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The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions

Primary Purpose

Physical Activity, Age-related Cognitive Decline

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Aerobic Exercise
Watching television
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Activity

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-smokers
  • Do not take psychiatric drugs on a regular basis
  • Geriatric Depression Scale score less than 3
  • Mini-Mental State Examination score higher than 27
  • Healthy and able to exercise at medium intensity

Exclusion Criteria:

  • All others

Sites / Locations

  • Hille Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Highly fit older adults - Exercise

Poorly fit older adults - Exercise

Highly fit young adults - Exercise

Poorly fit young adults - Exercise

Highly fit older adults - TV

Poorly fit older adults - TV

Highly fit young adults - TV

Poorly fit young adults - TV

Arm Description

This will receive an aerobic exercise intervention

This arm will receive an aerobic exercise intervention

This arm will receive an aerobic exercise intervention

This arm will receive an aerobic exercise intervention

This arm will sit at rest and watch television

This arm will sit at rest and watch television

This arm will sit at rest and watch television

This arm will sit at rest and watch television

Outcomes

Primary Outcome Measures

Improvement in cognitive functions after exercise
This improvement will be measured through use of a vocal stroop test
Improvement in motor functions after exercise
This improvement will be measured through use of a multi-limb reaction time test

Secondary Outcome Measures

Full Information

First Posted
November 21, 2018
Last Updated
November 21, 2018
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03750812
Brief Title
The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions
Official Title
The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed study is intended to examine the connection between two types of inhibition - cognitive and motor and the connection between motor inhibitory functions and a single bout of physical exercise in the context of age and physical fitness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Age-related Cognitive Decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Highly fit older adults - Exercise
Arm Type
Active Comparator
Arm Description
This will receive an aerobic exercise intervention
Arm Title
Poorly fit older adults - Exercise
Arm Type
Active Comparator
Arm Description
This arm will receive an aerobic exercise intervention
Arm Title
Highly fit young adults - Exercise
Arm Type
Active Comparator
Arm Description
This arm will receive an aerobic exercise intervention
Arm Title
Poorly fit young adults - Exercise
Arm Type
Active Comparator
Arm Description
This arm will receive an aerobic exercise intervention
Arm Title
Highly fit older adults - TV
Arm Type
Active Comparator
Arm Description
This arm will sit at rest and watch television
Arm Title
Poorly fit older adults - TV
Arm Type
Active Comparator
Arm Description
This arm will sit at rest and watch television
Arm Title
Highly fit young adults - TV
Arm Type
Active Comparator
Arm Description
This arm will sit at rest and watch television
Arm Title
Poorly fit young adults - TV
Arm Type
Active Comparator
Arm Description
This arm will sit at rest and watch television
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
Medium-intense 60% heart rate reserve (HRR) aerobic exercise on a treadmill for 30 minutes
Intervention Type
Behavioral
Intervention Name(s)
Watching television
Intervention Description
Sitting and watching television for 30 minutes
Primary Outcome Measure Information:
Title
Improvement in cognitive functions after exercise
Description
This improvement will be measured through use of a vocal stroop test
Time Frame
One and a half hours
Title
Improvement in motor functions after exercise
Description
This improvement will be measured through use of a multi-limb reaction time test
Time Frame
One and a half hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non-smokers Do not take psychiatric drugs on a regular basis Geriatric Depression Scale score less than 3 Mini-Mental State Examination score higher than 27 Healthy and able to exercise at medium intensity Exclusion Criteria: All others
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Abu-Rukun, MA
Phone
972-54-5343199
Email
mona1986ar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Netz, PhD
Organizational Affiliation
Wingate Academic Institute
Official's Role
Study Director
Facility Information:
Facility Name
Hille Yaffe Medical Center
City
Hadera
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eias Kassem, MD
Email
eiask@hy.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions

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