Vol 19 (1) ◽

pp. 140

Author(s):

Bumnet Saengrut ◽

Takeshi Yoda ◽

Yumi Kimura ◽

Yasuko Ishimoto ◽

Rujee Rattanasathien ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Older People ◽

Muscle Mass ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Randomized Controlled ◽

Physiological Outcomes

The aging population is rapidly increasing worldwide. Sarcopenia is a common and important health problem among older people. The prevalence of sarcopenia among older Thai adults is increasing. Exercise intervention for sarcopenia prevention may significantly improve muscle strength, body balance, and muscle mass. Therefore, this study aimed to investigate the effects of a simple resistance intervention (SRI) program in preventing sarcopenia on physiological outcomes among community-dwelling older Thai adults. This study was a 12-week randomized controlled trial, which included 80 community-dwelling older adults in Chiang Mai, Thailand, who were randomly assigned into control (40 participants who performed usual exercise) and intervention (40 participants who performed the SRI program) groups. The SRI program was a home-based program consisting of 30 min of resistance exercise three times/week for 12 weeks, health education on sarcopenia. After 12 weeks, all physiological outcomes were measured and were significantly improved in the intervention group compared with baseline; hand grip, skeletal muscle mass index, and walking speed were significantly improved in the intervention group compared with the control group. Based on our results, the SRI program may prevent muscle weakness in community-dwelling older people in Thailand.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Increasing Life-Space Mobility in Community-Dwelling Older Persons With Cognitive Impairment Following Rehabilitation: A Randomized Controlled Trial

The Journals of Gerontology Series A ◽

10.1093/gerona/glaa254 ◽

2020 ◽

Author(s):

Phoebe Ullrich ◽

Christian Werner ◽

Martin Bongartz ◽

Tobias Eckert ◽

Bastian Abel ◽

...

Keyword(s):

Cognitive Impairment ◽

Older Persons ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Life Space ◽

Home Based ◽

Independent Life

Abstract Background Community-dwelling older persons with cognitive impairment (CI) following discharge from geriatric rehabilitation are at high risk of losing life-space mobility (LSM). Interventions to improve their LSM are, however, still lacking. The aim of this study was to evaluate the effects of a CI-specific, home-based physical training and activity promotion program on LSM. Methods Older persons with mild-to-moderate CI (Mini-Mental State Examination: 17–26 points) discharged home from rehabilitation were included in this double-blinded, randomized, placebo-controlled trial with a 12-week intervention period and 12-week follow-up period. The intervention group received a CI-specific, home-based strength, balance, and walking training supported by tailored motivational strategies. The control group received a placebo activity. LSM was evaluated by the Life-Space Assessment in Persons with Cognitive Impairment, including a composite score for LSM and 3 subscores for maximal, equipment-assisted, and independent life space. Mixed-model repeated-measures analyses were used. Results One hundred eighteen participants (82.3 ± 6.0 years) with CI (Mini-Mental State Examination: 23.3 ± 2.4) were randomized. After the intervention, the home-based training program resulted in a significant benefit in the Life-Space Assessment in Persons with Cognitive Impairment composite scores (b = 8.15; 95% confidence interval: 2.89–13.41; p = .003) and independent life-space subscores (b = 0.39; 95% confidence interval: 0.00–0.78; p = .048) in the intervention group (n = 63) compared to control group (n = 55). Other subscores and follow-up results were not significantly different. Conclusions The home-based training program improved LSM and independent life space significantly in this vulnerable population. Effects were not sustained over the follow-up. The program may represent a model for improved transition from rehabilitation to the community to prevent high risk of LSM restriction.

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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86 Developing the Adapted Lifestyle - Integrated Functional Exercise Programme in Thai Context (TLIFE) to Prevent Falls among Older Adults in Thailand: A Mixed Methods Study

Age and Ageing ◽

10.1093/ageing/afz164.86 ◽

2019 ◽

Vol 48 (Supplement_4) ◽

pp. iv18-iv27

Author(s):

Sasiporn Ounjaichon ◽

Chris Todd ◽

Emma Stanmore ◽

Elisabeth Boulton

Keyword(s):

Older Adults ◽

Randomised Controlled Trial ◽

Retention Rate ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Community Dwelling ◽

Control Group ◽

Functional Exercise ◽

Randomised Controlled

Abstract Introduction Falls are the leading cause of injuries in older Thai adults. There is a need to develop a fall prevention exercise programme to encourage participation and adherence. The adapted Lifestyle-integrated Functional Exercise (aLiFE) programme may be suitable by integrating exercise into daily routines as opposed to attending an exercise class. This study aimed to explore the acceptability and feasibility of the aLiFE programme in Thai context (TLiFE) among older Thai adults. Methods Based on the findings of a prior qualitative study, a feasibility randomised controlled trial (RCT) of TLiFE was conducted among community-dwelling older adults, comparing the TLiFE intervention group with a usual care control group. Outcome measures were analysed at baseline, 3 months, and after 6 months of the intervention. Results We recruited a total of 72 older adults into the RCT, randomised to TLiFE (n=36) and control (n=36). The retention rate at 6 months was 91.7%. Attendance in the intervention group (3 home visits and 4 follow-up calls) was 82.9%. There were no differences in fall incidence between the groups. The acceptability survey reveals TLiFE is easy to perform in daily life, safe, and useful. No adverse events were reported. Conclusion The TLiFE programme appears to be acceptable and feasible to deliver to community-dwelling older Thai adults. This feasibility study was not powered to detect a difference between groups. A further fully powered definitive randomised controlled trial of TLiFE is needed to evaluate long-term outcomes and cost-effectiveness before it is integrated within the healthcare system in Thailand.

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Leucine-Enriched Protein Supplementation Increases Lean Body Mass in Healthy Korean Adults Aged 50 Years and Older: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽

10.3390/nu12061816 ◽

2020 ◽

Vol 12 (6) ◽

pp. 1816

Author(s):

Yeji Kang ◽

Namhee Kim ◽

Yong Jun Choi ◽

Yunhwan Lee ◽

Jihye Yun ◽

...

Keyword(s):

Lean Body Mass ◽

Body Mass ◽

Controlled Trial ◽

Intervention Group ◽

Dropout Rate ◽

Protein Supplementation ◽

Community Dwelling ◽

Control Group ◽

Middle Aged ◽

Middle Aged Adults

Early prevention of sarcopenia could be an important strategy for muscle retention, but most studies have focused on subjects aged 65 or older. Therefore, in this study we investigated the effects of leucine-enriched protein supplementation on muscle condition in a sample including late middle-aged adults. A 12-week intervention was performed for 120 healthy community-dwelling adults by providing either leucine-enriched protein supplement [protein 20g(casein 50%+ whey 40%+ soy 10%, total leucine 3000 mg), vitamin D 800IU(20 ug), calcium 300 mg, fat 1.1 g, carbohydrate 2.5 g] or isocaloric carbohydrate supplement twice per day. Appendicular skeletal muscle mass (ASM) and lean body mass (LBM) were measured by dual-energy X-ray absorptiometry. A total of 111 participants completed the study, with a dropout rate of 9.2%. LBM normalized by body weight (LBM/Wt) was significantly increased (p < 0.001) in the intervention group (0 wk: 63.38 ± 0.85 vs. 12 wk 63.68 ± 0.83 in the intervention group; 0 wk: 63.85 ± 0.82 vs. 12 wk: 63.29 ± 0.81 in the control group). In subgroup analyses, significant differences remained only in subjects between 50 and 64 years of age. We concluded that leucine-enriched protein supplementation can have beneficial effects by preventing muscle loss, mainly for late middle-aged adults.

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Early intervention in panic: pragmatic randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.109.072504 ◽

2010 ◽

Vol 196 (4) ◽

pp. 326-331 ◽

Cited By ~ 24

Author(s):

Peter Meulenbeek ◽

Godelief Willemse ◽

Filip Smit ◽

Anton van Balkom ◽

Philip Spinhoven ◽

...

Keyword(s):

Early Intervention ◽

Panic Disorder ◽

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Self Report ◽

Control Group ◽

Cognitive Behavioural ◽

Clinically Significant ◽

Randomised Controlled

BackgroundMany people suffer from subthreshold and mild panic disorder and are at risk of developing more severe panic disorder.AimsThis study (trial registration: ISRCTN33407455) was conducted to evaluate the effectiveness of an early group intervention based on cognitive–behavioural principles to reduce panic disorder symptomatology.MethodParticipants with subthreshold or mild panic disorder were recruited from the general population and randomised to the intervention (n = 109) or a waiting-list control group (n = 108). The course was offered by 17 community mental health centres.ResultsIn the early intervention group, 43/109 (39%) participants presented with a clinically significant change on the Panic Disorder Severity Scale–Self Report (PDSS–SR) v. 17/108 (16%) in the control group (odds ratio (OR) for favourable treatment response 3.49, 95% CI 1.77–6.88, P = 0.001). The course also had a positive effect on DSM–IV panic disorder status (OR = 1.96, 95% CI=1.05–3.66, P = 0.037). The PDSS–SR symptom reduction was also substantial (between-group standardised mean difference of 0.68). The effects were maintained at 6-month follow-up.ConclusionsPeople presenting with subthreshold and mild panic disorder benefit from this brief intervention.

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The efficacy of a resilience-enhancement program for mothers in Japan based on emotion regulation: study protocol for a randomized controlled trial

BMC Psychology ◽

10.1186/s40359-019-0344-6 ◽

2019 ◽

Vol 7 (1) ◽

Cited By ~ 1

Author(s):

Hiromi Tobe ◽

Mariko Sakka ◽

Kiyoko Kamibeppu

Keyword(s):

Emotion Regulation ◽

Child Maltreatment ◽

Parental Stress ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Self Report ◽

Baseline Survey ◽

Control Group ◽

Post Intervention

Abstract Background The demands of daily life often cause mothers high levels of distress and other negative emotions. Anger, including harsh verbal discipline, has been linked to child maltreatment, with long-term adverse effects on a child’s well-being. It is critically important to teach mothers stress management and emotion regulation in addition to parenting skills, but this is yet to be conducted in a formalized manner. Strengthening the multiple protective factors that constitute resilience helps reduce distress. The aim of this study is to evaluate the efficacy of a resilience-enhancement program for mothers. Methods We designed a two-arm, parallel, randomized trial with an active control. Mothers and their partners with children between three and six years old will be recruited. Following an online baseline survey, 140 mothers will be randomly allocated to either an intervention or control group. Self-report assessment will be conducted online post-intervention and at a two-month follow-up. The control group will participate in a serious of group discussions. The intervention group will participate in four bi-weekly 120-min sessions of a Cognitive Behavior Therapy-based program designed to enhance resilience, focusing on emotion regulation through cognitive reappraisal. Participants will be encouraged to apply and share the skills they acquire with their partner and children at home. Partners will also be assessed to explore their indirect influence from the mothers. Intention-to-treat analysis will be conducted and the two groups will be compared, applying covariate analysis. The primary outcome of the intervention is improved resilience. Secondary outcomes include improved anger control, self-esteem, cognition of children’s misbehavior, and reduced parental stress. Discussion To the best of our knowledge, this study will evaluate the first resilience-enhancement program focused on emotion regulation for mothers in Japan. It will contribute to the existing body of knowledge on building emotional resilience. If the program is found to be effective, it will provide an alternative means to enhance mothers’ resilience against stress and improve their ability to regulate emotion. In so doing, it will offer a way to prevent child maltreatment and protect the mental health of children and families. Trial registration UMIN000027232, May 3, 2017.

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Mindfulness-based programme for residents: study protocol of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-035025 ◽

2020 ◽

Vol 10 (3) ◽

pp. e035025

Author(s):

Vanessa Marie-Jane Aeschbach ◽

Johannes Caspar Fendel ◽

Anja Simone Göritz ◽

Stefan Schmidt

Keyword(s):

Mental Distress ◽

Medical Center ◽

Controlled Trial ◽

Intervention Group ◽

Maintenance Phase ◽

Self Report ◽

Physiological Data ◽

Control Group ◽

Daily Routine ◽

Randomised Controlled

IntroductionResidency is a stressful phase associated with high prevalence of mental distress. Besides impaired personal health, mental distress in residents has an impact on the quality of patient care and produces economic costs. Therefore, there is demand for interventions that improve resident physicians’ mental health. The aim of the present study is to examine the effects of a mindfulness-based intervention that has been tailored to residents’ needs. Specifically, mindfulness has been supplemented by a focus on the concept of Muße.Methods and analysisThis study applies a randomised controlled multimethod design. Residents assigned to the intervention group will participate in an 8-week mindfulness course followed by a 4-month maintenance phase, whereas residents assigned to the control group will read text-based information about mindfulness on a weekly basis for the duration of 8 weeks. The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents’ self-care as well as on building empathic relationships. Participants will be assessed before, directly after the intervention, after the maintenance phase as well as at follow-up 6 months after the intervention group completes the intervention. Assessments will consist of self-report measures, physiological data, qualitative interviews, third-party reports as well as implicit and projective measures and will focus on both psychopathology and salutogenesis. The primary outcome will be burnout. Data will be analysed using linear mixed modelling.Ethics and disseminationThe study was approved by the ethics committee of the Medical Center - University of Freiburg and is funded by the German Research Foundation as part of the interdisciplinary Collaborative Research Center ‘SFB Muße 1015’. The results of this study will be published in scientific journals and disseminated through the study’s website, and conferences.Trial registration numberDRKS00014015.

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