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Clinical Trials/NCT06199661
NCT06199661
Completed
Not Applicable

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

University of California, Berkeley1 site in 1 country4 target enrollmentMarch 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Fitness
Sponsor
University of California, Berkeley
Enrollment
4
Locations
1
Primary Endpoint
Number of Repetitions in 30-Second Chair Stand Test
Status
Completed
Last Updated
2 years ago

Overview

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:

  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).
Registry
clinicaltrials.gov
Start Date
March 6, 2023
End Date
June 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Ivanova

Research Scientist

University of California, Berkeley

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 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.

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.

Attendance Rate

Time Frame: 4 weeks during intervention

The number of classes attended out of eight total classes.

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).

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.

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.

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

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.

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.

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.

Study Sites (1)

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