- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05735353
Sleep, Diet, Exercise and Older Persons
September 27, 2023 updated by: Joseph Signorile, University of Miami
High-Speed Circuit Resistance Training vs. High-Speed Multidirectional Yoga on Changes in Cognition in Healthy Older Adults.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33147
- Laboratory of Neruomuscular Research and Active Aging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-Speed Circuit Resistance Training Group
Participants in this group will receive high-speed circuit resistance training for 12 consecutive weeks.
|
three times per week; 45 minutes per session; 12-weeks
|
|
Experimental: High-Speed Multidirectional Yoga Group
Participants in this group will receive high-speed multidirectional yoga for 12 consecutive weeks.
|
two times per week; 60 minutes per session; 12-weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Executive Function
Time Frame: Baseline, 16 weeks
|
Changes in executive function composite score measured by the NIH Toolbox Cognition Module
|
Baseline, 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Nutritional Status
Time Frame: Baseline, 16 weeks.
|
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.
|
Baseline, 16 weeks.
|
|
Changes in Sleep Quality as measured by the Pittsburg Sleep Quality Index
Time Frame: Baseline, 16 weeks.
|
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.
|
Baseline, 16 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Signorile, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2023
Primary Completion (Actual)
July 30, 2023
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
January 12, 2023
First Submitted That Met QC Criteria
February 9, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- 20221319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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