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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04760054
Other study ID # 21174
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 24, 2021
Est. completion date December 15, 2021

Study information

Verified date August 2022
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators' study is designed to test whether brief exposure to a martial arts-based intervention (a coordinative, partnered training exercise known as "Hubod"), can improve cognitive function to a greater degree than aerobic exercise of a similar intensity.


Description:

This three-arm randomized controlled trial will compare the feasibility, and possibly the effects, of a martial arts intervention vs. aerobic exercise vs. an attentional (non-exercise) control condition. The martial arts intervention will consist of a partnered, coordinated sensitivity exercise drawn from south-east Asian martial arts, known as Hubod (also spelt hubud and hubad). Participants will be trained in the fundamental movements of Hubod. Participants will also have the history, cultural significance, risks and purpose of Hubod explained to them throughout the study. The aerobic exercise comparator group will use a stationary bicycle to match the duration and exercise intensity of the martial arts intervention group, under the supervision of trained research assistants. Participants will also receive information on aerobic exercise and the Physical Activity Guidelines for Americans 2020. Participants in the Videos Control group will watch educational videos on martial arts, physical fitness and exercise for the same duration as the intervention and exercise comparison groups. All participants, regardless of group, will be assessed for martial arts and exercise experience once at baseline. All participants will be tested for cognitive performance change. Baseline and follow-up computerized cognitive testing will take place at a specified testing facility and psychosocial questionnaires will be delivered remotely via a Qualtrics-powered survey. After baseline testing, participants will attend 5 sessions, approximately 30 minutes each. Follow-up testing will be administered more than 48 hours post-intervention to minimize established acute adaptive responses to exercise. The investigators hypothesize the martial arts training intervention group will exhibit a greater increase in performance of cognitive tasks when compared less complex movement patterns involved in the aerobic exercise group or videos control group.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date December 15, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Men and Women between the ages of 18-45 years who are low active Exclusion Criteria: - Anyone who is physically active (=30 minutes, 3 or more times/week, for the last 3 months) and/or a regular practitioner of martial arts and/or highly complex coordination drills such as dance performance or contact improvisation (=30 minutes, 3 or more times/week, for the last 3 months). - Anyone with serious chronic medical conditions that would preclude them from participating without a physician present, or anyone with a risk of seizure, or anyone having psychiatric and/or neurological disorders. - Pregnant women. - Anyone incapable of performing the following movements at a moderate intensity- sitting, standing, kicking, pulling, pushing, bending one's elbows or bending one's knees. - Anyone who scores 1 or more on the Physical Activity Readiness Questionnaire - Anyone refusing or unwilling to be randomized into either of the conditions. - Anyone who cannot commit to both 45 minute testing sessions or the five 30-minute training sessions.

Study Design


Intervention

Behavioral:
HUBOD
Participants in the intervention group will attend 5 separate training sessions instructing them in Hubod. The Hubod exercise is a partnered coordination drill involving moves derived from numerous martial arts, most often seen in the Filipino martial art of Kali. Participants will aim to reach a level of comfort and competency in the basic, non-competitive aspects of the Hubod exercise by the end of their participation in this intervention.
Active Comparator
Participants in the active comparator group will attend 5 separate training sessions. Each session will involve a 5 minute warmup of joint mobilization exercises and mild pedaling on the bicycle before the main effort of continuously using the bicycle for approximately 20 minutes. The session finishes with a 5 minute cooldown period and light stretch. Heartrate will be monitored regularly in order to prevent this exercise exceeding the relative intensity of the Martial Arts intervention group. Participants will be allowed to talk and interact with research assistants in order to keep socialization effects consistent across groups.
Control Condition
Participants in this group will attend 5 separate training sessions. Each session will involve watching educational videos on martial arts techniques and training methods from a sedentary position. Participants will be allowed to talk and interact with research assistants in order to keep socialization effects consistent across groups.

Locations

Country Name City State
United States Exercise, Technology, and Cognition Laboratory - Louise Freer Hall 284 Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Perceived Mental Fatigue Questionnaire A novel, 7-item assessment of current state of mental fatigue will be used (example items include "My thoughts easily wander," "My thinking requires effort.") The scales response ranges from 1 (not true at all) to 5 (very true) and all items are summed and averaged whereby higher scores indicated greater mental fatigue. Participants will be assessed at baseline and in the week immediately following the two-week intervention period; also delivered immediately prior to and following each of the five intervention training sessions.
Other Grip strength task A dynamometer will be used to assess grip strength. Under supervision, participants will engage in two trials per hand (unless each trial results in an increasing or identical score, at which point a third trial will be used). The highest score, as well as an average of the two highest scores, will be recorded as measures of grip strength from this task. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Stair-climb task To assess mobility, participants will be asked to walk up and down a single 15-step staircase. After explanation and demonstration of the task, participants will be asked to safely descend as quickly as possible, without skipping stairs, running or using the railing for assistance. The same will be asked for participants during stair ascension. Performance will be recorded as total time (seconds) to complete stair ascent and descent. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other One-leg balance task Balance will be assessed by asking participants to stand on one leg for a maximum of 30 seconds. Participants may not use any assistance and performance will be recorded as balance time (in seconds) without touching the floor or their base leg with their elevated leg. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Dot task Agility will be assessed with a timed, choreographed sequence of steps on a dotted floor mat (positioned in an X-pattern). Performance will be based on how quickly (measured in seconds) they can perform the prescribed, choreographed sequence. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Godin Leisure-Time Exercise Questionnaire This is a 4-item self report assessment of physical activity. Respondents are asked the frequency they engage in strenuous, moderate and mild activity for 15 minutes or more as part of their free time. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Brief Self Control Scale 13-item self-reported measure of individual differences in control. Items are scored on a 1-5 likert scale (1 = not at all like me, 5 = Very much like me). Scores are totaled and the mean average calculated to be used in final analysis. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Multidimensional Outcomes Expectations for Exercise Scale The Multidimensional Outcome Expectancies for Exercise Scale (MOEES; Wójcicki, White, & McAuley, 2009) is a 15-item questionnaire that has three subscales: physical outcome expectancies, social outcome expectancies, and self-evaluative outcome expectancies. The MOEES assesses an individual's beliefs or expectations about the benefits of regular exercise. Each question is based on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Each subscale is scored by summing the total items, with higher scores being indicative of higher outcome expectations for exercise. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Exercise Motivations Inventory-2 The Exercise Motivations Inventory-2 will be used to assess the type of reasons one has for participating in an exercise program (and their relative strength). Only subscales with items involving appearance, strength/endurance, nimbleness and positive health will be used. Composite scores will be computed for each subscale by summing and averaging responses. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other State Trait Anxiety Inventory Trait anxiety, or one's disposition to respond with anxiety to situations perceived as threatening will be assessed with the State Train Anxiety Inventory. It comprises 20 items (11 direct worded and 9 reverse worded), and respondents answer according to how they generally feel; responses are provided on a frequency scale ranging from 1 (almost never) to 4 (almost always). Composite scores are computed by summing and averaging items. Participants will complete this questionnaire immediately prior and immediately following each of the five intervention training sessions.
Other Hospitalized Anxiety and Depression Scale The established Hospitalized Anxiety and Depression scale consists of 14 questions, and utilizes a 0 to 3-point Likert scale. Oddly numbered questions comprise the Anxiety subscale and evenly numbered questions comprise the Depression subscale. Six items are reversely coded. The sum of item scores in these questions are the final outcome scores per subscale, with 0-7 considered normal, 8-10 considered borderline abnormal and 11-21 considered abnormal. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Physical Activity Self Regulation Questionnaire A 12-item questionnaire will be used to assess one's usage of self-regulatory strategies that promote physical activity including cognitive and behavioral strategies. Items are scored 1 (Never) to 5 (Very often). Our prior work has determined that this scale is not uni-dimensional across samples. We will therefore use an empirically-driven factor analysis to determine the best set of items to include in the mean composite. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Self-efficacy for overcoming barriers to exercise A 13-item questionnaire will be used to assess self-efficacy specific to possible barriers affecting exercise adherence. All items will be answered on a 0-100% Likert scale in increments of 10%. Prior research suggests that this may not be a uni-dimensional scale and therefore a composite will be based on a 4-item composite. These four items best reflect participants' confidence to self-regulate in the face of actual barriers, including exercising regularly in the face of bad weather, while on vacation, without encouragement, and when under personal stress. These four items will be averaged to generate our main outcome of interest, and the remaining nine items will be assessed for exploratory purposes. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Other Martial arts experience A novel questionnaire will assess prior martial arts experience. For example, "Do you have any experience with martial arts or combat training? This includes any combat training as part of military or police service." Individual item averages and frequencies will be used to describe the sample. Participants will be assessed once, at baseline.
Primary Digit Symbol Substitution task Processing speed and working memory cognitive task using numbers and symbols. Participants will be presented with multiple rows of symbols, each one corresponding to a number on a 1-9 scale and they will have two minutes to correctly match (in sequential order) as many symbols to their numbers as possible. Performance is computed by adding the number of symbols correctly-matched within the allotted time. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Primary n-2back memory task Working memory cognitive task involving a sequence of shapes briefly appearing on a computer screen. If the shape on screen is identical to the shape two stages before, the participant will press the 'match' key. If they are not identical, the participant should do nothing. Performance is derived by the number of correctly-matched shapes in the sequence and calculating the average reaction time across the trials. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Secondary Matrix Reasoning Task Participants will be required to identify patterns among objects in an incomplete, 3x3 matrix, according to row and column, and to select the correct object that completes the remaining empty box from a list of potential objects. Performance will be assessed from the number of correct responses within the allotted time. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Secondary Trail-Making Test The trail-making test is a global cognition and spatial awareness assessment involving two parts. Respondents must complete each part as quickly as possible using a single, continuous pencil-drawn line. For Trails part A, the numbers 1-26 are randomly arranged on a sheet of paper and respondents are required to connect the numbers, in order, using a single pencil line. The pencil is not allowed to leave the paper until the task is complete. The same is true for Trails part B, but the sequence is now numero-alphabetic (1, A, 2, B, 3, C and so on). The task is complete when the participant reaches the end of the sequence. Performance will be measured by how long it takes the participant to complete parts A and B. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
Secondary Flanker Task The Flanker task paradigm assesses inhibition control. The task utilizes pictures and symbols and is delivered using an iPad. Participants will be required to correctly identify, as fast as possible, the direction a central arrow among a set of surrounding arrows that are pointing in either congruent or incongruent directions. Performance will be assessed using average reaction time responses and accuracy across the congruent and incongruent trials. Inhibition percent interference will be calculated using the formula ((incongruent reaction time - congruent reaction time)/congruent reaction time) * 100. Participants will be assessed at baseline and in the week immediately following the two-week intervention period.
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