Back to resultsSleep, Diet, Exercise and Older Persons
Primary Purpose
Cognitive Change, Cognitive Decline
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Speed Circuit Resistance Training
High-Speed Multidirectional Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Change focused on measuring Circuit Resistance Training, Yoga, Cognition
Eligibility Criteria
Inclusion Criteria: Montreal Cognitive Assessment > 23 No memory loss complaints Exclusion Criteria: Uncontrolled cardiovascular or neuromuscular disease that prevents participation in a training program Musculoskeletal impairments or injury that may impact exercise participation Visual or hearing impairments Neurological disease Stroke
Sites / Locations
- Laboratory of Neruomuscular Research and Active Aging
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High-Speed Circuit Resistance Training Group
High-Speed Multidirectional Yoga Group
Arm Description
Participants in this group will receive high-speed circuit resistance training for 12 consecutive weeks.
Participants in this group will receive high-speed multidirectional yoga for 12 consecutive weeks.
Outcomes
Primary Outcome Measures
Changes in Executive Function
Changes in executive function composite score measured by the NIH Toolbox Cognition Module
Secondary Outcome Measures
Changes in Nutritional Status
Nutritional status will be assessed by the Nutritionist Pro (Axxya Systems, Redmond, WA), a nutrition analysis software that can be used for diet 24 hour recalls. Participants will be asked to recall food intake for one weekday and one weekend day.
Changes in Sleep Quality as measured by the Pittsburg Sleep Quality Index
The Pittsburg Sleep Quality Index has seven component scores that are added to yield one global score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Full Information
NCT ID
NCT05735353
First Posted
January 12, 2023
Last Updated
September 27, 2023
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT05735353
Brief Title
Sleep, Diet, Exercise and Older Persons
Official Title
High-Speed Circuit Resistance Training vs. High-Speed Multidirectional Yoga on Changes in Cognition in Healthy Older Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To examine the impacts of a cognitive yoga program and circuit resistance training on cognitive and physical performance with nutrition and sleep as modulating factors in healthy, older adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Cognitive Decline
Keywords
Circuit Resistance Training, Yoga, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-Speed Circuit Resistance Training Group
Arm Type
Experimental
Arm Description
Participants in this group will receive high-speed circuit resistance training for 12 consecutive weeks.
Arm Title
High-Speed Multidirectional Yoga Group
Arm Type
Experimental
Arm Description
Participants in this group will receive high-speed multidirectional yoga for 12 consecutive weeks.
Intervention Type
Behavioral
Intervention Name(s)
High-Speed Circuit Resistance Training
Intervention Description
three times per week; 45 minutes per session; 12-weeks
Intervention Type
Behavioral
Intervention Name(s)
High-Speed Multidirectional Yoga
Intervention Description
two times per week; 60 minutes per session; 12-weeks
Primary Outcome Measure Information:
Title
Changes in Executive Function
Description
Changes in executive function composite score measured by the NIH Toolbox Cognition Module
Time Frame
Baseline, 16 weeks
Secondary Outcome Measure Information:
Title
Changes in Nutritional Status
Description
Nutritional status will be assessed by the Nutritionist Pro (Axxya Systems, Redmond, WA), a nutrition analysis software that can be used for diet 24 hour recalls. Participants will be asked to recall food intake for one weekday and one weekend day.
Time Frame
Baseline, 16 weeks.
Title
Changes in Sleep Quality as measured by the Pittsburg Sleep Quality Index
Description
The Pittsburg Sleep Quality Index has seven component scores that are added to yield one global score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Time Frame
Baseline, 16 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Montreal Cognitive Assessment > 23
No memory loss complaints
Exclusion Criteria:
Uncontrolled cardiovascular or neuromuscular disease that prevents participation in a training program
Musculoskeletal impairments or injury that may impact exercise participation
Visual or hearing impairments
Neurological disease
Stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Signorile, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Neruomuscular Research and Active Aging
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Sleep, Diet, Exercise and Older Persons
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