scholarly journals A Randomized Placebo-Controlled Trial of Metformin for Frailty Prevention in Older Adults

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 819-820
Author(s):  
Amir Tavabi ◽  
Chen-pin Wang ◽  
Joel Michalek ◽  
Tiffany Cortes ◽  
Ethan Leonard ◽  
...  
Keyword(s):  
Older Adults ◽  
Glucose Tolerance ◽  
Muscle Biopsy ◽  
Controlled Trial ◽  
Tolerance Test ◽  
Community Dwelling ◽  
Oral Glucose ◽  
Physical Decline ◽  
Safety Assessments ◽  
Community Dwelling Older Adults

Abstract Frailty is a progressive physical decline leading to higher morbidity and mortality in older adults. Previous studies have demonstrated shared mechanisms between insulin resistance, inflammation, and frailty. The purpose of this trial is to determine whether metformin prevents frailty in non-frail, community-dwelling older adults (≥65 years) with pre-diabetes, determined by 2-hour oral glucose tolerance test (OGTT). Frail individuals (Fried criteria) and those with renal impairment (glomerular filtration rate <45 mL/min) are excluded. Eligible participants are randomized to metformin or placebo and followed for two years. The primary outcome is frailty; secondary outcomes include physical function (short physical performance battery), systemic and skeletal muscle inflammation (plasma and muscle inflammatory markers), muscle insulin signaling (muscle biopsy), insulin sensitivity (insulin clamp), glucose tolerance (OGTT), and body composition (dual-energy x-ray absorptiometry) measurements. Participants are followed every 3 months for safety assessments, every 6 months for frailty assessment and OGTT, and every 12 months for muscle biopsy. Currently, 99 participants, including 53 (53.5%) male and 91 (91.9%) white, are active (54) or have completed the study (35). At baseline, mean age was 72.3 ± 5.5 years, body mass index was 30.7 ± 5.9 kg/m2, and Hemoglobin A1c was 5.73 ± 0.37%. Mean frailty score was 0.5 ± 0.6 and the proportion of non-frail and pre-frail participants were 58.6% (n = 58) and 41.5% (n = 41), respectively. Findings of this clinical trial may have future implications for the use of metformin in older adults with pre-diabetes in order to prevent the onset of frailty.

scholarly journals Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study

2021 ◽  
Author(s):  
Nien Xiang Tou ◽  
Shiou-Liang Wee ◽  
Wei Ting Seah ◽  
Daniella Hui Min Ng ◽  
Benedict Wei Jun Pang ◽  
...  
Keyword(s):  
Older Adults ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Controlled Study ◽  
Power Training ◽  
Frail Older Adults ◽  
Frailty Status ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

AbstractTranslation of community-based functional training for older adults to reduce frailty is still lacking. We evaluated the effectiveness and implementation of a community-delivered group-based functional power training (FPT) program for frail older adults within their neighborhoods. A two-arm, multicenter assessor-blind stratified randomized controlled trial was conducted at four local senior activity centers in Singapore. Sixty-one community-dwelling older adults with low handgrip strength were randomized to intervention (IG) or control (CG) group. The IG underwent the FPT program (power and balance exercises using simple equipment) delivered by a community service provider. The 12-week program comprised 2 × 60 min sessions/week. CG continued usual activities at the centers. Functional performance, muscle strength, and frailty status were assessed at baseline and 3 months. Program implementation was evaluated using RE-AIM framework. The program was halted due to Coronavirus Disease 2019-related suspension of senior center activities. Results are reported from four centers, which completed the program. IG showed significantly greater improvement in the Short Physical Performance Battery test as compared to CG (p = 0.047). No effects were found for timed up and go test performance, muscle strength, and frailty status. The community program exhibited good reach, effectiveness, adoption, and implementation. Our study demonstrated that FPT was associated with greater improvement in physical function in pre-frail/frail participants as compared to exercise activities offered at local senior activity centers. It is a feasible intervention that can be successfully implemented for frail older adults in their neighborhoods. Trial registration ClinicalTrials.gov, NCT04438876. Registered 19 June 2020–retrospectively registered.

scholarly journals Comparison of Lateral Perturbation-Induced Step Training and Hip Muscle Strengthening Exercise on Balance and Falls in Community-Dwelling Older Adults: A Blinded Randomized Controlled Trial

2021 ◽  
Author(s):  
Mark W Rogers ◽  
Robert A Creath ◽  
Vicki Gray ◽  
Janice Abarro ◽  
Sandy McCombe Waller ◽  
...  
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Step Length ◽  
Community Dwelling ◽  
Controlled Study ◽  
Balance Performance ◽  
Muscle Strengthening ◽  
Hip Muscle ◽  
Hip Abduction ◽  
Community Dwelling Older Adults

Abstract Background This factorial, assessor-blinded, randomized, and controlled study compared the effects of perturbation-induced step training (lateral waist-pulls), hip muscle strengthening, and their combination, on balance performance, muscle strength, and prospective falls among older adults. Methods Community-dwelling older adults were randomized to 4 training groups. Induced step training (IST, n = 25) involved 43 progressive perturbations. Hip abduction strengthening (HST, n = 25) utilized progressive resistance exercises. Combined training (CMB, n = 25) included IST and HST, and the control performed seated flexibility/relaxation exercises (SFR, n = 27). The training involved 36 sessions for a period of 12 weeks. The primary outcomes were the number of recovery steps and first step length, and maximum hip abduction torque. Fall frequency during 12 months after training was determined. Results Overall, the number of recovery steps was reduced by 31% and depended upon the first step type. IST and CMB increased the rate of more stable single lateral steps pre- and post-training than HST and SFR who used more multiple crossover and sequential steps. The improved rate of lateral steps for CMB exceeded the control (CMB/SFR rate ratio 2.68). First step length was unchanged, and HST alone increased hip torque by 25%. Relative to SFR, the fall rate ratios (falls/person/year) [95% confidence interval] were CMB 0.26 [0.07–0.90], IST 0.44 [0.18–1.08], and HST 0.30 (0.10–0.91). Conclusions Balance performance through stepping was best improved by combining perturbation and strength training and not strengthening alone. The interventions reduced future falls by 56%–74% over the control. Lateral balance perturbation training may enhance traditional programs for fall prevention.

Effects of Aerobic, Resistance, or Combined Exercise Training Among Older Adults with Subjective Memory Complaints: A Randomized Controlled Trial

2021 ◽  
pp. 1-17
Author(s):  
Taeko Makino ◽  
Hiroyuki Umegaki ◽  
Masahiko Ando ◽  
Xian Wu Cheng ◽  
Koji Ishida ◽  
...  
Keyword(s):  
Older Adults ◽  
Exercise Training ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Control Group ◽  
Subjective Memory ◽  
Logical Memory ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

Background: Physical exercise is suggested to be effective for preventing cognitive decline in older adults, but the relative efficacy of different types of exercise have yet to be clarified. Objective: This single-blinded randomized controlled trial was designed to investigate the differential effects of aerobic exercise training (AT), resistance exercise training (RT), and combined exercise training (CT) on cognition in older adults with subjective memory complaints (SMC). Methods: Community-dwelling older adults with SMC (n = 415; mean age = 72.3 years old) were randomly assigned to one of the four groups: AT, RT, CT, or control group. The study consisted of two phases: a 26-week intervention and a 26-week follow-up. The participants were evaluated at baseline, 26 weeks (postintervention), and 52 weeks (follow-up). The primary outcome of this study was memory function, which was assessed using the Logical Memory II subtest of the Wechsler Memory Scale-Revised (WMS-R) score. The secondary outcomes included global cognitive function, verbal fluency, working memory, processing speed, and executive functions. Results: Intention-to-treat analysis by a mixed-effect model repeated measure showed that the AT group had significantly improved performance on the WMS-R Logical Memory II test (2.74 [1.82–3.66] points) than the control group (1.36 [0.44–2.28] points) at the postintervention assessment (p = 0.037). The effect was more pronounced in those without amnesia than those with amnesia. No significant improvement was observed in the RT and CT groups. Conclusion: This study suggests that AT intervention can improve delayed memory in community-dwelling older adults, particularly in individuals without objective memory decline.

scholarly journals Baseline Characteristics of Participants in a Randomized Controlled Trial of Metformin for Frailty Prevention

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 130-131
Author(s):  
Tiffany Cortes ◽  
Nicolas Musi ◽  
Chen-pin Wang ◽  
Joel Michalek ◽  
Sara Espinoza
Keyword(s):  
Randomized Controlled Trial ◽  
Glucose Tolerance ◽  
Physical Performance ◽  
Controlled Trial ◽  
Tolerance Test ◽  
Oral Glucose ◽  
Double Blind ◽  
Randomized Controlled ◽  
Insulin Clamp ◽  
And Function

Abstract We are conducting a double-blind, randomized controlled trial of metformin for frailty prevention. Participants are adults aged 65+ years with pre-diabetes assessed by 2-hour oral glucose tolerance test (OGTT). Those who are frail (Fried criteria) are excluded. Participants are randomized to metformin (maximum dose of 2,000 mg/day) vs. placebo and followed for 2 years. The primary outcome is frailty (category and score); secondary outcomes are physical performance and function (short physical performance battery, 6-minute walk, lower extremity strength), systemic and skeletal muscle tissue inflammation, muscle insulin signaling, insulin sensitivity (insulin clamp), glucose tolerance (OGTT), and body composition (dual-energy x-ray absorptiometry). Safety assessments occur every 3 months; frailty, systemic inflammation, and OGTT are assessed at baseline and every 6 months, and insulin clamp with muscle biopsies are assessed at baseline and every 12 months. To date, 85 subjects have been randomized; 120 completers are planned. Mean age is 72.8 ± 5.7 years, 55.3% are male, and 43.5% were Hispanic. Mean BMI is 30.2±5.8 kg/m2, waist circumference is 104.4 ±15.5 cm, fasting glucose is 102.3 ± 10.0 mg/dL, Hemoglobin A1c is 5.8 ±0.3, and glucose at 2 hours during OGTT is 167.3 ± 17.8 mg/dL. Metformin is being examined in this study as a potential therapeutic agent to prevent frailty in older adults with pre-diabetes. Findings from this trial may have future implications for the screening and potential treatment of pre-diabetes in older patients with metformin for the prevention of frailty.

scholarly journals The postcard intervention against depression among community-dwelling older adults: study protocol for a randomized controlled trial

Trials ◽  
2013 ◽  
Vol 14 (1) ◽  
pp. 202 ◽  
Author(s):  
Hissei Imai ◽  
Toshiaki A Furukawa ◽  
Kiyohito Okumiya ◽  
Taizo Wada ◽  
Eriko Fukutomi ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

scholarly journals Randomized controlled trial to evaluate a prevention program for frail community-dwelling older adults: a D-SCOPE protocol

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Deborah Lambotte ◽  
Liesbeth De Donder ◽  
Ellen E. De Roeck ◽  
Lieve J. Hoeyberghs ◽  
Anne van der Vorst ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Prevention Program ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

Use and effect of web-based embodied conversational agents for improving eating behavior and decreasing loneliness among community-dwelling older adults: A randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Lean L. Kramer ◽  
Lex van Velsen ◽  
Jenna L. Clark ◽  
Bob C. Mulder ◽  
Emely de Vet
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Eating Behavior ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Embodied Conversational Agents ◽  
Conversational Agents ◽  
Web Based ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

BACKGROUND Embodied conversational agents (ECAs) have been proposed as a promising interaction modality for the delivery of programs focused on promoting lifestyle changes. However, it is not understood which factors influence use of an ECA and their health effects. OBJECTIVE We aim to (1) identify whether ECAs can persuade community-dwelling older adults to change their dietary behavior and whether ECAs use can decrease loneliness, (2) test these pathways to effects, and (3) understand the use of an ECA. METHODS The web-based eHealth app PACO is a fully automated 8-week intervention in which 2 ECAs engage older adults in dialogue to motivate them to change their dietary behavior and decrease their loneliness. PACO was developed via a human-centered and stakeholder-inclusive design approach and incorporates Self-determination Theory and various behavior change techniques For this study, an unblinded web-based randomized controlled trial was conducted. Participants were recruited via social media, an online panel, flyers and advertorials. The intervention group received access to the PACO service for eight weeks. The waitlist group received PACO after waiting for four weeks. The primary outcomes, eating behavior and loneliness, were assessed via self-assesed online questionnaires at intake, waitlist, after 4 weeks, and after eight weeks. In addition, the primary outcome—use—was assessed via data logs. Secondary outcomes were measured at the same times, via questionnaires or an optional interview. RESULTS In total, 32 participants completed the intervention. We found a significant correlation between use in minutes on the one hand, and perceived usefulness (r = .39, P =.030) and enjoyment on the other (r = .38, P = .032). However, these did not predict use in the full regression model (F(2,29) = 1.98, P = .16, R2 = .12). Additionally, PACO use did not lead to improvements in eating behavior (χ2(2) = .34, = .85) or a decrease in loneliness (χ2(2) = .02, = .99). CONCLUSIONS Our study did not provide any concluding evidence about factors that are linked to the use or health effects of ECAs. Future service design could benefit from either creating a functional design catered towards the predominant stage of the targeted population, or by personalizing the service based on an intake in which the end-user’s stage is determined. CLINICALTRIAL ClinicalTrials.gov NCT04510883; https://clinicaltrials.gov/ct2/show/NCT04510883 INTERNATIONAL REGISTERED REPORT RR2-10.2196/22186

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