Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, memory impairment, Physical Activity, Exercise, Cognitive Training, Veterans, Older Adults
Brief summary
This two-year study will evaluate the feasibility of an exercise training augmentation for cognitive training intervention to improve memory performance in Veterans with a diagnosis of amnestic Mild Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise phase and 2) a cognitive training program. The exercise phase will be an aquatic based exercise program. A combination of exercise and cognitive training programs designed for persons without cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy older adults, it is important to adapt these programs for persons beginning to exhibit clinically significant memory problems, such as those with aMCI.
Detailed description
The primary research question of the proposed study is this: Is a combination water-based physical exercise + cognitive training program for older Veterans with amnestic Mild Cognitive Impairment (MCI) feasible? The primary aims of the proposed research are: 1) demonstrate adequate recruitment and retention rates; 2) refinement of inclusion/exclusion criteria; and 3) further refine the combination waterbased physical exercise + cognitive training (WATER+CT) intervention. These aims will be tested in a two-phase clinical trial with a single group design: 1) exercise training phase and 2) a cognitive training phase. The exercise training phase consists of a water-based physical exercise program that emphasizes cardiovascular fitness and strength training through a combination of non-weight bearing exercises that include land-based stretching and water-based activities. This 2-year pilot project will include 50 Veterans diagnosed with amnestic MCI age 50-90. The exercise component consists of a six-month water-based exercise program followed by a four-week cognitive training program. For the first two months of the water-based exercise program, Veterans will come to thrice-weekly group sessions at Aquatic Therapy Center at the VA Palo Alto Health Care System. This will transition to a self-paced exercise program for the remaining four months. After completion of the exercise program, Veterans will begin classroom-based cognitive training at the VA Palo Alto Health Care System (VAPAHCS). The cognitive training is based on an efficacious cognitive program that is structured around two components, pre-training and mnemonic training, both of which have been used successfully in persons with aMCI. Assessments of adherence will be administered throughout treatment and measures of feasibility will be completed post-treatment. Participants will complete a variety of neuropsychological measures taping into areas of cognition such as attention, executive functioning, and memory. To study possible predictors of treatment response, the investigators will also collect biological (cardiovascular functioning and brain derived neurotrophic factor \[BDNF\] plasma levels) and genetic data (APOE and BDNF genotypes) from these participants. The investigators hope to provide initial evidence of the feasibility of a waterbased exercise training augmentation for cognitive training thus laying the groundwork for full-scale clinical trials targeting the lessening of cognitive impairment in persons with amnestic MCI by non-pharmacological means.
Interventions
BEHAVIORALWater-based Activity + Cognitive Training
This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Veterans aged 50 - 90 * diagnosis of aMCI * available informant * at least one musculoskeletal problem * sufficient visual and auditory acuity to allow neuropsychological testing * willingness to participate in exercise training +cognitive training program for eight months * approval of primary provider to participate in an exercise trial
Exclusion criteria
* current untreated severe psychiatric disorder, such as: * Bipolar I * Schizophrenia * or Major Depressive Disorder, determined by the Mini International Neuropsychiatric Interview (MINI) * diagnosis of dementia, Clinical Dementia Rating (CDR) \> 0.5; modified Hachinski score 4; or delirium * history of neurological disorder, e.g.: * multiple sclerosis * seizure disorder * stroke * history of transient ischemic attacks, or systemic illness affecting central nervous system (CNS) function, e.g.: * liver failure * kidney failure * congestive heart failure * systemic cancer * acute illness or unstable chronic illness e.g., history of severe liver disease * cirrhosis * esophageal * varices * ascites * portal hypertension * hepatic encephalopathy * current severe cardiac disease, e.g.: * uncontrolled atrial fibrillation, defined as mean 24 hour heart rate \>85 beats/min, or 24 hour maximal ventricular rate \>150 beats/min * uncontrolled ventricular arrhythmias, defined as recurrent ventricular tachycardia \> 3 beats in succession, or 24 hour packed cell volume (PVC) count \> 20%; active * pericarditis or myocarditis * Class III/IV heart failure and / or ejection fraction \< 20% * thrombophlebitis * pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen * embolism within past six months * inability to participate in an exercise stress test or inability to exercise consistently because of orthopedic or musculoskeletal problems * morbid obesity (BMI \> 39) * inability to read, verbalize understanding and voluntarily sign the Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention and Recruitment Rates | Through Study Completion, an average of 8 months | Feasibility will be demonstrated through ratio of enrolled to completed participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Delayed Recall of a Word List | Through Study Completion, an average of 8 months | Change From Baseline on the Delayed Recall of a Word List at 8 months |
| Participant Adherence to Protocol | Through Study Completion, an average of 8 months | Participant completion of study related measurements including pedometers, activity logs, cognitive training homework |
| Appropriateness of Inclusion and Exclusion Criteria | From time of consent until completion of Time 3 assessments, an average of 8 months | Number of reported serious and non-serious adverse events reported by participants who were eligible for study participation. |
Countries
United States
Participant flow
Pre-assignment details
After providing informed consent, enrolled participants were screened for eligibility. Only those enrolled participants who met all eligibility criteria were allowed to participate in the water-based activity + cognitive training intervention.
Participants by arm
| Arm | Count |
|---|---|
| Water Based Activity+ Cognitive Training This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Water Based Activity+ Cognitive Training |
|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 7 / 31 |
| serious Total, serious adverse events | 3 / 31 |
Outcome results
Primary
Retention and Recruitment Rates
Feasibility will be demonstrated through ratio of enrolled to completed participants
Time frame: Through Study Completion, an average of 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Water Based Activity+ Cognitive Training | Retention and Recruitment Rates | 21 Participants |
Secondary
Appropriateness of Inclusion and Exclusion Criteria
Number of reported serious and non-serious adverse events reported by participants who were eligible for study participation.
Time frame: From time of consent until completion of Time 3 assessments, an average of 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Water Based Activity+ Cognitive Training | Appropriateness of Inclusion and Exclusion Criteria | 10 # of events |
Secondary
Change in Delayed Recall of a Word List
Change From Baseline on the Delayed Recall of a Word List at 8 months
Time frame: Through Study Completion, an average of 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Water Based Activity+ Cognitive Training | Change in Delayed Recall of a Word List | 3.94 Words Recalled | Standard Deviation 3.94 |
Secondary
Participant Adherence to Protocol
Participant completion of study related measurements including pedometers, activity logs, cognitive training homework
Time frame: Through Study Completion, an average of 8 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Water Based Activity+ Cognitive Training | Participant Adherence to Protocol | 63.5 percentage of weeks completed homework |