High-Intensity Exercise in Older Adults

Functional Fitness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06199661
• Other study ID #: 1884
• Status: Completed
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2023
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Abilities
• Functional Fitness

Intervention

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.

Locations

Country	Name	City	State
United States	University of San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	University of San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance Rate	The number of classes attended out of eight total classes.	4 weeks during intervention
Primary	Heart Rate	Heart rate measured in beats per minute.	4 weeks during intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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