Lifestyle Interventions for Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Waterloo
Disqualifiers: Dementia, Stroke, Major psychiatric disorder, others
Trial Summary
What is the purpose of this trial?
The objective of this study is to investigate the feasibility of a virtually-delivered 6-month exercise and nutrition intervention in older adults with executive subjective cognitive decline (SCD). Feasibility will be determined by recruitment, retention, and adherence rates. Preliminary changes in cognition, physical function, and quality of life will be assessed as secondary outcomes. The study will recruit 140 participants aged 65 to 80 who report they feel that their memory or other thinking abilities are declining. Participants will be randomized into one of four study arms receiving different combinations of healthy lifestyle interventions. Assessments will be conducted virtually at baseline, post-intervention (6 months), and follow-up (12 months). All intervention sessions and assessment visits will be conducted online using the Zoom Healthcare platform and participants will log on using their own devices from home.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment LEAD 2.0 for mild cognitive impairment?
Research shows that combining physical exercise and diet can help improve cognitive function in people with mild cognitive impairment, potentially slowing the progression to dementia. Additionally, mind-body exercises and lifestyle changes have been found to enhance cognitive performance in middle-aged and older adults with mild cognitive impairment.12345
Is the LEAD 2.0 intervention generally safe for humans?
Lifestyle clinical trials, including those involving exercise and diet, are generally safe with no significant increase in serious adverse events compared to control groups. However, some trials involving diet/supplement and multi-modal interventions showed an increased risk of adverse events, so these results should be considered carefully.16789
How is the LEAD 2.0 treatment different from other treatments for mild cognitive impairment?
The LEAD 2.0 treatment is unique because it focuses on lifestyle changes, combining exercise and diet, rather than relying on medication. This approach is designed to improve cognitive function and brain health through non-pharmacological means, which may be more accessible and sustainable for some patients.17101112
Eligibility Criteria
The LEAD 2.0 trial is for adults aged 65-80 in Quebec, Ontario, Manitoba, and Saskatchewan who feel their cognitive abilities are declining but do not have dementia or other severe brain conditions. They should be physically inactive (<75min/week of exercise), have a poor diet, and be able to use a computer with internet for remote participation.Inclusion Criteria
I am between 65 and 80 years old.
Reside in Quebec, Ontario, Manitoba, or Saskatchewan
Low physical activity levels (<75 minutes/week of moderate/vigorous physical activity)
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Exclusion Criteria
I have been diagnosed with a chronic brain condition.
Sensory impairments that hinder participation in the intervention or assessments
Major psychiatric disorder
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
2 visits (virtual)
Treatment
Participants engage in a 6-month virtual exercise and nutrition intervention
6 months
Weekly virtual sessions
Follow-up
Participants are monitored for changes in cognition, physical function, and quality of life
6 months
2 visits (virtual)
Treatment Details
Interventions
- LEAD 2.0 (Behavioural Intervention)
Trial OverviewThis study tests if older adults can stick to a 6-month virtual program focused on exercise and nutrition to improve cognition, physical function, and quality of life. Participants will join one of four groups receiving different combinations of exercises (EX), stretching (STRETCH), dietary changes (DIET), or educational sessions (ED).
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: EX + DIETExperimental Treatment2 Interventions
Participants will engage in 3 sessions per week (2 EX, 1 DIET, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).
Group II: EX + EDActive Control2 Interventions
Participants will engage in 3 sessions per week (2 EX, 1 ED, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).
Group III: STRETCH + DIETActive Control2 Interventions
Participants will engage in 3 sessions per week (2 STRETCH, 1 DIET, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).
Group IV: STRETCH + EDPlacebo Group2 Interventions
Participants will engage in 3 sessions per week (2 STRETCH, 1 ED) totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WaterlooWaterloo, Canada
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Who Is Running the Clinical Trial?
University of WaterlooLead Sponsor
BaycrestCollaborator
University of OttawaCollaborator
Université de MontréalCollaborator
References
Real World Recruiting of Older Subjects with Mild Cognitive Impairment for Exercise Trials: Community Readiness is Pivotal. [2022]Prevention trials in subjects with mild cognitive impairment (MCI), especially lifestyle interventions, can be difficult to carry out, particularly the recruitment and retention of subjects. We experienced these challenges in our multi-site one-year exercise trial in MCI, NeuroExercise. Trial recruitment rates differed significantly across sites; the non-medical sport university site, providing free access to a range of group exercise in a sports environment, proved far more successful than memory clinics linked to hospitals. This suggests that non-medical settings and a non-medical research community facilitating physical activities may be important factors in recruitment of subjects with MCI for large prevention trials.
[Effect of physical exercise and diet based interventions on the evolution of cognitive impairment to dementia in subjects older than 45 years. A systematic review.] [2023]Dementia is a global public health problem. Drugs for this indication have shown limited benefit. The aim of the present study is to synthesize and analyze the available scientific evidence about effectiveness of interventions on diet and / or physical exercise by considering cognitive function as an outcome measure, in people over 45 years of age with mild cognitive impairment (MCI) in their evolution to Alzheimer's disease.
Effects of mind-body exercise on cognitive performance in middle-aged and older adults with mild cognitive impairment: A meta-analysis study. [2023]To systematically evaluate the clinical efficacy of physical and mental exercise on cognitive performance in middle-aged people with mild cognitive impairment (MCI).
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. [2022]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).
Lifestyle Risk Factors and Cognitive Outcomes from the Multidomain Dementia Risk Reduction Randomized Controlled Trial, Body Brain Life for Cognitive Decline (BBL-CD). [2021]To evaluate the efficacy of a multidomain intervention to reduce lifestyle risk factors for Alzheimer's disease (AD) and improve cognition in individuals with subjective cognitive decline (SCD) or mild cognitive impairment (MCI).
A Retrospective Analysis of Serious Adverse Events and Deaths in US-Based Lifestyle Clinical Trials for Cognitive Health. [2023]This retrospective analysis assessed the serious adverse events and deaths reported in lifestyle clinical trials designed to enhance cognitive health in older adults living in the United States. Data was collected from studies conducted between January 1, 2000, and July 19, 2023, using the ClinicalTrials.gov application programming interface. Our query revealed that 76% of these studies did not report trial results. The remaining studies with reported results were categorized under one of four intervention types: Cognitive/Behavioral, Exercise/Movement, Diet/Supplement, and Multi-modal. When all trial types are considered together, the results indicate that lifestyle clinical trials are safe, with no significant increase in relative risk of experiencing an SAE in an intervention group over a control group. And although the increase in relative risk of death in an intervention group over a control group was significant at 28% (X2 (1, N = 36), p < 0.00688), the probability of death was not higher than the U.S. mortality rates by age. When assessing the data using intervention type, Diet/Supplement trials and Multi-modal trials both had an increase in relative risk of experiencing an SAE in the intervention over the control group, with Diet/Supplement trials at 16% (X2 (1, N = 2), p < 0.0263) and Multi-modal trials at 365% (X2 (1, N = 5), p < 0.000213). The Diet/Supplement trials also had an increased risk of death at 67% (X2 (1, N = 2), p < 0.000197). These results should be taken with careful consideration. Due to such a low reporting rate, the 36 studies included in this analysis do not accurately represent the majority of lifestyle clinical trials conducted in the U.S. This study is valuable in that it highlights the importance of reporting clinical trial results, which will improve transparency in trial results and allow for more accurate assessments of safety in the growing field of cognitive aging and lifestyle interventions for older adults.
Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study. [2018]Age-related cognitive impairment and dementia are an increasing societal burden. Epidemiological studies indicate that lifestyle factors, e.g. physical, cognitive and social activities, correlate with reduced dementia risk; moreover, positive effects on cognition of physical/cognitive training have been found in cognitively unimpaired elders. Less is known about effectiveness and action mechanisms of physical/cognitive training in elders already suffering from Mild Cognitive Impairment (MCI), a population at high risk for dementia. We assessed in 113 MCI subjects aged 65-89 years, the efficacy of combined physical-cognitive training on cognitive decline, Gray Matter (GM) volume loss and Cerebral Blood Flow (CBF) in hippocampus and parahippocampal areas, and on brain-blood-oxygenation-level-dependent (BOLD) activity elicited by a cognitive task, measured by ADAS-Cog scale, Magnetic Resonance Imaging (MRI), Arterial Spin Labeling (ASL) and fMRI, respectively, before and after 7 months of training vs. usual life. Cognitive status significantly decreased in MCI-no training and significantly increased in MCI-training subjects; training increased parahippocampal CBF, but no effect on GM volume loss was evident; BOLD activity increase, indicative of neural efficiency decline, was found only in MCI-no training subjects. These results show that a non pharmacological, multicomponent intervention improves cognitive status and indicators of brain health in MCI subjects.
Feasibility and acceptability of a multi-domain intervention to increase Mediterranean diet adherence and physical activity in older UK adults at risk of dementia: protocol for the MedEx-UK randomised controlled trial. [2022]Dementia prevalence continues to increase, and effective interventions are needed to prevent, delay or slow its progression. Higher adherence to the Mediterranean diet (MedDiet) and increased physical activity (PA) have been proposed as strategies to facilitate healthy brain ageing and reduce dementia risk. However, to date, there have been no dementia prevention trials in the UK focussed on combined dietary and PA interventions. This study aims to: (1) assess feasibility and acceptability of a theory-underpinned digital and group-based intervention for dementia risk reduction in an 'at risk' UK cohort; (2) evaluate behaviour change responses to the intervention; and, (3) provide information on cognitive, neurological, vascular and physiological outcomes to inform the design of a follow-on, full-scale efficacy trial.
Adherence to exercise interventions in older people with mild cognitive impairment and dementia: A systematic review and meta-analysis. [2021]Adherence to physical exercise is associated with multiple benefits in people with mild cognitive impairment (MCI) and dementia. Given the gap in research, this systematic literature review aimed to determine in the context of exercise intervention studies for people with MCI and dementia: 1. How adherence is defined, monitored and recorded; 2. Adherence rates; 3. Attrition, compliance and adverse events and 4. Intervention characteristics associated with adherence. Embase, Medline, PsychInfo, SPORTDiscus, AMED, CINAHL and the International Bibliography of Social Sciences were searched in November 2018. The data were analyzed through descriptive and correlation/inferential statistics. Forty-one studies were included, 34 involving participants with dementia (n = 2149) and seven participants with MCI (n = 970). Half of the studies operationally defined adherence. Mean adherence rate was 70% [CI, 69-73%]. Adherence was significantly associated with endurance/resistance training, and interventions not including walking. The review found a lack of consistency around reporting of adherence and of key variables mediating adherence, including compliance, attrition and adverse events. Further research using more reliable measures is needed to confirm whether a correlation exists between length of interventions and adherence in participants with MCI and dementia and to identify the factors or strategies that mediate adherence in this population. Relevant implications for practice include a consideration in the development of new interventions of elements associated with higher adherence in this review, such as endurance/resistance training, and the provision of exercise in group formats.
Association of Modifiable Lifestyle Factors With Cortical Amyloid Burden and Cerebral Glucose Metabolism in Older Adults With Mild Cognitive Impairment. [2020]Understanding the association of lifestyle factors with mild cognitive impairment enables the development of evidence-based interventions for delaying cognitive impairment.
Exercise training for cognitive and physical function in patients with mild cognitive impairment: A PRISMA-compliant systematic review and meta-analysis. [2022]This systematic review evaluates the effect of exercise training in the treatment of patients with mild cognitive impairment (MCI).
NeuroExercise: The Effect of a 12-Month Exercise Intervention on Cognition in Mild Cognitive Impairment-A Multicenter Randomized Controlled Trial. [2021]Exercise intervention studies in mild cognitive impairment (MCI), a prodromal stage of Alzheimer's disease (AD), have demonstrated inconsistent yet promising results. Addressing the limitations of previous studies, this trial investigated the effects of a 12-month structured exercise program on the progression of MCI. The NeuroExercise study is a multicenter randomized controlled trial across three European countries (Ireland, Netherlands, Germany). Hundred and eighty-three individuals with amnestic MCI were included and were randomized to a 12-month exercise intervention (3 units of 45 min) of either aerobic exercise (AE; n = 60), stretching and toning exercise (ST; n = 65) or to a non-exercise control group (CG; n = 58). The primary outcome, cognitive performance, was determined by an extensive neuropsychological test battery. For the primary complete case (CC) analyses, between-group differences were analyzed with analysis of covariance under two conditions: (1) the exercise group (EG = combined AE and ST groups) compared to the CG and (2) AE compared to ST. Primary analysis of the full cohort (n = 166, 71.5 years; 51.8% females) revealed no between-group differences in composite cognitive score [mean difference (95% CI)], 0.12 [(-0.03, 0.27), p = 0.13] or in any cognitive domain or quality of life. VO2 peak was significantly higher in the EG compared to the CG after 12 months [-1.76 (-3.39, -0.10), p = 0.04]. Comparing the two intervention groups revealed a higher VO2peak level in the aerobic exercise compared to the stretching and toning group, but no differences for the other outcomes. A 12-month exercise intervention did not change cognitive performance in individuals with amnestic MCI in comparison to a non-exercise CG. An intervention effect on physical fitness was found, which may be an important moderator for long term disease progression and warrants long-term follow-up investigations. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02913053, identifier: NCT02913053.