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:

  1. what is the safety and feasibility of APEX?
  2. what are APEX's acute physiological effects?
  3. what is APEX's effects on functional fitness?
  4. 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • San Francisco, California, United States, 94118
        • University of San Francisco

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: APEX
Physical exercise intervention based on high-intensity interval training
Behavioral: APEX
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:
  • Physical exercise intervention incorporating high-intensity interval training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Berkeley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of San Francisco

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings