NCT05542758

Brief Summary

This study will examine differences in a 12 week high-intensity interval training regimen. The Total Body HIIT program incorporates a resistance (circuit) and an anaerobic (bike) component in older adults. The specific objectives focus on examining cardiovascular endurance, neuromuscular function, and muscle architecture.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

September 6, 2022

Last Update Submit

July 15, 2024

Conditions

Keywords

geriatricshigh-intensity interval trainingrehabilitation

Outcome Measures

Primary Outcomes (10)

  • Change in 6-Min Walk Test performance from baseline to following HIIT intervention

    The 6MWT will be assessed by tallying the number of laps a participant is able walk on a 100 ft straight path. Partially completed laps will be measured and added to the total distance. Participants will be allowed to take standing rest breaks, if necessary, but the time will continue during all rest breaks. Participants will be instructed to "cover as much ground as you can in 6 minutes".

    change from baseline to immediately after the HIIT intervention

  • Change in Voluntary Muscle Strength Tests (Isokinetics) from baseline to following HIIT intervention

    Isokinetic strength testing on the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii muscles at slow (60° per second), medium (180° per second), fast (300° per second) and fast unweighted (500° per second) speeds with three maximal repetitions performed for each speed to determine voluntary peak torque production capabilities at each speed using a dynamometer. During the strength testing assessments, each subject will be asked to push or pull "as hard as possible" against a lever arm on the dynamometer until the limb reaches the end of the range of motion.

    change from baseline to immediately after the HIIT intervention

  • Change in Voluntary Muscle Strength Tests (Isometrics) from baseline to following HIIT intervention

    Isometric strength of the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii muscles will be assessed using a dynamometer. For maximal voluntary isometric contraction assessments, participants will complete two, 3- to 4-second MVICs of the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii. Participants will be instructed to "push or pull as hard and fast as possible" and hold against the dynamometer to achieve max voluntary torque and rate of torque development.

    change from baseline to immediately after the HIIT intervention

  • Change in Evoked Muscle Function Assessments: Evoked Peak Force from baseline to following HIIT intervention

    Evoked muscle function will be assessed using electrical stimulation delivered to the superficial quadriceps femoris via a cathode-anode arrangement, with the cathode probe pressed into the femoral triangle over the femoral nerve and the anode fixed over the greater trochanter. Manual stepwise increases in stimulation will be completed until max contraction is achieved. Once max contraction is achieved, a maximal, single and doublet stimulus will be administered. The single stimulation will be used to elicit a max M-wave amplitude (defined as the max M-wave peak-to-peak amplitude). A doublet stimulus will be used to drive the muscle to maximal contraction capability to investigate the muscle contractile capability. To examine maximal contractile capacity, torque produced from the quadriceps femoris from the dynamometer during the first 50 ms, evoked peak force.

    change from baseline to immediately after the HIIT intervention

  • Change in Evoked Muscle Function Assessments: Evoked Peak Rate of Force Development from baseline to following HIIT intervention

    Evoked muscle function will be assessed using electrical stimulation delivered to the superficial quadriceps femoris via a cathode-anode arrangement, with the cathode probe pressed into the femoral triangle over the femoral nerve and the anode fixed over the greater trochanter. Manual stepwise increases in stimulation will be completed until max contraction is achieved. Once max contraction is achieved, a maximal, single and doublet stimulus will be administered. The single stimulation will be used to elicit a max M-wave amplitude (defined as the max M-wave peak-to-peak amplitude). A doublet stimulus will be used to drive the muscle to maximal contraction capability to investigate the muscle contractile capability. To examine maximal contractile capacity, evoked peak rate of force development 0-50ms will be recorded resulting from a maximal doublet stimulus from the quadriceps femoris.

    change from baseline to immediately after the HIIT intervention

  • Change in Rate of Muscle Activation from baseline to following HIIT intervention

    To examine muscle activation, surface electromyographic (sEMG) signals collected during the voluntary and evoked muscle contractions will be collected from the quadriceps femoris (vastus lateralis, rectus femoris, and vastus medialis muscles), hamstrings (biceps femoris muscle), biceps brachii, and triceps brachii muscles. Peak muscle activation will be assessed as the peak sEMG amplitude. Rate of muscle activation will be assessed in the first 50 ms following muscle activation onset.

    change from baseline to immediately after the HIIT intervention

  • Change in Voluntary Electromechanical Delay from baseline to following HIIT intervention

    To examine muscle activation, surface electromyographic (sEMG) signals collected during the voluntary and evoked muscle contractions will be collected from the quadriceps femoris (vastus lateralis, rectus femoris, and vastus medialis muscles), hamstrings (biceps femoris muscle), biceps brachii, and triceps brachii muscles. Peak muscle activation will be assessed as the peak sEMG amplitude. Voluntary electromechanical delay will be calculated from the time difference from the onset of sEMG to the onset of force.

    change from baseline to immediately after the HIIT intervention

  • Change in Ultrasound-based Muscle Architecture: Cross-sectional Area from baseline to following HIIT intervention

    Ultrasound images of the vastus lateralis, rectus femoris, biceps femoris, vastus medialis, biceps brachii, and triceps brachii will be obtained. Muscle cross-sectional area for each muscle will be assessed.

    change from baseline to immediately after the HIIT intervention

  • Change in Ultrasound-based Muscle Architecture: Echo Intensity from baseline to following HIIT intervention

    Ultrasound images of the vastus lateralis, rectus femoris, biceps femoris, vastus medialis, biceps brachii, and triceps brachii will be obtained. Echo intensity for each muscle will be assessed.

    change from baseline to immediately after the HIIT intervention

  • Change in Muscle Biopsy-based Muscle Architecture from baseline to following HIIT intervention

    Muscle biopsies will be collected to determine myofiber size from the quadriceps femoris (i.e., vastus lateralis). After necessary biopsy preparations, the distribution of myofiber type and size will be determined within each sample.

    change from baseline to immediately after the HIIT intervention

Secondary Outcomes (8)

  • Change in V02 peak from baseline to following HIIT intervention

    change from baseline to immediately after the HIIT intervention

  • Change in Gait Speed from baseline to following HIIT intervention

    change from baseline to immediately after the HIIT intervention

  • Change in Functional Lower Body Strength from baseline to following HIIT intervention

    change from baseline to immediately after the HIIT intervention

  • Change in Functional Upper Body Strength from baseline to following HIIT intervention

    change from baseline to immediately after the HIIT intervention

  • Change in Balance: Center of Pressure Excursion from baseline to following HIIT intervention

    change from baseline to immediately after the HIIT intervention

  • +3 more secondary outcomes

Study Arms (1)

Total Body HIIT Program

EXPERIMENTAL

This Total Body HIIT program (circuit and bike training) will involve 3 sessions per week (35-40 min on nonconsecutive days) progressed across the 12 weeks. All session will be lead by undergraduate exercise science students or doctor of physical therapy students and supervised by a physical therapist.

Other: Total Body HIIT Program

Interventions

One repetition maximums (1RM) and body weight (BW) will be recorded at prior to and at 6 weeks to tailor the program. The circuit will be completed twice during each session and the exercises will include: squats, medicine ball forward chest throws, medicine ball overhead throw, farmers walk, seated shoulder press, seated row sitting on a fitness ball, aerobic riser step-ups, foot ladder drills, and twisting medicine ball passes. The anaerobic component will be completed once during a session and on a stationary bike. The progression of exercise:rest seconds will be 20:40 for Weeks 1-4, 30:30 for Weeks 5-8, and 40:20 for Weeks 9-12. Each session will start with a 5 minute warm up and end with a 5-minute cool down. Participants will be given real time feedback about heart rate (goal range: 85-95% HRmax) and exercise movement velocity. Participants will be encouraged to surpass the velocity of the previous repetition.

Total Body HIIT Program

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • Physical independent (Barthel Index)
  • Physician clearance to participate
  • No medication changes in previous 30 days
  • No structured resistance training program in previous 6 months

You may not qualify if:

  • Contraindications to high-intensity exercise39 (PAR-Q Questionnaire)
  • Severe mental impairment (\<18 on Montreal Cognitive Assessment)
  • Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the 12-week high-intensity intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 15, 2022

Study Start

March 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Locations