Functional FitnessNCT06199661
High-Intensity Exercise in Older Adults
A study testing APEX in people with Functional Fitness and Cognitive Abilities, run by University of California, Berkeley at 1 site in United States.
Trial summary
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: 1. what is the safety and feasibility of APEX? 2. what are APEX's acute physiological effects? 3. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Fitness, Cognitive Abilities
- What is being tested?
- APEX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of San Francisco
San Francisco, California, 94118
About this study
Official title: 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?
Read more
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).
- Conditions
- Functional Fitness, Cognitive Abilities
- Being tested
- APEX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APEXBehavioural
Also called Physical exercise intervention incorporating 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.
| Study group | Role | What they receive |
|---|---|---|
| APEX | Experimental | Physical exercise intervention based on high-intensity interval training Receives: Behavioral: APEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance Rate
The number of classes attended out of eight total classes.
Measured: 4 weeks during intervention
Heart Rate
Heart rate measured in beats per minute.
Measured: 4 weeks during intervention
Functional Reach Test Distance
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.
Measured: Once 3-7 days before start of intervention and once 0-2 days after end of intervention
Timed Up-And-Go Time
The number of seconds for an individual to rise from a seated position, walk eight feet, turn around, and return to a seated position.
Measured: 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
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).
Measured: 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
The number of sit-to-stands completed in 30 seconds on a standard 17" seat-height chair with arms folded across the chest.
Measured: Once 3-7 days before start of intervention and once 0-2 days after end of intervention
Visual Search Task Accuracy
Number of correct trials
Measured: 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
Reaction time on correct trials in seconds
Measured: 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
The length of the longest sequence of random digits that a participant can correctly recall twice.
Measured: 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
The length of the longest sequence of random digits that a participant can correctly report backward twice.
Measured: 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
The length of the longest sequence of random positions that a participant can correctly recall.
Measured: 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
The length of the longest sequence of random positions that a participant can correctly report backward.
Measured: 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
Hits are the proportion of correct responses on trials when "go" is presented.
Measured: 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
Reaction times are for hit trials only (correct responses when "go" is presented) in seconds.
Measured: 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
Number of correct trials.
Measured: 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
Reaction time on correct trials in seconds.
Measured: 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
Number of correct trials.
Measured: 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
Reaction time on correct trials in seconds.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start6 Mar 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of San Francisco
- Responsible party
- Principal investigator, Maria Ivanova, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199661
- Sponsor's protocol ID
- 1884
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of a High-Intensity Exercise Intervention in Elderly Healthy Controls
- ClinicalTrials.gov ID
- NCT06199661
- Acronym / sponsor ID
- 1884
- Conditions
- Functional Fitness, Cognitive Abilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of San Francisco
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APEX | Experimental | Behavioral: APEXPhysical exercise intervention based on high-intensity interval training |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APEXAlso: Physical exercise intervention incorporating high-intensity interval trainingThree 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. | Behavioural | APEX |
Primary outcome
Attendance Rate
Time frame: 4 weeks during intervention
The number of classes attended out of eight total classes.
Heart Rate
Time frame: 4 weeks during intervention
Heart rate measured in beats per minute.
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.
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.
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).
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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
Number of correct trials.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APEX in people with Functional Fitness and Cognitive Abilities, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance Rate (time frame: 4 weeks during intervention). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.