Mild Cognitive Impairment
Conditions
Keywords
Mild cognitive impairment, exercise therapy, patient adherence
Brief summary
This project is assessing the feasibility of a novel home-based exercise intervention to improve episodic memory in individuals with mild cognitive impairment.
Detailed description
Background/Rationale: Alzheimer's disease (AD) afflicts nearly 6 million Americans, a number projected to grow in coming decades. AD is known to have a long preclinical phase in which pathophysiologic processes develop many years, even decades, before the onset of clinical symptoms. During this preclinical phase there is evidence of unremitting decline in cognitive function, particularly in episodic memory. Thus far, evidence of the efficacy of pharmacological interventions to slow this decline in cognitive function has been limited, leading to increasing interest in the utility of nonpharmacological interventions including exercise. Objective: The investigators propose to assess the feasibility of a novel home-based exercise intervention to improve episodic memory in Veterans with mild cognitive impairment (MCI). Methods: The investigators will estimate the difference between the intervention (n=30) and the control group (n=30) on 6-month change in episodic memory (Rey-Osterrieth Complex Figure Test, Wechsler Logical Memory Test) as well as the effect size, which will be used as a basis for sample size calculation for a proposed larger study. Participants will be male and female Veterans 50 years of age or older with amnestic MCI.
Interventions
BEHAVIORALStructured exercise
Exercise instruction and encouragement
BEHAVIORALHealth Education
Provision of general information about a variety of health topics
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Amnestic MCI * Ability to use a telephone without assistance
Exclusion criteria
* Angina Pectoris * History of myocardial infarction within 6 months * History of ventricular dysrhythmia requiring current therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months | baseline and 6 months | Wechsler Logical Memory Task is a recall test involving 2 short stories. Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories). Outcome is change in the delayed recall score from baseline to 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months | baseline and 6 months | Rey-Osterrieth Complex Figure Test is a recall test involving a complex figure. Possible scores on the delayed recall task range from 0 (no accurate details recalled for the figure) to 36 (all details accurately recalled for the figure). Outcome is change in the delayed recall score from baseline to 6 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Group Structured exercise
Structured exercise: Exercise instruction and encouragement | 29 |
| Control Group Health education
Health Education: Provision of general information about a variety of health topics | 31 |
| Total | 60 |
Baseline characteristics
| Characteristic | Exercise Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 27 Participants | 52 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 31 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 30 Participants | 56 Participants |
| Rey-Osterrieth Complex Figure Test | 9.0 units on a scale STANDARD_DEVIATION 4.6 | 7.6 units on a scale STANDARD_DEVIATION 5.2 | 8.3 units on a scale STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 27 Participants | 29 Participants | 56 Participants |
| Wechsler Logical Memory Task | 10.3 units on a scale STANDARD_DEVIATION 5.6 | 9.5 units on a scale STANDARD_DEVIATION 7.1 | 9.9 units on a scale STANDARD_DEVIATION 6.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 0 / 29 | 0 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
Primary
Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months
Wechsler Logical Memory Task is a recall test involving 2 short stories. Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories). Outcome is change in the delayed recall score from baseline to 6 months.
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Group | Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months | 0.74 units on a scale | Standard Deviation 4 |
| Control Group | Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months | -0.87 units on a scale | Standard Deviation 4.7 |
Secondary
Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months
Rey-Osterrieth Complex Figure Test is a recall test involving a complex figure. Possible scores on the delayed recall task range from 0 (no accurate details recalled for the figure) to 36 (all details accurately recalled for the figure). Outcome is change in the delayed recall score from baseline to 6 months.
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Group | Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months | 1.18 units on a scale | Standard Deviation 4.5 |
| Control Group | Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months | 0.46 units on a scale | Standard Deviation 3.3 |