Mild Cognitive ImpairmentNCT03824639
Exercise Training to Improve Cognitive Function
A study testing Structured exercise and Health Education in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This project is assessing the feasibility of a novel home-based exercise intervention to improve episodic memory in individuals with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Structured exercise and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Amnestic MCI
- Ability to use a telephone without assistance
Who cannot join
- Angina Pectoris
- History of myocardial infarction within 6 months
- History of ventricular dysrhythmia requiring current therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
This project is assessing the feasibility of a novel home-based exercise intervention to improve episodic memory in individuals with mild cognitive impairment.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Structured exercise, Health Education
- Keywords
- Mild cognitive impairment, exercise therapy, patient adherence
- Medical subject headings
- Cognitive Dysfunction, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exerciseBehavioural
Exercise instruction and encouragement
Health EducationBehavioural
Provision of general information about a variety of health topics
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Structured exercise Receives: Behavioral: Structured exercise |
| Control group | Active comparator | Health education Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months
Secondary outcomes (1)
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.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start23 Apr 2019
- Primary completion31 May 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David Sparrow, DSc, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824639
- Sponsor's protocol ID
- E2545-P
- Status last verified
- Jun 2023
- First submitted
- 29 Jan 2019
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training to Improve Cognitive Function
- ClinicalTrials.gov ID
- NCT03824639
- Acronym / sponsor ID
- E2545-P
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild cognitive impairment, exercise therapy, patient adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Structured exerciseStructured exercise |
| Control group | Active comparator | Behavioral: Health EducationHealth education |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Amnestic MCI
- Ability to use a telephone without assistance
Key exclusion criteria (3 listed)
- Angina Pectoris
- History of myocardial infarction within 6 months
- History of ventricular dysrhythmia requiring current therapy
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 |
|---|---|---|
| Structured exerciseExercise instruction and encouragement | Behavioural | Exercise group |
| Health EducationProvision of general information about a variety of health topics | Behavioural | Control group |
Primary outcome
Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months
Time frame: 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.
1 secondary outcome
Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David Sparrow, DSc principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise and Health Education in people with Mild Cognitive Impairment, run by VA Office of Research and Development 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 2 inclusion and 3 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 14 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024.