Dataset Information

Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial.

ABSTRACT:

Introduction

Effective strategies to recruit older adults with mild cognitive impairment (MCI) into nonpharmacological intervention trials are lacking.

Methods

Recruitment for EXERT, a multisite randomized controlled 18-month trial examining the effects of aerobic exercise on cognitive trajectory in adults with amnestic MCI, involved a diverse portfolio of strategies to enroll 296 participants.

Results

Recruitment occurred September 2016 through March 2020 and was initially slow. After mass mailings of 490,323 age- and geo-targeted infographic postcards and brochures, recruitment rates increased substantially, peaking at 16 randomizations/month in early 2020. Mass mailings accounted for 52% of randomized participants, whereas 25% were recruited from memory clinic rosters, electronic health records, and national and local registries. Other sources included news broadcasts, public service announcements (PSA), local advertising, and community presentations.

Discussion

Age- and geo-targeted mass mailing of infographic materials was the most effective approach in recruiting older adults with amnestic MCI into an 18-month exercise trial.

SUBMITTER: Shadyab AH

PROVIDER: S-EPMC9292825 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Publications

Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial.

Shadyab Aladdin H AH LaCroix Andrea Z AZ Feldman Howard H HH van Dyck Christopher H CH Okonkwo Ozioma C OC Tam Steven P SP Fairchild J Kaci JK Welsh-Bohmer Kathleen A KA Matthews Genevieve G Bennett Daniel D Shadyab Alexandre A AA Schafer Kimberly A KA Morrison Rosemary H RH Kipperman Sean A SA Mason Jennifer J Tan Donna D Thomas Ronald G RG Cotman Carl W CW Baker Laura D LD

Alzheimer's & dementia : the journal of the Alzheimer's Association 20210723 11

<h4>Introduction</h4>Effective strategies to recruit older adults with mild cognitive impairment (MCI) into nonpharmacological intervention trials are lacking.<h4>Methods</h4>Recruitment for EXERT, a multisite randomized controlled 18-month trial examining the effects of aerobic exercise on cognitive trajectory in adults with amnestic MCI, involved a diverse portfolio of strategies to enroll 296 participants.<h4>Results</h4>Recruitment occurred September 2016 through March 2020 and was initially ...[more]

PMID: 34297895

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Project description:BackgroundTo examine the effect of multicomponent exercise program on memory function in older adults with mild cognitive impairment (MCI), and identify biomarkers associated with improvement of cognitive functions.Methodology/principal findingsSubjects were 100 older adults (mean age, 75 years) with MCI. The subjects were classified to an amnestic MCI group (n = 50) with neuroimaging measures, and other MCI group (n = 50) before the randomization. Subjects in each group were randomized to either a multicomponent exercise or an education control group using a ratio of 1∶1. The exercise group exercised for 90 min/d, 2 d/wk, 40 times for 6 months. The exercise program was conducted under multitask conditions to stimulate attention and memory. The control group attended two education classes. A repeated-measures ANOVA revealed that no group × time interactions on the cognitive tests and brain atrophy in MCI patients. A sub-analysis of amnestic MCI patients for group × time interactions revealed that the exercise group exhibited significantly better Mini-Mental State Examination (p = .04) and logical memory scores (p = .04), and reducing whole brain cortical atrophy (p<.05) compared to the control group. Low total cholesterol levels before the intervention were associated with an improvement of logical memory scores (p<.05), and a higher level of brain-derived neurotrophic factor was significantly related to improved ADAS-cog scores (p<.05).Conclusions/significanceThe results suggested that an exercise intervention is beneficial for improving logical memory and maintaining general cognitive function and reducing whole brain cortical atrophy in older adults with amnestic MCI. Low total cholesterol and higher brain-derived neurotrophic factor may predict improvement of cognitive functions in older adults with MCI. Further studies are required to determine the positive effects of exercise on cognitive function in older adults with MCI.Trial registrationUMIN-CTR UMIN000003662 ctr.cgi&quest;function&hairsp;=&hairsp;brows&action&hairsp;=&hairsp;brows&type&hairsp;=&hairsp;summary&recptno&hairsp;=&hairsp;R000004436&language&hairsp;=&hairsp;J.

Project description:BACKGROUND:Alzheimer's disease (AD) is an epidemic with tremendous public health impacts because there are currently no disease-modifying therapeutics. Randomized controlled trials (RCTs) for prevention of AD dementia often use clinical endpoints that take years to manifest (e.g., cognition) or surrogate endpoints that are costly or invasive (e.g., magnetic resonance imaging [MRI]). Blood biomarkers represent a clinically applicable alternative surrogate endpoint for RCTs that would be both cost-effective and minimally invasive, but little is known about their value as surrogate endpoints for treatment responses in the prevention of AD dementia. METHODS:The objective of this study is to investigate blood neuropathological, neurodegenerative, and neurotrophic biomarkers as surrogate endpoints for treatment responses to three interventions in older adults with amnestic mild cognitive impairment (aMCI, a prodromal stage of AD): aerobic exercise, cognitive training, and combined aerobic exercise and cognitive training (ACT). We chose these three sets of biomarkers for their unique mechanistic associations with AD pathology, neurodegeneration and neurogenesis. This study is built on the ACT Trial (1R01AG055469), a single-blinded, multi-site, 2 × 2 factorial phase II RCT that examines the synergistic effects of a 6-month ACT intervention on cognition and MRI biomarkers (AD-signature cortical thickness and hippocampal volume) (n = 128). In this ACT Trial blood biomarkers study, we will enroll 120 ACT Trial participants with aMCI and measure blood biomarkers at baseline and at 3, 6, 12, and 18 months. The goals are to (1) determine the effect of interventions on blood biomarkers over 6 months, (2) evaluate blood biomarkers as surrogate endpoints for predicting cognitive responses to interventions over 18 months, and (3, exploratory) examine blood biomarkers as surrogate endpoints for predicting brain MRI biomarker responses to interventions over 18 months. DISCUSSION:This study aims to identify new blood biomarkers that can track cognitive decline or AD-related brain atrophy among patients with aMCI subjected to a regimen of aerobic exercise and cognitive training. Findings from this study will drive the further use of blood biomarkers in developing effective prevention and treatment strategies for AD dementia. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03313895. Registered on 18 October 2017.

Project description:The purpose of this study was to test the hypothesis that changes in cerebral vasomotor reactivity (CVMR) after 1-yr aerobic exercise training (AET) are associated with cognitive performances in individuals with amnestic mild cognitive impairment (MCI). Seventy sedentary patients with amnestic MCI were randomized to 1-yr moderate-to-vigorous intensity AET or stretching and toning (SAT) interventions. Cerebral blood flow velocity (CBFV) with transcranial Doppler, mean arterial pressure (MAP) with finapres plethysmograph, and EtCO2 with capnography were measured during hyperventilation (hypocapnia) and a modified rebreathing protocol (hypercapnia) to assess CVMR. Cerebrovascular conductance index (CVCi) was calculated by CBFV/MAP, and CVMR by ΔCBFV/ΔEtCO2 and ΔCVCi/ΔEtCO2. Episodic memory and executive function were assessed using standard neuropsychological tests (CVLT-II and D-KEFS). Cardiorespiratory fitness was assessed by peak oxygen uptake (V̇o2peak). A total of 37 patients (19 in SAT and 18 in AET) completed 1-yr interventions and CVMR assessments. AET improved V̇o2peak, increased hypocapnic CVMR, but decreased hypercapnic CVMR. The effects of AET on cognitive performance were minimal when compared with SAT. Across both groups, there was a negative correlation between changes in hypocapnic and hypercapnic CVMRs in CBFV% and CVCi% (r = -0.741, r = -0.725, P < 0.001). Attenuated hypercapnic CVMR, but not increased hypocapnic CVMR, was associated with improved cognitive test scores in the AET group. In conclusion, 1-yr AET increased hypocapnic CVMR and attenuated hypercapnic CVMR which is associated cognitive performance in patients with amnestic MCI.NEW & NOTEWORTHY One-year moderate-to-vigorous intensity aerobic exercise training (AET) improved cardiorespiratory fitness (V̇o2peak), increased hypocapnic cerebral vasomotor reactivity (CVMR), whereas it decreased hypercapnic CVMR when compared with stretching and toning in patients with amnestic mild cognitive impairment (MCI). Furthermore, changes in hypercapnic CVMR with AET were correlated with improved memory and executive function. These findings indicate that AET has an impact on cerebrovascular function which may benefit cognitive performance in older adults who have high risk of Alzheimer's disease.

Project description:BackgroundIntervention adherence is crucial to ensure cognitive benefits in trials designed to prevent cognitive decline. During the coronavirus disease 2019 (COVID-19) pandemic, the Japan-Multimodal Intervention Trial for the Prevention of Dementia offered live online exercise sessions to older adults with mild cognitive impairment (MCI).ObjectivesTo assess adherence and aerobic exercise intensity through live online exercise sessions in older adults with MCI.DesignPosthoc analysis of the 18-month, multi-center, randomized controlled trial.SettingThe study was conducted across five institutions in Japan.ParticipantsOlder adults aged 65-85 years who were assigned to the intervention group and completed the intervention. Participants were stratified by region (Aichi and Tokyo), where the state of emergency duration due to COVID-19 varied.InterventionsThe intervention group participated in multidomain interventions, including 90-minute group-based physical exercise sessions held weekly for 78 sessions. During the state of emergency, live online sessions were conducted via video conferencing.MeasurementsAttendance rates and aerobic exercise intensity (based on heart rates) during online and onsite sessions were compared using the Wilcoxon signed-rank test.ResultsA total of 207 participants were analyzed. Over 18 months, 78 exercise sessions were conducted, including live online sessions. In the Aichi region, 2 online sessions were held, while in the Tokyo region, 24 online sessions were conducted. In the Tokyo region, adherence was higher in online sessions compared to onsite sessions (92 % vs. 86 %, p = 0.046), while exercise intensity showed no significant difference (49 % vs. 52 %, p = 0.279). No adverse events were reported.ConclusionsLive online exercise sessions were safe, feasible, and demonstrated adherence and intensity comparable to onsite sessions.Trial registrationThe trial was registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) on November 24, 2019 (UMIN000038671) (https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044075).

Dataset Information

Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial.

Introduction

Methods

Results

Discussion

Publications

Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial.

Similar Datasets

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