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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01167400
Other study ID # HS1259
Secondary ID 64449
Status Completed
Phase N/A
First received July 20, 2010
Last updated September 4, 2014
Start date July 2008
Est. completion date August 2010

Study information

Verified date September 2014
Source Union College, New York
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Exercise has been linked to cognitive health, but few older adults exercise at recommended levels. Cybercycling may provide additional cognitive benefits due to increased motivation to ride the interactive 3D tours. Participants will be randomly assigned to three months of either cybercycling or traditional stationary biking; and they will complete comprehensive evaluations before and after exercise. Older adults are expected to show significant neuropsychological, physiological and behavioral gains.


Description:

The purpose of this study is to test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercyle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- age 50+

- able to participate in cycling

- physician permission

Exclusion Criteria:

- unstable heart condition

- physician denial

- neurological condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Cybercycling
exercising on a videogame-enhanced interactive 3D stationary bicycle for 3 months, 3-5x/wk
Traditional exercise
exercising on a traditional stationary bike for 3 months, 3-5x/wk

Locations

Country Name City State
United States Beltrone Living Center Colonie New York
United States Highpointe Apartments Malta New York
United States Glen Eddy Niskayuna New York
United States Prestwick Chase Saratoga Springs New York
United States Wesley Health Care (Woodlawn and Embury) Saratoga Springs New York
United States Westview Apartments Saratoga Springs New York
United States Kingsway Village Schenectady New York
United States Schaffer Heights Schenectady New York

Sponsors (2)

Lead Sponsor Collaborator
Union College, New York Skidmore College

Country where clinical trial is conducted

United States, 

References & Publications (1)

Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cognitive function after three months of exercise. Cognitive function, especially executive function, will be assessed before and after three months of either cybercycling or traditional exercise biking. Neuropsychological tests will assess: cognitive flexibility and simultaneous processing(i.e., Stroop, Digits Backwards, and Trails Difference Score). 3 months No
Secondary Weight Weight and other physiological factors will be assessed before and after 3 months of exercise. 3 months No
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