Cognitive DeclineNCT01264614

Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults

A study testing Strengthening exercise in people with Cognitive Decline and Dementia, run by Union College, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the effects of low-intensity strengthening exercise on the brain (thinking and processing speed) for patients with early dementia, compared with normative older adults. Participants will engage in 3 months of exercise 3-5 times per week using a chair and small weights. Read more about this study

Who is it for?: Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for: Cognitive Decline, Dementia, Alzheimer's Disease
What is being tested?: Strengthening exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Dec 2010to Apr 2011
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 55 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult Day Program Participants with early dementia able to consent or assent with surrogate permission
Control participants (55-100+ yo) able to participate at location with doctor permission

Who cannot join

history of significant TBI, psychiatric condition, substance abuse, physical conditions that preclude participation in cognitive testing or strengthening exercises

Trial locations and contacts

1 site in 1 country.

United States1 site

Stratton VA Medical Center
Albany, New York, 12208

Other trials in United States

About this study

Official title: Neuropsychological and Neuroimaging Effects of Strengthening Exercise for Early Dementia and Normative Older Adults

Read the detailed description

Objective(s): This study will evaluate the neuropsychological and neurophysiological effects of low-intensity strengthening exercise for patients with early dementia, compared with normative older adults.
Research Design: This is a quasi-experimental design in which change over time as a result of the exercise intervention will be compared with change over time seen in a normative sample.
Methodology: The aim is to enroll 12 participants with early dementia and 12 normative controls, all who are interested in starting a strengthening exercise program. Neuropsychological evaluation, resting electroencephalography (EEG), and event-related potentials (ERP) data collection will commence prior to the start of exercise. Participants will participate in an exercise class 2-3x/wk for three months. Repeat neuropsychological, EEG, and ERP evaluations will occur at the conclusion of three months of exercise. The exercises consist of low-intensity exercises, using a chair and small weights. A leader trained in the Tufts University exercise model will conduct the classes.
Findings: The investigators hypothesize a positive impact of exercise on neuropsychological function, especially performance on tasks requiring executive functions. This change will be compared with performance of normative controls who also exercise. Changes in brain function will be explored using EEG and ERP, and results are expected to be similar to prior research examining older adult exercisers which shows improvement in function.

Conditions: Cognitive Decline, Dementia, Alzheimer's Disease, Mild Cognitive Impairment
Being tested: Strengthening exercise
Keywords: exercise, neuropsychological, dementia, Alzheimer's Disease, mild cognitive impairment, strength, MCI, AD, EEG, neurophysiological, growth factor, cognitive decline, executive function
Medical subject headings: Cognitive Dysfunction, Dementia, Alzheimer Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Strengthening exerciseBehavioural
Also called Strong Bones Program
3 months of 3-5 times per week of low-intensity exercises using a chair and small weights

Study groups in NCT01264614
Study group	Role	What they receive
Early stage dementia	Experimental	Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week. Participants engaged in a strengthening exercise program three to five times per week for 10 weeks. Receives: Behavioral: Strengthening exercise
Normative older adults	Active comparator	Normative older adults with no known neurological condition. Participants engaged in a strengthening exercise program three to five times per week for 10 weeks. Receives: Behavioral: Strengthening exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Stroop Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).
Measured: Baseline and 3 months
Digits Backwards Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).
Measured: Baseline and 3 months
Color Trails Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).
Measured: Baseline and 3 months
Fuld Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).
Measured: Baseline and 3 months
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy \& Delayed possible score range is 0-36 points).
Measured: Baseline and 3 months
Neurophysiological Function Pre- & Post- Intervention
Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention
Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Apr 2011

First posted22 Dec 2010 (estimated)
Study startDec 2010
Primary completionApr 2011
Study completionApr 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cognitive DeclineStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01264614
Sponsor's protocol ID: MIRB#00663
Status last verified: Mar 2015
First submitted: 21 Dec 2010
Last updated: 11 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Yerokhin V, Anderson-Hanley C, Hogan MJ, Dunnam M, Huber D, Osborne S, Shulan M. Neuropsychological and neurophysiological effects of strengthening exercise for early dementia: a pilot study. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2012;19(3):380-401. doi: 10.1080/13825585.2011.628378. Epub 2011 Dec 2.
PubMed 22136405

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cognitive Decline trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuropsychological and Neuroimaging Effects of Strengthening Exercise for Early Dementia and Normative Older Adults
ClinicalTrials.gov ID: NCT01264614
Acronym / sponsor ID: MIRB#00663
Conditions: Cognitive Decline, Dementia, Alzheimer's Disease, Mild Cognitive Impairment
Keywords: exercise, neuropsychological, dementia, Alzheimer's Disease, mild cognitive impairment, strength, MCI, AD
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Union College, New YorkUniversity, hospital or other
Collaborators: US Department of Veterans Affairs
Study start: Dec 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 22 Dec 2010 (estimated)
Results: Posted 11 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective(s): This study will evaluate the neuropsychological and neurophysiological effects of low-intensity strengthening exercise for patients with early dementia, compared with normative older adults.
Research Design: This is a quasi-experimental design in which change over time as a result of the exercise intervention will be compared with change over time seen in a normative sample.
Methodology: The aim is to enroll 12 participants with early dementia and 12 normative controls, all who are interested in starting a strengthening exercise program. Neuropsychological evaluation, resting electroencephalography (EEG), and event-related potentials (ERP) data collection will commence prior to the start of exercise. Participants will participate in an exercise class 2-3x/wk for three months. Repeat neuropsychological, EEG, and ERP evaluations will occur at the conclusion of three months of exercise. The exercises consist of low-intensity exercises, using a chair and small weights. A leader trained in the Tufts University exercise model will conduct the classes.
Findings: The investigators hypothesize a positive impact of exercise on neuropsychological function, especially performance on tasks requiring executive functions. This change will be compared with performance of normative controls who also exercise. Changes in brain function will be explored using EEG and ERP, and results are expected to be similar to prior research examining older adult exercisers which shows improvement in function.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Early stage dementia	Experimental	Behavioral: Strengthening exerciseIndividuals with early stage dementia who attended a Adult Day Care Program at least twice a week. Participants engaged in a strengthening exercise program three to five times per week for 10 weeks.
Normative older adults	Active comparator	Behavioral: Strengthening exerciseNormative older adults with no known neurological condition. Participants engaged in a strengthening exercise program three to five times per week for 10 weeks.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adult Day Program Participants with early dementia able to consent or assent with surrogate permission
Control participants (55-100+ yo) able to participate at location with doctor permission

Key exclusion criteria (1 listed)

history of significant TBI, psychiatric condition, substance abuse, physical conditions that preclude participation in cognitive testing or strengthening exercises

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
Strengthening exerciseAlso: Strong Bones Program3 months of 3-5 times per week of low-intensity exercises using a chair and small weights	Behavioural	Early stage dementia, Normative older adults

Primary outcome

Stroop Test Performance From Pre- to Post-intervention
Time frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).
Digits Backwards Test Performance From Pre- to Post-intervention
Time frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).
Color Trails Test Performance From Pre- to Post-intervention
Time frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).
Fuld Test Performance From Pre- to Post-intervention
Time frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Time frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy \& Delayed possible score range is 0-36 points).
Neurophysiological Function Pre- & Post- Intervention
Time frame: Baseline and 3 months
Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention

Results and safety

Results posted to the registry on 11 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early Stage Dementia	13	12
Normative Older Adults	9	7

Primary outcome: Stroop Test Performance From Pre- to Post-intervention

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: Time to complete (seconds)

Measure	Early Stage Dementia n = 12	Normative Older Adults n = 7
Stroop C pre	137.67 (102.30)	56.17 (10.34)
Stroop C post	116.51 (64.44)	55.13 (11.08)

Population analysed: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.

Primary outcome: Digits Backwards Test Performance From Pre- to Post-intervention

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: Points

Measure	Early Stage Dementia n = 12	Normative Older Adults n = 7
Digits Backward pre	4.10 (1.73)	5.50 (2.59)
Digits Backward post	3.90 (1.10)	6.83 (2.71)

Primary outcome: Color Trails Test Performance From Pre- to Post-intervention

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: Time to complete (seconds)

Measure	Early Stage Dementia n = 12	Normative Older Adults n = 7
Color Trails 2 pre	250.00 (186.45)	124.00 (67.97)
Color Trails 2 post	259.01 (197.63)	96.11 (19.97)

Primary outcome: Fuld Test Performance From Pre- to Post-intervention

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: Points

Measure	Early Stage Dementia n = 12	Normative Older Adults n = 7
Fuld Semantic Recall pre	10.60 (3.66)	18.80 (8.76)
Fuld Semantic Recall post	10.60 (4.27)	18.60 (5.86)
Fuld Immediate Recall pre	2.90 (2.38)	6.60 (1.34)
Fuld Immediate Recall post	4.40 (1.65)	7.60 (1.52)
Fuld Delayed Recall pre	2.60 (2.41)	8.40 (1.14)
Fuld Delayed Recall post	4.50 (2.72)	8.20 (.45)

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early Stage Dementia	0 of 13 (0%)	0 of 13 (0%)	Not reported
Normative Older Adults	0 of 9 (0%)	0 of 9 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22136405Yerokhin V, Anderson-Hanley C, Hogan MJ, Dunnam M, Huber D, Osborne S, Shulan M. Neuropsychological and neurophysiological effects of strengthening exercise for early dementia: a pilot study. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2012;19(3):380-401. doi: 10.1080/13825585.2011.628378. Epub 2011 Dec 2.

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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.

Cay Anderson-Hanley, PhD principal investigator

Union College

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Strengthening exercise in people with Cognitive Decline and Dementia, run by Union College, New York 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 1 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 11 Mar 2015. 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 11 Mar 2015). 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?

Stroop Test Performance From Pre- to Post-intervention (time frame: Baseline and 3 months). The study lists 6 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 NCT01264614, 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 11 Mar 2015.