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Completed

NCT Number: NCT06199661

High-Intensity Exercise in Older Adults

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).

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Key information

Conditions

Functional Fitness Cognitive Abilities

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of San Francisco

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APEX

Behavioral

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

Primary outcomes

  1. Attendance Rate

    Time frame: 4 weeks during intervention

    The number of classes attended out of eight total classes.

  2. Heart Rate

    Time frame: 4 weeks during intervention

    Heart rate measured in beats per minute.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • University of San Francisco

Registry information

Official study title

Feasibility and Efficacy of a High-Intensity Exercise Intervention in Elderly Healthy Controls

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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