NCT04120792

Brief Summary

This study will determine the effects of simultaneous exercise and cognitive training on cognitive function in healthy older adults. Specifically, this study will compare the use of a tablet-based cognitive training system while exercising with exercise alone, cognitive training alone, and a neutral control condition on cognition.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

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

May 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
Last Updated

October 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

October 4, 2019

Last Update Submit

October 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in cognitive function during dual-task test at 12 weeks

    Performance on serial subtraction during dual-task walking.

    Baseline and 12-weeks

Secondary Outcomes (7)

  • Change from baseline in stride length during dual-task test

    Baseline, 6 weeks, 12 weeks

  • Change from baseline in stride duration during dual-task test

    Baseline, 6 weeks, 12 weeks

  • Change from baseline in stride velocity during dual-task test

    Baseline, 6 weeks, 12 weeks

  • Change from baseline in stride length variability during dual-task test

    Baseline, 6 weeks, 12 weeks

  • Change from baseline in stride duration variability during dual-task test

    Baseline, 6 weeks, 12 weeks

  • +2 more secondary outcomes

Other Outcomes (10)

  • Change from baseline in Wechsler Adult Intelligence Scale-IV Digit Span total score

    Baseline, 6 weeks, 12 weeks

  • Change from baseline in Wechsler Adult Intelligence Scale-IV Coding total score

    Baseline, 6 weeks, 12 weeks

  • Change from baseline in Wechsler Adult Intelligence Scale-IV Letter-Number Sequencing total score

    Baseline, 6 weeks, 12 weeks

  • +7 more other outcomes

Study Arms (4)

Simultaneous exercise and cognitive training

EXPERIMENTAL

Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.

Behavioral: Simultaneous exercise and cognitive training

Exercise training

ACTIVE COMPARATOR

Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.

Behavioral: Exercise training

Cognitive training

ACTIVE COMPARATOR

Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.

Behavioral: Cognitive Training

Neutral Video

ACTIVE COMPARATOR

Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.

Behavioral: Neutral video

Interventions

Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.

Simultaneous exercise and cognitive training

Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.

Exercise training

Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.

Cognitive training
Neutral videoBEHAVIORAL

Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.

Neutral Video

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy, age 60-74, and a written statement from their primary care physician indicating that they are able to participate in the 12-week exercise program.

You may not qualify if:

  • Subjects will be excluded from participating in the study if they express significant concerns about their memory or declines in other cognitive abilities, if they are not English speaking, or if they have histories of significant major neurological, psychiatric, or medical disorder or injury that would affect cognitive function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Raichlen DA, Bharadwaj PK, Nguyen LA, Franchetti MK, Zigman EK, Solorio AR, Alexander GE. Effects of simultaneous cognitive and aerobic exercise training on dual-task walking performance in healthy older adults: results from a pilot randomized controlled trial. BMC Geriatr. 2020 Mar 2;20(1):83. doi: 10.1186/s12877-020-1484-5.

MeSH Terms

Interventions

Cognitive TrainingExercise

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gene Alexander

    University of Arizona

    PRINCIPAL INVESTIGATOR
  • David Raichlen

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 9, 2019

Study Start

May 1, 2015

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

October 9, 2019

Record last verified: 2019-05