NCT04880057

Brief Summary

This study will investigate the effect of agility training on executive function, dual task walking and brain activation in healthy adults. Participants (N=70) will be randomly assigned to resistance+aerobic training group (RAeT) or agility training group (AT). Participants in RAeT (n=35) will receive 15-minute lower extremity workout first and then 25-minute moderate intensity (60-75% predicted maximal heart rate) aerobic training. Participants in AT (n=35) will do the agility exercise program consisting of technical drills, pattern running and reactive agility training. The intervention will be twelve-time group intervention (3-5persons) in four weeks, 50 minutes per session (5-minute warmup, 40- minute main training, 5-minute cool-down). Participants will undergo three measurement time points (pre-, post-intervention and one month follow-up). Outcome measures will include executive function (N-back test, stroop test and Wisconsin card sort test), single and dual task walking performance and brain activity (fNIRS on prefrontal cortex, supplementary motor area and premotor cortex). Two-way analysis of variance (ANOVA) with Tukey post-hoc test will be used to examine the group x time interaction on three outcome measures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

May 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

1.4 years

First QC Date

May 3, 2021

Last Update Submit

June 9, 2022

Conditions

Keywords

brain activitymotor performancedual task walkingexecutive functionagility training

Outcome Measures

Primary Outcomes (24)

  • Executive function- N-back task (3-back)

    N-back task (3-back) is used to measure working memory

    Change from Baseline score at 3 weeks

  • Executive function- N-back task (3-back)

    N-back task (3-back) is used to measure working memory

    Change from Baseline score at 7 weeks

  • Executive function- Stroop test

    Stroop test is used to measure the selective attention and conflict resolution.

    Change from Baseline score at 3 weeks

  • Executive function- Stroop test

    Stroop test is used to measure the selective attention and conflict resolution.

    Change from Baseline score at 7 weeks

  • Executive function- Wisconsin card sort test

    Wisconsin card sort test is an easy way to assess the ability of mental set shifting.

    Change from Baseline score at 3 weeks

  • Executive function- Wisconsin card sort test

    Wisconsin card sort test is an easy way to assess the ability of mental set shifting.

    Change from Baseline score at 7 weeks

  • Single walking performance- Walking speed

    The unit is length (cm) per seconds

    Change from Baseline cadence at 3 weeks

  • Single walking performance- Walking speed

    The unit is length (cm) per seconds

    Change from Baseline cadence at 7 weeks

  • Single walking performance- Cadence

    The unit is steps per minutes

    Change from Baseline cadence at 3 weeks

  • Single walking performance- Cadence

    The unit is steps per minutes

    Change from Baseline cadence at 7 weeks

  • Single walking performance- Stride length

    The unit is cm

    Change from Baseline cadence at 3 weeks

  • Single walking performance- Stride length

    The unit is cm

    Change from Baseline cadence at 7 weeks

  • Single walking performance- Step duration

    The unit is seconds

    Change from Baseline cadence at 3 weeks

  • Single walking performance- Step duration

    The unit is seconds

    Change from Baseline cadence at 7 weeks

  • Dual task walking performance- Walking speed

    The unit is length (cm) per seconds

    Change from Baseline cadence at 3 weeks

  • Dual task walking performance- Walking speed

    The unit is length (cm) per seconds

    Change from Baseline cadence at 7 weeks

  • Dual task walking performance- Cadence

    The unit is steps per minutes

    Change from Baseline cadence at 3 weeks

  • Dual task walking performance- Cadence

    The unit is steps per minutes

    Change from Baseline cadence at 7 weeks

  • Dual task walking performance- Stride length

    The unit is cm

    Change from Baseline cadence at 3 weeks

  • Dual task walking performance- Stride length

    The unit is cm

    Change from Baseline cadence at 7 weeks

  • Dual task walking performance- Step duration

    The unit is seconds

    Change from Baseline cadence at 3 weeks

  • Dual task walking performance- Step duration

    The unit is seconds

    Change from Baseline cadence at 7 weeks

  • Dual task walking performance- the correct rates of arithmetic task

    The participants will be instructed to subtract by 7 serially from a 3-digit number while walking at their fastest speed in dual task walking condition

    Change from Baseline cadence at 3 weeks

  • Dual task walking performance- the correct rates of arithmetic task

    The participants will be instructed to subtract by 7 serially from a 3-digit number while walking at their fastest speed in dual task walking condition

    Change from Baseline cadence at 7 weeks

Secondary Outcomes (18)

  • Brain activities over premotor cortex- Executive function

    Change from Baseline at 3 weeks

  • Brain activities over premotor cortex- Executive function

    Change from Baseline at 7 weeks

  • Brain activities over supplementary motor area- Executive function

    Change from Baseline at 3 weeks

  • Brain activities over supplementary motor area- Executive function

    Change from Baseline at 7 weeks

  • Brain activities over primary motor cortex- Executive function

    Change from Baseline at 3 weeks

  • +13 more secondary outcomes

Study Arms (2)

Resistance+Aerobic training group

ACTIVE COMPARATOR

Resistance+Aerobic training group (RAeT) RAeT includes resistance training (RT) program and aerobic training (AeT) program.

Other: Resistance+Aerobic training

Agility training group

EXPERIMENTAL

Agility training

Other: Agility training

Interventions

The RT focuses on lower extremity workout, including leg press, hamstring curls, and calf raises. The participants start with intensity at 12 RM and finished with intensity at 8 RM after 3 weeks. There are 8 repetitions, 2 sets for each action. It will take 15 minutes to complete RT. The AeT is composed by cycling on stationary bikes in the first week, stepping on steppers in 2nd week, and running on treadmills in the last week. Participants are asked to wear a portable heart rate monitor throughout the experiments. They have to maintain their heart rates in 60%-75% of predicted maximal heart rate (moderate intensity exercise), which has been shown to be benefit on cognition\[3\]. It took the participants 25 minutes to complete AeT.

Also known as: RAeT
Resistance+Aerobic training group

AT program consists of three parts: technical drills, pattern running and reactive agility training. There will be nine sessions over 3 weeks and progress the intensity, complexity or velocity every week.

Also known as: AT
Agility training group

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (1) age between 20 to 30 years, and (2) ability to walk 20 meters independently without an assistive device.

You may not qualify if:

  • (1) overweight (BMI\>24), (2) any smoker or alcohol abusers, (3) suffering from chronic diseases that loss of control, (4) Unstable physiological conditions, such as abnormal signs like high blood pressure, headache, dyspnea, fever, etc., (5) any neuromuscular or cardiopulmonary diseases that would influent the exercise performance, and (6) suffering from diseases which exercises are their contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Central Study Contacts

Yanci Liu, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 10, 2021

Study Start

August 2, 2021

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

June 13, 2022

Record last verified: 2022-06

Locations