Amnestic Mild Cognitive ImpairmentNCT01962038
A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
A study testing Combined Aerobic and Resistance Exercise, Stretching Exercises and Cognitive Training in people with Amnestic Mild Cognitive Impairment, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The purpose of this study is examine the efficacy of a combination physical exercise and cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive Impairment. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Amnestic Mild Cognitive Impairment
- What is being tested?
- Combined Aerobic and Resistance Exercise, Stretching Exercises and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of amnestic Mild Cognitive Impairment
- available informant
- visual and auditory acuity to allow neuropsychological testing
- willingness to participate in exercise training + cognitive training for 8 months
- approval of primary provider to participate in exercise trial
Who cannot join
- current severe psychiatric disorder
- diagnosis of dementia
- history of neurological or system illness affecting CNS function
- acute illness or unstable chronic illness
- current severe cardiac disease
- inability to exercise consistently because of orthopedic or musculoskeletal problems
- morbid obesity
- inability to read, verbalize understanding and voluntarily sign the informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
The purpose of this study is examine the efficacy of a combination physical exercise and cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive Impairment.
- Conditions
- Amnestic Mild Cognitive Impairment
- Being tested
- Combined Aerobic and Resistance Exercise, Stretching Exercises, Cognitive Training
- Keywords
- Mild Cognitive Impairment, Aging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Aerobic and Resistance ExerciseBehavioural
Gym and home based aerobic and resistance exercises
Stretching ExercisesBehavioural
Gym and home based stretching exercises
Cognitive TrainingBehavioural
Group-based cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Combined Aerobic and Resistance Exercise/Cognitive Training | Active comparator | Not described Receives: Behavioral: Combined Aerobic and Resistance Exercise; Behavioral: Cognitive Training |
| Stretching Exercises/Cognitive Training | Active comparator | Not described Receives: Behavioral: Stretching Exercises; Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 28 weeks in delayed recall of a word list
Measured: Baseline, 24 weeks, 28 weeks
Change from Baseline to 28 weeks in Delayed Recall of Names-Face Task
Measured: Baseline, 24 weeks, 28 weeks
Secondary outcomes (1)
Non-Cognitive Outcomes (Depression, Sleep, Quality of Life)
Measured: Baseline, Time 2, Time 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amnestic Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, J. Kaci Fairchild, PhD, Palo Alto Veterans Institute for Research
- Investigators
- Jennifer K Fairchild, PhD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962038
- Sponsor's protocol ID
- FAI0002AGG
- Status last verified
- Apr 2018
- First submitted
- 26 Aug 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Fairchild JK, Myers J, Louras P, Jo B, McNerney MW, Hallmayer J, Yesavage J. Multimodal Exercise and Cognitive Training Program Improves Cognitive Function in Amnestic Mild Cognitive Impairment. Am J Geriatr Psychiatry. 2024 Apr;32(4):463-474. doi: 10.1016/j.jagp.2023.12.002. Epub 2023 Dec 11.
PubMed 38220592
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01962038
- Acronym / sponsor ID
- FAI0002AGG
- Conditions
- Amnestic Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- May 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is examine the efficacy of a combination physical exercise and cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive Impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Aerobic and Resistance Exercise/Cognitive Training | Active comparator | Behavioral: Combined Aerobic and Resistance Exercise, Behavioral: Cognitive Training |
| Stretching Exercises/Cognitive Training | Active comparator | Behavioral: Stretching Exercises, Behavioral: Cognitive Training |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of amnestic Mild Cognitive Impairment
- available informant
- visual and auditory acuity to allow neuropsychological testing
- willingness to participate in exercise training + cognitive training for 8 months
- approval of primary provider to participate in exercise trial
Key exclusion criteria (8 listed)
- current severe psychiatric disorder
- diagnosis of dementia
- history of neurological or system illness affecting CNS function
- acute illness or unstable chronic illness
- current severe cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Aerobic and Resistance ExerciseGym and home based aerobic and resistance exercises | Behavioural | Combined Aerobic and Resistance Exercise/Cognitive Training |
| Stretching ExercisesGym and home based stretching exercises | Behavioural | Stretching Exercises/Cognitive Training |
| Cognitive TrainingGroup-based cognitive training | Behavioural | Combined Aerobic and Resistance Exercise/Cognitive Training, Stretching Exercises/Cognitive Training |
Primary outcome
Change from Baseline to 28 weeks in delayed recall of a word list
Time frame: Baseline, 24 weeks, 28 weeks
Change from Baseline to 28 weeks in Delayed Recall of Names-Face Task
Time frame: Baseline, 24 weeks, 28 weeks
1 secondary outcome
Non-Cognitive Outcomes (Depression, Sleep, Quality of Life)
Time frame: Baseline, Time 2, Time 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Derived from this study: PubMed 38220592Fairchild JK, Myers J, Louras P, Jo B, McNerney MW, Hallmayer J, Yesavage J. Multimodal Exercise and Cognitive Training Program Improves Cognitive Function in Amnestic Mild Cognitive Impairment. Am J Geriatr Psychiatry. 2024 Apr;32(4):463-474. doi: 10.1016/j.jagp.2023.12.002. Epub 2023 Dec 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer K Fairchild, PhD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Aerobic and Resistance Exercise, Stretching Exercises and Cognitive Training in people with Amnestic Mild Cognitive Impairment, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to 28 weeks in delayed recall of a word list (time frame: Baseline, 24 weeks, 28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.