NCT00979069

Brief Summary

The purpose of this study is to see if exercise can improve brain function in older adults

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 6, 2014

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

September 15, 2009

Results QC Date

September 18, 2014

Last Update Submit

November 13, 2014

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • Executive Language Functions

    The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, \& Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct

    number of correct words at pre and post separated by 12 weeks

Study Arms (2)

Aerobic Group

EXPERIMENTAL

12 weeks of aerobic exercise 3 times a week

Behavioral: Aerobic group

Control Group

NO INTERVENTION

No contact control

Interventions

Aerobic groupBEHAVIORAL

12 weeks of aerobic exercise 3 times a week

Aerobic Group

Eligibility Criteria

Age65 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Consent of participants' primary health care physicians to participate in the aerobic exercise.
  • Patients must not have participated in any consistent exercise program or experimental study for at least 3 months prior to enrollment.
  • They must be capable of providing informed consent and complying with the trial procedures.

You may not qualify if:

  • Demented as defined by the Modified Mini Mental Status Exam.
  • Unalterable travel schedules.
  • Site accessibility constraints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

  • Nocera JR, McGregor KM, Hass CJ, Crosson B. Spin exercise improves semantic fluency in previously sedentary older adults. J Aging Phys Act. 2015 Jan;23(1):90-4. doi: 10.1123/japa.2013-0107. Epub 2014 Jan 14.

    PMID: 24425525RESULT

Results Point of Contact

Title
Dr. Joe Nocera
Organization
Atlanta VAMC
joe.nocera2@va.gov
404 321 6111

Study Officials

  • Joe R Nocera, PhD

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 17, 2009

Study Start

September 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 26, 2014

Results First Posted

November 6, 2014

Record last verified: 2014-11

Locations

US(2)