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A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care.

ABSTRACT: Objectives:To examine the feasibility and preliminary effectiveness of (1) combining cognitive training, mind-body physical exercise, and nurse-led risk factor modification (CPR), (2) nurse-led risk factor modification (RFM), and (3) health advice (HA) on reducing cognitive decline among older adults with mild cognitive impairment (MCI). Methods:It was a 3-arm open-labeled pilot randomized controlled trial in the primary care setting in Hong Kong. Nineteen older adults with MCI were randomized to either CPR (n = 6), RFM (n = 7), or HA (n = 6) for 6 months. The primary outcome was the feasibility of the study. Secondary outcomes included the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), the Montreal Cognitive Assessment Hong Kong version (HK-MoCA), the Clinical Dementia Rating (CDR), the Disability Assessment for Dementia (DAD), quality of life, depression, anxiety, physical activity, health service utilization, and diet. Results:Nineteen out the 98 potential patients were recruited, with a recruitment rate of 19% (95% CI [12-29]%, P = 0.243). The adherence rate of risk factor modification was 89% (95% CI [65-98]%, P = 0.139) for CPR group and 86% (95% CI [63-96]%, P = 0.182) for RFM group. In the CPR group, 53% (95% CI [36-70]%, P = 0.038) of the Tai Chi exercise sessions and 54% (95% CI [37-71]%, P = 0.051) of cognitive sessions were completed. The overall dropout rate was 11% (95% CI [2-34]%, P = 0.456). Significant within group changes were observed in HK-MoCA in RFM (4.50 ± 2.59, P = 0.008), cost of health service utilization in CPR (-4000, quartiles: -6800 to -200, P = 0.043), fish and seafood in HA (-1.10 ± 1.02, P = 0.047), and sugar in HA (2.69 ± 1.80, P = 0.015). Group × time interactions were noted on HK-MoCA favoring the RFM group (P = 0.000), DAD score favoring CPR group (P = 0.027), GAS-20 favoring CPR group (P = 0.026), number of servings of fish and seafood (P = 0.004), and sugar (P < 0.001) ate per day. Conclusions:In this pilot study, RFM and the multi-domain approach CPR were feasible and had preliminary beneficial effects in older adults with MCI in primary care setting in Hong Kong. Trial registration:Chinese Clinical Trial Registry (ChiCTR1800015324).

SUBMITTER: Xu Z

PROVIDER: S-EPMC7482623 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care.

Xu Zijun Z Zhang Dexing D Lee Allen T C ATC Sit Regina W S RWS Wong Carmen C Lee Eric K P EKP Yip Benjamin H K BHK Tiu Jennifer Y S JYS Lam Linda C W LCW Wong Samuel Y S SYS

PeerJ 20200907

<h4>Objectives</h4>To examine the feasibility and preliminary effectiveness of (1) combining cognitive training, mind-body physical exercise, and nurse-led risk factor modification (CPR), (2) nurse-led risk factor modification (RFM), and (3) health advice (HA) on reducing cognitive decline among older adults with mild cognitive impairment (MCI).<h4>Methods</h4>It was a 3-arm open-labeled pilot randomized controlled trial in the primary care setting in Hong Kong. Nineteen older adults with MCI we ...[more]

PMID: 33194354

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Project description:IntroductionCommunity-dwelling older adults living with subjective cognitive decline or mild cognitive impairment may experience decreased efficiency in their overall functional performance. This decreased cognitive efficiency may result in anxiety, low mood, perceived stress and decreased emotional well-being and quality-of-life. These psychological symptoms may further exacerbate cognitive decline.Exploring non-pharmacological interventions such as mindfulness within primary care is vital in enabling individuals to develop strategies to manage cognitive impairment or psychological symptoms. Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated. The primary objective of this study is to explore the feasibility of conducting a randomised controlled trial of an occupational therapist-led MBSR programme within primary care.MethodsConvergent mixed-methods, randomised control feasibility trial with 40 participants from an interprofessional primary care team in Toronto, Ontario. Participants are randomised into the 8-week MBSR group or wait-list control will be compared at baseline, postintervention and 4weeks follow-up. The primary aim is to determine the feasibility of the intervention with this population and setting. The secondary aim is to examine perceived satisfaction with functional performance as measured by the Canadian Occupational Performance Measure. Secondary clinical outcomes include psychological symptoms.AnalysisInvestigators will analyse the quantitative and qualitative data strands separately. Descriptive statistics, focus group and interviews will then be merged and further analysed to best understand the feasibility and preliminary clinical outcomes from the study.Ethics and disseminationThe study is approved by Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418). The study will follow Standard Protocol Items: Recommendations for Interventional Trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.Trial registration numberNCT03867474; Pre-results.

Project description:BackgroundIncreasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults.ObjectiveIn this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial.MethodsIn the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463).ResultsResults will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021.ConclusionsThe findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial.Trial registrationInternational Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980.International registered report identifier (irrid)DERR1-10.2196/18929.

Project description:BackgroundTelemonitoring (TM) interventions have been designed to support care delivery and engage patients in their care at home, but little research exists on TM of complex chronic conditions (CCCs). Given the growing prevalence of complex patients, an evaluation of multi-condition TM is needed to expand TM interventions and tailor opportunities to manage complex chronic care needs.ObjectiveThis study aims to evaluate the feasibility and patients' perceived usefulness of a multi-condition TM platform in a nurse-led model of care.MethodsA pragmatic, multimethod feasibility study was conducted with patients with heart failure (HF), hypertension (HTN), and/or diabetes. Patients were asked to take physiological readings at home via a smartphone-based TM app for 6 months. The recommended frequency of taking readings was dependent on the condition, and adherence data were obtained through the TM system database. Patient questionnaires were administered, and patient interviews were conducted at the end of the study. An inductive analysis was performed, and codes were then mapped to the normalization process theory and Implementation Outcomes constructs by Proctor.ResultsIn total, 26 participants were recruited, 17 of whom used the TM app for 6 months. Qualitative interviews were conducted with 14 patients, and 8 patients were interviewed with their informal caregiver present. Patient adherence was high, with patients with HF taking readings on average 76.6% (141/184) of the days they were asked to use the system and patients with diabetes taking readings on average 72% (19/26) of the days. The HTN adherence rate was 55% (29/52) of the days they were asked to use the system. The qualitative findings of the patient experience can be grouped into 4 main themes and 13 subthemes. The main themes were (1) making sense of the purpose of TM, (2) engaging and investing in TM, (3) implementing and adopting TM, and (4) perceived usefulness and the perceived benefits of TM in CCCs.ConclusionsMulti-condition TM in nurse-led care was found to be feasible and was perceived as useful. Patients accepted and adopted the technology by demonstrating a moderate to high level of adherence across conditions. These results demonstrate how TM can address the needs of patients with CCCs through virtual TM assessments in a nurse-led care model by supporting patient self-care and keeping patients connected to their clinical team.

Dataset Information

A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care.

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A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care.

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