- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06199661
High-Intensity Exercise in Older Adults
December 29, 2023 updated by: Maria Ivanova, University of California, Berkeley
Feasibility and Efficacy of a High-Intensity Exercise Intervention in Elderly Healthy Controls
The goal of this interventional study was to test the high-intensity interval training called Aphasia Physical Exercise (APEX) in healthy older adults. The main questions it aimed to answer were:
- what is the safety and feasibility of APEX?
- what are APEX's acute physiological effects?
- what is APEX's effects on functional fitness?
- what is APEX's effects on cognition?
Participants underwent:
- Baseline testing session (#1) with cognitive measures only (a week before the Pre-exercise session);
- Pre-exercise session (#2) with maximum oxygen consumption and heart rate assessment, functional fitness and cognitive measures (3-7 days before the start of the exercise program);
- APEX program, two APEX classes per week for four weeks (eight classes in total);
- Post-exercise session (#3), functional fitness and cognitive measures, (0-2 days after the end of the exercise program).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
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
-
-
California
-
San Francisco, California, United States, 94118
- University of San Francisco
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-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Between the ages of 50 and 80
- Ambulatory and community-dwelling
- Able to travel to University of San Francisco for weekly exercise classes
- No serious underlying health or neurological conditions
Exclusion Criteria:
- Inability to complete physical function assessment or inability to do a chair stand without using hands
- Use of antidiabetic medications
- Use of testosterone supplement or replacement
- Clinical disorder precluding/interfering with participation or assessments (identified by Physical Activity Readiness Questionnaire (PAR-Q+)), including: unstable angina, arrhythmia, uncontrolled hypertension, end stage renal disease on hemodialysis, lower extremity amputation or paralysis, neurological conditions causing functional or pronounced cognitive impairments, active malignancy except for non-melanomatous skin cancers
- Previous neurological history such as stroke, traumatic brain injury, multiple sclerosis, long-term pre-stroke seizures, Parkinson's, Alzheimer's, etc.
- Unable to provide consent
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: APEX
Physical exercise intervention based on high-intensity interval training
|
Three phases: warm-up, high-intensity interval training (HIIT) phase, cool-down.
A 10-minute warm-up included deep breathing meditation and dynamic joint mobility exercises.
Then, a 40-minute strength and balance workout in HIIT format with five different high-intensity (HI) exercises interspersed with five different postural stability recovery exercises.
The HI intervals focused on enhancing cardiovascular fitness, muscle strength, and motor performance.
The recovery intervals incorporated balance and mobility exercises.
The HI exercises lasted 30 seconds for the first three weeks and then increased to 45 seconds in the fourth week while the recovery exercises lasted 60 seconds throughout the entire intervention.
The HIIT phase was repeated three times in the 40 minute block.
Lastly, a 10-minute cooldown consisting of standing and seated exercises similar to the warm-up.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance Rate
Time Frame: 4 weeks during intervention
|
The number of classes attended out of eight total classes.
|
4 weeks during intervention
|
|
Heart Rate
Time Frame: 4 weeks during intervention
|
Heart rate measured in beats per minute.
|
4 weeks during intervention
|
|
Functional Reach Test Distance
Time Frame: Once 3-7 days before start of intervention and once 0-2 days after end of intervention
|
The distance in inches of an individual's forward reach with one arm while maintaining a standing position with feet flat on the floor at hip width.
|
Once 3-7 days before start of intervention and once 0-2 days after end of intervention
|
|
Timed Up-And-Go Time
Time Frame: Once 3-7 days before start of intervention and once 0-2 days after end of intervention
|
The number of seconds for an individual to rise from a seated position, walk eight feet, turn around, and return to a seated position.
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Once 3-7 days before start of intervention and once 0-2 days after end of intervention
|
|
Number of Steps in 2-minute Step Test
Time Frame: Once 3-7 days before start of intervention and once 0-2 days after end of intervention
|
The number of right knee raises completed in two minutes while marching in place and raising each knee to a point midway between the patella (kneecap) and iliac crest (top hip bone).
|
Once 3-7 days before start of intervention and once 0-2 days after end of intervention
|
|
Number of Repetitions in 30-Second Chair Stand Test
Time Frame: Once 3-7 days before start of intervention and once 0-2 days after end of intervention
|
The number of sit-to-stands completed in 30 seconds on a standard 17" seat-height chair with arms folded across the chest.
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Once 3-7 days before start of intervention and once 0-2 days after end of intervention
|
|
Visual Search Task Accuracy
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
Number of correct trials
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Visual Search Task Reaction Time
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
Reaction time on correct trials in seconds
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Forward Digit Span
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
The length of the longest sequence of random digits that a participant can correctly recall twice.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Backward Digit Span
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
The length of the longest sequence of random digits that a participant can correctly report backward twice.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Forward Spatial Span
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
The length of the longest sequence of random positions that a participant can correctly recall.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Backward Spatial Span
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
The length of the longest sequence of random positions that a participant can correctly report backward.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Go/No-Go Task Hits
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
Hits are the proportion of correct responses on trials when "go" is presented.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Go/No-Go Task Reaction Times
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
Reaction times are for hit trials only (correct responses when "go" is presented) in seconds.
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Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Flanker Task Accuracy
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
Number of correct trials.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Flanker Task Reaction Times
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
Reaction time on correct trials in seconds.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Stroop Task Accuracy
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
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Number of correct trials.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
|
Stroop Task Reaction Times
Time Frame: Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
Reaction time on correct trials in seconds.
|
Once 10-14 days before start of intervention, once 3-7 days before start of intervention, and once 0-2 days after end of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
March 6, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
June 1, 2023
Study Registration Dates
First Submitted
December 13, 2023
First Submitted That Met QC Criteria
December 29, 2023
First Posted (Actual)
January 10, 2024
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 1884
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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