NCT06199661

Brief 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:

  • 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 13, 2023

Last Update Submit

December 29, 2023

Conditions

Outcome Measures

Primary Outcomes (18)

  • Attendance Rate

    The number of classes attended out of eight total classes.

    4 weeks during intervention

  • Heart Rate

    Heart rate measured in beats per minute.

    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.

    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.

    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).

    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.

    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

    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

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

Study Arms (1)

APEX

EXPERIMENTAL

Physical exercise intervention based on high-intensity interval training

Behavioral: APEX

Interventions

APEXBEHAVIORAL

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.

Also known as: Physical exercise intervention incorporating high-intensity interval training
APEX

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of San Francisco

San Francisco, California, 94118, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

December 13, 2023

First Posted

January 10, 2024

Study Start

March 6, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

January 10, 2024

Record last verified: 2023-12

Locations