An interventional study of Mindfulness training and Aerobic training in Cognitive Impairment and Cardiovascular Risk Factor, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Prevention
Among 1,418 studies in Cognitive Dysfunction with a site in United States — 328 open to participants now, 432 under way, 13 of them phase 3. Cognitive Dysfunction · United States.
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, this one is the 723rd largest by enrollment of the 1,143 interventional ones that give a count, is one of 59 that started in 2016, is one of 713 with no phase, and was the 469th registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
Browse Cognitive Dysfunction studies →328 of the 1,418 studies in Cognitive Dysfunction with a site in United States are open now. Recruiting first, the newest first:
National Institute of Mental Health (NIMH) · Sites in United States
Prevention Research Consortium Corp. · Sites in United States
University of California, San Francisco · Sites in United States
The University of Texas Medical Branch, Galveston · Sites in United States
Medical University of South Carolina · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,418 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 125 · Phase 2 233 · Phase 3 54 · Phase 4 58
First in 1993; this study’s year is marked. 59 started in 2016.
This study's enrollment of 38 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 58 across the 1,143 interventional studies, 150 across the 270 observational. Of the 885 that completed or were terminated, 377 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
209 of 1,418 have an industry lead sponsor. The 10 most frequent:
The Miriam Hospital is the lead sponsor of 182 studies on the registry; 15 are open to participants now.
The Miriam Hospital has 2 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
176 of the studies in Cognitive Dysfunction with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT06191965Phase 3Mclean HospitalMitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction | 2027-01-31 |
| NCT06950190Phase 3Ellis MedicineEvaluating Cognitive Changes on Patients in Chemotherapy (ECCPC) | 2027-02-20 |
| NCT03560960Boston UniversityMulti-Center Development of a Novel Diagnostic Test for Alzheimer's Disease | 2026-11 |
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to explore whether physical exercise, mindfulness training, or both interventions together can improve cognitive function in individuals with multiple risk factors for the development of dementia in the future.
The investigators will test the feasibility and acceptability of a combined mindfulness training + aerobic training intervention, vs. either alone or none to improve cognitive function in older adults with cognitive impairment. The investigators will also obtain estimates of effect sizes (and confidence intervals) on cognitive function. Preliminary analyses will be conducted to explore the mediating role of changes in aerobic capacity, physical activity, vascular risk factors, and mindfulness skills. Assessments will be conducted at baseline, 3-, and 6- months since baseline.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 mindfulness training class (1 hour) every week for 8 weeks.
Behavioral: Mindfulness training
3 aerobic training sessions (1 hour) per week for 12 weeks.
Behavioral: Aerobic training
2 aerobic training sessions + 1 mindfulness training class every week for 8 weeks, then continue with 3 aerobic training sessions/ week for 4 additional weeks.
Behavioral: Mindfulness training · Behavioral: Aerobic training
The mindfulness training protocol will include the following basic components of traditional mindfulness-based stress reduction training: 1) training in awareness of sensations ("body scan"); 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life, and in recognizing when the attention is no longer focused on a specific object of attention; and 4) training in 'open awareness'.
Exercise sessions will be led by CPR- and exercise-certified YMCA instructors and supervised by the senior research assistant. Sessions will consist of 10 minutes of warm-up, 40 minutes of aerobic exercise (walking on a treadmill), 10 minutes of cool down and stretching. Participants will receive heart monitors at the beginning of the study and will be trained by the senior research assistant to exercise targeting heart rates at 65-75% of the age predicted max heart rate or at an intensity of 12-13 in the Borg scale of the rate of perceived exertion.
Retention rates of 80% at the final follow-up visit
The investigators will consider the study feasible under this condition
Time frame: 3 months from baseline
Number of participants who attended at least 70% of the planned sessions
The investigators will consider the study feasible under this condition
Time frame: 3 months from baseline
Number of participants who completed 70% of the assigned individual home practice exercises
The investigators will consider the study feasible under this condition
Time frame: 3 months from baseline
Acceptability will be assessed using a satisfaction survey
Acceptability will be assessed using a satisfaction survey. The intervention will be considered acceptable if ≥80% of participants responds that they are at least somewhat satisfied with the intervention.
Time frame: 3 months from baseline
Effect size on cognitive function
Preliminary estimates of effect size of mindfulness training alone vs. aerobic training alone, both, or neither on changes from baseline cognitive function.
Time frame: baseline, 3, 6 months
An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)
Five Facets of Mindfulness questionnaire (short form) is a 12-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Time frame: baseline, 3, 6 months
An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
The HADS is a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity
Time frame: baseline, 3, 6 months
Exploratory outcome: waist-to-hip ratio
waist-to-hip ratio
Time frame: baseline, 3, 6 months
An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test
The 6 minute walking test
Time frame: baseline, 3, 6 months
Exploratory outcome: blood pressure
blood pressure
Time frame: baseline, 3, 6 months
An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support
A 12-item, uni-dimensional tool to measure how one perceives their social support system, including individuals sources of social support (i.e., family, friends, and significant other).
Time frame: baseline, 3, 6 months
Plan to share: No
Ran from Apr 2016 to primary completion in Nov 2018, 31 months.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 31 months is above that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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