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COMbined Exercise Trial (COMET) to improve cognition in older adults: Rationale and methods.

ABSTRACT: Substantial evidence suggests physical exercise may sustain cognitive function and perhaps prevent Alzheimer's Disease (1, 2). Current public health recommendations call for older adults to do at least 150 min a week of aerobic exercise (e.g. walking) and twice a week resistance exercise (e.g. weight lifting) for physical health. Yet, much remains unknown about how these exercise modalities support brain health independently or in combination. The COMbined Exercise Trial (COMET) is designed to test the combined and independent effects of aerobic and resistance training specifically focusing on exercise-related changes in 1) cognitive performance, 2) regional brain volume, 3) physical function, and 4) blood-based factors. To explore these questions, we will enroll 280 cognitively normal older adults, age 65-80 years, into a 52-week community-based exercise program. Participants will be randomized into one of four arms: 1) flexibility/toning- control 2) 150 min of aerobic exercise only, 3) progressive resistance training only, or 4) combined aerobic and progressive resistance training. Outcomes assessed include a comprehensive cognitive battery, blood biomarkers, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and battery of psychosocial questionnaires is assessed at baseline, 6 and 12-months. COMET will provide rigorous randomized controlled trial data to understand the effects of the most common exercise modalities, and their combination (i.e., the standard public health recommendation), on brain health.

SUBMITTER: Szabo-Reed A

PROVIDER: S-EPMC9354507 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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COMbined Exercise Trial (COMET) to improve cognition in older adults: Rationale and methods.

Szabo-Reed Amanda A Clutton Jonathan J White Sydney S Van Sciver Angela A White Dreu D Morris Jill J Martin Laura L Lepping Rebecca R Shaw Ashley A Puchalt Jaime Perales JP Montgomery Robert R Mahnken Jonathan J Washburn Richard R Burns Jeffrey J Vidoni Eric D ED

Contemporary clinical trials 20220527

Substantial evidence suggests physical exercise may sustain cognitive function and perhaps prevent Alzheimer's Disease (1, 2). Current public health recommendations call for older adults to do at least 150 min a week of aerobic exercise (e.g. walking) and twice a week resistance exercise (e.g. weight lifting) for physical health. Yet, much remains unknown about how these exercise modalities support brain health independently or in combination. The COMbined Exercise Trial (COMET) is designed to t ...[more]

PMID: 35636733

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Project description:Background and objectivesMobility limitation is common and has been linked to high energetic requirements of daily activities, including walking. The study objective was to determine whether two separate forms of exercise could reduce the energy cost of walking and secondary outcomes related to activity and participation domains among older adults with mobility limitation.Research design and methodsCommunity-dwelling older adults with self-reported mobility limitation (n = 72) were randomized to 12 weeks of twice-weekly, group-based, instructor-led timing and coordination, aerobic walking, or stretching and relaxation (active control) programs. The primary outcome was the energy cost of walking (mL O2/kg/m), assessed by a 5-minute treadmill walking test (0.8 m/s). Secondary outcomes were fatigability, physical activity, endurance, physical function, and life-space. Baseline-adjusted ANCOVAs were used to determine mean differences between exercise and control groups at 12 and 24 weeks.ResultsExercise session attendance was high: 86% for timing and coordination, 81% for aerobic walking, and 90% for stretching and relaxation. At 12 weeks, timing and coordination reduced the mean energy cost of walking by 15% versus stretching and relaxation (p = .008). Among those with high baseline cost, timing and coordination reduced mean energy cost by 20% versus stretching and relaxation (p = .055). Reductions were sustained at 24 weeks. Aerobic walking had no effect on the energy cost of walking at 12 or 24 weeks. At 12 weeks, there was a trend toward faster gait speed (by 0.1 m/s) in timing and coordination versus stretching and relaxation (p = .074). Fatigability, physical activity, endurance, physical function, and life-space did not change with timing and coordination or aerobic walking versus stretching and relaxation at 12 or 24 weeks.Discussion and implicationsTwelve weeks of timing and coordination, but not aerobic walking, reduced the energy cost of walking among older adults with mobility limitation, particularly among those with high baseline energy cost; reductions in energy cost were sustained following training cessation. Timing and coordination also led to a trend toward faster gait speed.

Project description:ImportanceExercise, cognitive training, and vitamin D may enhance cognition in older adults with mild cognitive impairment (MCI).ObjectiveTo determine whether aerobic-resistance exercises would improve cognition relative to an active control and if a multidomain intervention including exercises, computerized cognitive training, and vitamin D supplementation would show greater improvements than exercise alone.Design, setting, and participantsThis randomized clinical trial (the SYNERGIC Study) was a multisite, double-masked, fractional factorial trial that evaluated the effects of aerobic-resistance exercise, computerized cognitive training, and vitamin D on cognition. Eligible participants were between ages 65 and 84 years with MCI enrolled from September 19, 2016, to April 7, 2020. Data were analyzed from February 2021 to December 2022.InterventionsParticipants were randomized to 5 study arms and treated for 20 weeks: arm 1 (multidomain intervention with exercise, cognitive training, and vitamin D), arm 2 (exercise, cognitive training, and placebo vitamin D), arm 3 (exercise, sham cognitive training, and vitamin D), arm 4 (exercise, sham cognitive training, and placebo vitamin D), and arm 5 (control group with balance-toning exercise, sham cognitive training, and placebo vitamin D). The vitamin D regimen was a 10 000 IU dose 3 times weekly.Main outcomes and measuresPrimary outcomes were changes in ADAS-Cog-13 and Plus variant at 6 months.ResultsAmong 175 randomized participants (mean [SD] age, 73.1 [6.6] years; 86 [49.1%] women), 144 (82%) completed the intervention and 133 (76%) completed the follow-up (month 12). At 6 months, all active arms (ie, arms 1 through 4) with aerobic-resistance exercise regardless of the addition of cognitive training or vitamin D, improved ADAS-Cog-13 when compared with control (mean difference, -1.79 points; 95% CI, -3.27 to -0.31 points; P = .02; d = 0.64). Compared with exercise alone (arms 3 and 4), exercise and cognitive training (arms 1 and 2) improved the ADAS-Cog-13 (mean difference, -1.45 points; 95% CI, -2.70 to -0.21 points; P = .02; d = 0.39). No significant improvement was found with vitamin D. Finally, the multidomain intervention (arm 1) improved the ADAS-Cog-13 score significantly compared with control (mean difference, -2.64 points; 95% CI, -4.42 to -0.80 points; P = .005; d = 0.71). Changes in ADAS-Cog-Plus were not significant.Conclusions and relevanceIn this clinical trial, older adults with MCI receiving aerobic-resistance exercises with sequential computerized cognitive training significantly improved cognition, although some results were inconsistent. Vitamin D supplementation had no effect. Our findings suggest that this multidomain intervention may improve cognition and potentially delay dementia onset in MCI.Trial registrationClinicalTrials.gov Identifier: NCT02808676.

Project description:ObjectiveThe objective of this study was to investigate whether a 5-year exercise intervention and change in peak oxygen uptake ([Formula: see text]) is associated with cognitive function in older adults.MethodsNine hundred and forty-five participants (48% women, mean age at study end 78.2 ± 2.02 years) from the Generation 100 Study were randomized 2:1:1 to a control group, moderate-intensity continuous training or high-intensity interval training twice weekly for 5 years. Peak oxygen uptake was measured using ergospirometry at baseline and after 5 years. Global cognition and mild cognitive impairment (MCI) were assessed with the Montreal Cognitive Assessment scale (MoCA) after 5 years.ResultsCompared to the control group, the combined moderate-intensity continuous training plus high-intensity interval training (ExComb) group did not have significantly different cognitive scores (beta value 0.26, 95% confidence interval [CI] - 0.17, 0.69) or odds of MCI (odds ratio 0.86, 95% CI 0.66, 1.13). Men in the ExComb group had 0.80 points higher MoCA (95% CI 0.21, 1.40) and 32% lower odds of MCI compared with male controls (95% CI 0.47, 0.99), with no such findings in women. In the total sample, each 1 metabolic equivalent of task increase in [Formula: see text] corresponded to 0.46 points higher MoCA (95% CI 0.25, 0.67) and 27% lower odds of MCI (95% CI 0.63, 0.85). Compared to [Formula: see text] stable, participants whose [Formula: see text] increased did not have significantly different cognitive scores (beta value 0.24, CI - 0.68, 1.15) or odds of MCI (odds ratio 0.70, 95% CI 0.36, 1.34), whereas participants whose [Formula: see text] decreased had 0.64 points lower MoCA (95% CI - 1.15, - 0.14) and 35% higher odds of MCI (95% CI 0.98, 1.87).ConclusionsOverall, exercise was not significantly associated with cognition among older adults. However, maintaining or increasing [Formula: see text] appeared to benefit cognition.Clinical trial registrationClinicalTrials.gov NCT01666340.

Project description:IntroductionRegular physical activity lowers risk for cognitive decline and neurodegenerative disorders. Older African Americans (AAs) have been underrepresented in trials that increased physical activity to improve cognitive outcomes.Methods56 sedentary, older, cognitively healthy AAs (avg. 69.2 ± 3.4 yrs. old) were randomized in 1:1 ratio into either a 12-week successful aging group (SAG) or a 12-week physical activity group (PAG). Participants in SAG attended weekly 60-min educational sessions in which healthy aging topics were discussed. Participants in PAG attended supervised physical activity sessions twice per week at local YMCAs (90-120 min/week) and were prescribed 2-3 days per week of home-based activity. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assessed cognitive function. ANCOVA models compared mean 12-week change in global cognition and subdomain scores between groups with secondary analyses for sex differences. Effect sizes for RBANS were calculated.ResultsThe RBANS global cognition score (SAG Est. 5.6 ± 1.8, effect size = 0.37, p = 0.003) and several subdomain scores (one-sample T tests, all p < 0.05) increased significantly within the SAG. Scores for global cognition increased more in SAG than in PAG (Change Estimate, PAG minus SAG: -4.6 ± 2.5 points, effect size = 0.31) at a trend level (p = 0.072). SAG females increased their global cognition score more than PAG females and more than males in either PAG or SAG (all p < 0.035).DiscussionA 12-week physical activity intervention (PAG) did not improve cognitive functioning among older AAs but a comparator healthy aging education program did. Inadequate physical activity dosage or duration, SAG members acting on health-related information from educational sessions, and/or social stimulation within the SAG may have contributed to these results. Future studies should combine socially engaging activities with vigorous physical activity for cognitive enhancement among cognitively healthy older African Americans.Clinical trial registrationwww.ClinicalTrials.gov, identifier NCT03474302.

Project description:BackgroundFrailty leads to reduced physical activity can cause increased fall risk. This contributes to accelerated aging processes, leading to adverse health outcomes and reduced quality of life. We have developed and piloted the design, usability, safety, and feasibility of a gaming-based cognitive-motor (CogXergaming) tele-exercise protocol in prefrail older adults.ObjectiveThis pilot randomized control trial tested preliminary feasibility and effectiveness of the CogXergaming telehealth protocol for improving physical function.MethodsCommunity-dwelling, prefrail older adults were randomly assigned to CogXergaming (n=13) or a control group (n=14). The CogXergaming group received supervised tele-exercises in a gaming format for 6 weeks (3 sessions per week) comprising 18 sessions lasting 90 minutes each. Control group participants participated in a Matter of Balance (MOB), an 8-week, once-a-week structured 90-minute tele-session that has been shown to reduce the fear of falling and increase physical activity. Feasibility of training was obtained by computing the median duration of training sessions for the CogXergaming group. Effectiveness was assessed using dynamic balance control (Four Square Step Test), subjective self-efficacy (Activities-Specific Balance Confidence scale), gait function (Tinetti Performance Oriented Mobility Assessment), muscle strength (30-second chair stand test), and endurance (2-minute step in-place test).ResultsOf the 45 participants enrolled in the study, 4 participants from CogXergaming group and 5 from MOB group lost contact after signing the consent form and did not receive their respective intervention. Eighteen participants were randomized to each group. In the CogXergaming group, 15 (83%) completed the intervention, with 3 (16%) dropping out in the first week. In the MOB group, 16 (88%) completed the program, with 2 (11%) withdrawing during the first week. In addition, there was a significant time group interaction for Four Square Step Test (F1,21=5.55, P=.03), Tinetti Performance Oriented Mobility Assessment (F1,25=4.16, P=.05), and 30-second chair stand test (F1,21=5.06, P=.03), with a significant improvement in these measures for the CogXergaming group post training, compared with no change observed in the MOB group.ConclusionsThese pilot findings indicate that CogXergaming is feasible and applicable in prefrail older adults. Such game-based protocols can be beneficial in improving physical function among community-dwelling, prefrail older adults, however, the efficacy of such training requires further investigation.Trial registrationClinicalTrials.gov NCT04534686; https://clinicaltrials.gov/study/NCT04534686.

Dataset Information

COMbined Exercise Trial (COMET) to improve cognition in older adults: Rationale and methods.

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COMbined Exercise Trial (COMET) to improve cognition in older adults: Rationale and methods.

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