NCT01264614

Brief 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. It is hypothesized that there will be a significant improvement in brain function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 11, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

December 21, 2010

Results QC Date

December 2, 2014

Last Update Submit

March 9, 2015

Conditions

Keywords

exerciseneuropsychologicaldementiaAlzheimer's Diseasemild cognitive impairmentstrengthMCIADEEGneurophysiologicalgrowth factorcognitive declineexecutive function

Outcome Measures

Primary Outcomes (6)

  • 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).

    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).

    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).

    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).

    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).

    Baseline and 3 months

  • Neurophysiological Function Pre- & Post- Intervention

    Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention

    Baseline and 3 months

Study Arms (2)

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.

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.

Behavioral: Strengthening exercise

Interventions

3 months of 3-5 times per week of low-intensity exercises using a chair and small weights

Also known as: Strong Bones Program
Early stage dementiaNormative older adults

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stratton VA Medical Center

Albany, New York, 12208, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cognitive DysfunctionDementiaAlzheimer DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesBehavior

Results Point of Contact

Title
Cay Anderson-Hanley, PhD
Organization
UNION COLLEGE

Study Officials

  • Cay Anderson-Hanley, PhD

    Union College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 22, 2010

Study Start

December 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

March 11, 2015

Results First Posted

March 11, 2015

Record last verified: 2015-03

Locations