NCT02787655

Brief Summary

The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability. To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of executive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 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

February 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

6.2 years

First QC Date

May 25, 2016

Results QC Date

May 6, 2020

Last Update Submit

November 12, 2020

Conditions

Keywords

Aging

Outcome Measures

Primary Outcomes (1)

  • Change Executive Language Functions (Category Verbal Fluency)

    The Category Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89. For Category Verbal Fluency, participants are asked to generate words from a category (e.g., colors) within 60 seconds. A higher change score represents better performance on the outcome.

    change from pre and post separated by 12 weeks

Study Arms (2)

Aerobic Exercise + Cognitive Training Group

EXPERIMENTAL

Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program

Behavioral: Aerobic exercise + Cognitive Training Group

Cognitive Training Only Group

ACTIVE COMPARATOR

Cognitive Training Only Group. For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises

Behavioral: Cognitive training Only

Interventions

stationary bicycling

Aerobic Exercise + Cognitive Training Group

20 minutes of cognitive training using Mindfit program

Cognitive Training Only Group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right handed
  • English speaking
  • Aged 18 to 89
  • Sedentary as defined by \< 120 min/week of aerobic exercise over prior 3 months
  • Non-demented (MMSE 24)

You may not qualify if:

  • Severe diabetes requiring insulin
  • Cognitive-executive function deficit (MoCA \< 26)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

  • Nocera J, Crosson B, Mammino K, McGregor KM. Changes in Cortical Activation Patterns in Language Areas following an Aerobic Exercise Intervention in Older Adults. Neural Plast. 2017;2017:6340302. doi: 10.1155/2017/6340302. Epub 2017 Mar 6.

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Joe Nocera
Organization
Atl VA

Study Officials

  • Joe R. Nocera, PhD

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 1, 2016

Study Start

February 1, 2013

Primary Completion

April 1, 2019

Study Completion

June 1, 2019

Last Updated

November 16, 2020

Results First Posted

June 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations