TKD&Aging: Adapted Taekwondo on Health Status in Older Women

Sponsor

Universidad Católica del Maule (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05275140

Collaborator

(none)

Enrollment

Arms

20.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The main aim of this project is to analyze and compare the effects of an adapted taekwondo program with respect to multi-component training and walking program on health status in independent older women. The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach. The sample will be 64 women without health problems, between 60 and 65 years old and who decide to participate voluntarily. The participants will be randomized and distributed into four groups: experimental group 1 (adapted taekwondo), experimental group 2 (multi-component training), experimental group 3 (walking program) and a control group (no intervention). Assessments will consist of: systolic and diastolic blood pressure with automatic blood pressure monitor; lipid profile with the Cardiochek meter; frequency of food consumption with the modified dietary habits survey for older people; body composition by direct anthropometry and bioimpedance; cognitive status with the survey of memory, phonetic fluency and temporal-spatial orientation (in Spanish, MEFO); brain activity by means of surface electromyography; quality of life perception with the Health Survey Short Form (SF-36) version 2; physical-functional fitness with the Senior Fitness Test; handgrip strength with a hydraulic dynamometer; and postural balance with a force platform. Assessments will be performed before the 16-week intervention and after the intervention. To analyze the pre-and post-intervention results, repeated measures ANOVA will be applied for group factors (EG1 vs. EG2 vs. EG3 vs. CG) and time (pre-and post-intervention) with the Bonferroni post-hoc test; the reliability of the evaluations will be verified by means of the coefficient of intraclass correlation, and the inter-individual variability to the intervention (responders vs. non-responders) will be calculated using the technical error of measurement. The expected results indicate that adapted taekwondo produces significantly greater effects and a more favorable inter-individual response in cognitive status, brain activity, quality of life perception and postural balance compared to a multi-component training and walking program, in addition to producing similar effects at the group and inter-individual level for blood pressure, lipid profile, frequency of food consumption, body composition and physical-functional fitness in independent older women.

Condition or Disease	Intervention/Treatment	Phase
Healthy People Programs	Other: Physical activity	N/A

Detailed Description

Design The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach. Sixty-four women over 60 years of age will be invited to participate in the study voluntarily and then be electronically randomized (https://www.randomizer.org/) and assigned to either experimental group 1 (EG1, n = 16; adapted taekwondo), experimental group 2 (EG2, n = 16; multi-component training), experimental group 3 (EG3, n = 16, walking program) or the control group (CG, n = 16; no intervention).

Sample The sample calculation indicates that the ideal number of participants per group is 16. According to previous research, for this calculation, an average difference of 3.46 repetitions (chair stand test) was used as the minimum difference required for substantial clinical relevance, with a standard deviation of 3.38 repetitions, considering an alpha level of 0.05 with 90% power and an expected loss of 15%. The inclusion criteria for the sample will be: i) older women aged between 60 and 65 years old; ii) presenting the ability to understand and follow instructions in a contextualized way through simple commands; iii) independent, that is, have a score equal to or greater than 43 points in the Preventive Medicine Exam for the Older People (in Spanish, EMPAM) of the Ministry of Health (31); and

complying with at least 85% attendance at the sessions scheduled for interventions. Regarding the exclusion criteria, the following will be considered: i) having any disabling disease; ii) those women who have musculoskeletal injuries or who are undergoing physical rehabilitation treatment that prevents their normal physical performance; and iii) those who have permanent or temporary contraindications to perform PA.

All participants will be informed of the scope of the research and will sign an informed consent that authorizes the use of the information for scientific purposes. In addition, the research protocol will follow the CONSORT guidelines, will be reviewed by the Scientific Ethics Committee of the Universidad Católica del Maule and will be developed following what is stated in the Declaration of Helsinki for work with human beings.

Before starting the intervention, during the last week of July 2022 (for one week), older women will be evaluated in the variables considered for the research, later, from the first week of August to the last week of November 2022 (16 weeks) will participate in designated training programs. After the intervention (first week of December 2022), for one week, the older women will undergo the same initial assessments.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The assessments will be scheduled one week before and after the intervention with a team of evaluators who will not have information about the training groups, nor will the participants know their identities. That is, a double-blind shield

Primary Purpose:

Treatment

Official Title:

Effectiveness of Adapted Taekwondo, Multi-component Training and Walking on Health Status in Independent Older Women: a Randomized Controlled Trial With Group and Inter-individual Analysis

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Mar 14, 2023

Anticipated Study Completion Date :

Mar 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 1 (adapted taekwondo) The general structure of the adapted taekwondo will include a 10-min warm-up consisting of joint mobility exercises and low intensity aerobic work, then, for 40-min of the adapted taekwondo (will consist of non-contact activities, distributed in 10-min of basic postures and specific movements with the upper limbs and 20-min of lower limb movements performed individually and in pairs with and without the implementation of taekwondo. In addition, choreographies or forms (sequence of arm and leg movements that simulate an imaginary combat) specific to this modality were adapted to the characteristics of older women for 10-min; and will be developed to finish with the cool down for 10-min through dynamic and static flexibility exercises.	Other: Physical activity Combat sports and exercise Other Names: Physical fitness
Active Comparator: Experimental group 2 (multi-component training) The general structure of the multi-component training will include a 10-min warm-up consisting of joint mobility exercises and low intensity aerobic work, then, for 40-min of the multi-component training (distributed work in a circuit, which includes resistance training focused on the large muscles of the upper limbs and lower limbs combined with exercises aimed at cardiorespiratory fitness, agility and postural control, using elastic bands, poles, 2-kg medicine balls and chairs). The training volume will start (the first 4-weeks) with 3 sets of 10 repetitions per muscular exercise with a 2-min rest period between sets, performing slow movements of two seconds in concentric contraction and four seconds in eccentric contraction. Between weeks 5 to 8, the volume will increase to 4 sets of 10 repetitions per muscular exercise with 2-min of rest between sets.	Other: Physical activity Combat sports and exercise Other Names: Physical fitness
Active Comparator: Experimental group 3 (walking program) The walking program will be distributed in three weekly sessions of 45- to 60-min every other day, for 16-weeks (48 sessions). The general structure of the protocol will include a 5-min warm-up consisting of joint mobility and flexibility exercises. Next, the main part will be developed for 30- to 45-min (increased by 5-min every 4-weeks) consisting of walking on flat ground, touring the jogging circuit that the University has on campus, and ending with 5-min cool down through dynamic and static flexibility exercises.	Other: Physical activity Combat sports and exercise Other Names: Physical fitness
No Intervention: Control group The control group, the individuals will participate in the assessments (initial and final) and will be asked to maintain their usual activities. An undergraduate student (support personnel) will contact the participants by telephone (once a week) to consult them about their health status and monitor their activities. At the end of the intervention period, the control group will be invited to participate in a physical activity program that will be developed at the University based on the results of this project.

Outcome Measures

Primary Outcome Measures

Change from Baseline Blood Pressure at 16 weeks [2 weeks]
The systolic and diastolic blood pressure will be obtained with an automatic pressure monitor (08A, CONTEC, Germany). The participants will be evaluated considering at least 10-min of previous rest in a sitting position, with the back and arms supported and the legs without crossing, emptying the urinary bladder if necessary. In addition, women will be asked not to do exercise, smoke, drink alcohol or coffee at least 30-min before the measurements. The first assessment will be taken in both arms to identify the arm with the highest blood pressure, and then two assessments will be taken in the arm with the highest blood pressure (usually the dominant) adding a third assessment if the difference between the measurements is greater than 5 mmHg.
Change from Lipid Profile at 16 weeks [2 weeks]
This will be determined in a fasting condition of at least 12-h; the extraction of 5 ml of capillary blood will be carried out by a nurse considering the necessary safeguards in the Human Performance Laboratory with the use of a meter (Cardiochek PA, USA) to determine total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, cholesterol without HDL, and total cholesterol/HDL cholesterol ratio.
Change from Frequency of Food Consumption at 16 weeks [2 weeks]
The aim of the survey is to measure the eating habits of older people and is made up of two areas of self-application. The first is composed of 12 items with a minimum score of 1 and a maximum of 5 per question (Likert scale), which indicates the frequency of healthy habits, such as the frequency of consumption of recommended food groups, ranging from not consuming (1 point) up to the suggested day/week servings (5 points), with a score of the responses that varies from 12 to 60 points (higher value, better eating habits). The second area consists of 7 items, foods or food groups identified as promoters of chronic non-communicable diseases (sugary drinks, alcohol, fried foods, fast food, sweet snacks, coffee), and a negative eating habit is added, such as adding salt to meals without tasting them; reaching a value that ranges from 7 to 33 points (higher values indicate worse eating habits).
Change from Anthropometric measurements at 16 weeks [2 weeks]
The following anthropometric measurements will be obtained: i) body weight in kg with a digital scale (Seca 769, Germany; Accuracy of 0.1 kg); ii) bipedal height in cm with a stadiometer (Seca 220, Germany; Accuracy of 0.1 cm). Weight and height will be combined to report BMI in kg/m^2.
Change from Body Composition (muscle mass) at 16 weeks [2 weeks]
The following body composition (muscle mass) will be obtained: i) diameters (biacromial, transverse thorax, anteroposterior thorax, bi-iliocrestid, humeral, femoral) in cm with an anthropometer (Rosscraft Campbell 20; Accuracy of 0.1 mm); ii) perimeters (head, arm relaxed, arm flexed in tension, forearm maximum, mesosternal thorax, minimum waist, maximum hip, maximum thigh, medial thigh, maximum calf) in cm using an inextensible measuring tape (Seca 201, Germany); and iii) skinfolds (tricipital, subscapular, supraspinal, abdominal, medial thigh, calf) in mm with a caliper (Harpenden, England; Accuracy of 0.2 mm.
Change from Body Composition (fat mass) at 16 weeks [2 weeks]
The following body composition (fat mass) will be obtained: i) diameters (biacromial, transverse thorax, anteroposterior thorax, bi-iliocrestid, humeral, femoral) in cm with an anthropometer (Rosscraft Campbell 20; Accuracy of 0.1 mm); ii) perimeters (head, arm relaxed, arm flexed in tension, forearm maximum, mesosternal thorax, minimum waist, maximum hip, maximum thigh, medial thigh, maximum calf) in cm using an inextensible measuring tape (Seca 201, Germany); and iii) skinfolds (tricipital, subscapular, supraspinal, abdominal, medial thigh, calf) in mm with a caliper (Harpenden, England; Accuracy of 0.2 mm.
Change from Body Composition (fat mass) by bioimpedance at 16 weeks [2 weeks]
The following body composition (bioimpedance), the percentage of fat mass will be obtained using eight electrode tetrapolar bioimpedance (InBody 570®, Body Composition Analyzers, South Korea).
Change from Body Composition (fat-free mass) by bioimpedance at 16 weeks [2 weeks]
The following body composition (bioimpedance), the percentage of fat-free mass will be obtained using eight electrode tetrapolar bioimpedance (InBody 570®, Body Composition Analyzers, South Korea).
Change from Cognitive Status at 16 weeks [2 weeks]
This will be evaluated using the memory, phonetic fluency and temporal-spatial orientation survey (in Spanish, MEFO) (34), which aims to determine the level of cognitive impairment in older people. This survey classifies the participants into three levels: without cognitive impairment, with mild cognitive impairment, or with cognitive impairment. The advantage of the MEFO is that the level of schooling does not have an influence; its application is simple and brief (34). The MEFO assesses deferred free recall, phonetic fluency with the letter P, and temporal-spatial orientation; furthermore, it has high sensitivity in the fields described and is validated for use with older people in Chile (34).
Change from Brain Activity at 16 weeks [2 weeks]
This will be analyzed through a 64+8 channel surface electromyography system (active-Two from BioSemi, The Netherlands) using a mapping task and a reaction time task, with the aim of measuring spatial and visual-abilities motor skills, in addition to the planning index of the participants, following previous recommendations (35).
Change from Quality of Life Perception at 16 weeks [2 weeks]
This will be obtained using the Health Survey Short Form (SF-36) version 2, which measures the attributes of eight health dimensions: physical function, physical role, body pain, general health, vitality, social function, emotional role and mental health (36). Each dimension is made up of a series of questions that together give a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status) (36).
Change from Physical-Functional Fitness (strenght of the lower body) at 16 weeks [2 weeks]
This will be evaluated with the Senior Fitness Test, which allows evaluation of great reliability and easy application (37). The chair stand test to assess the strength of the lower body, counting the number of repetitions made in 30s.
Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks [2 weeks]
This will be evaluated with the Senior Fitness Test, which allows evaluation of great reliability and easy application (37). The arm curl test to assess the strength on the upper body, using a 3lb (women) and 5lb (men) dumbbell, counting the number of repetitions made in 30s.
Change from Physical-Functional Fitness (aerobic fitness) at 16 weeks [2 weeks]
This will be evaluated with the Senior Fitness Test, which allows evaluation of great reliability and easy application (37). The 2-minute step to assess aerobic fitness, recording the number of knee elevations.
Change from Physical-Functional Fitness (flexibility of the lower-body) at 16 weeks [2 weeks]
This will be evaluated with the Senior Fitness Test, which allows evaluation of great reliability and easy application (37). The chair sit-&-reach test to assess the flexibility of the lower-body, measured in cm.
Change from Physical-Functional Fitness (flexibility on the upper-body) at 16 weeks [2 weeks]
This will be evaluated with the Senior Fitness Test, which allows evaluation of great reliability and easy application (37). The back scratch test to assess flexibility on the upper-body, measured in cm.
Change from Physical-Functional Fitness (agility and dynamic balance) at 16 weeks [2 weeks]
This will be evaluated with the Senior Fitness Test, which allows evaluation of great reliability and easy application (37). The timed up-and-go test to assess agility and dynamic balance, surrounding a cone at 8ft (2.44m) and recording time in seconds.
Change from Handgrip Strength at 16 weeks [2 weeks]
The handgrip strength will be measured with a hydraulic dynamometer (Camry, model EH101, China)
Change from Postural Balance at 16 weeks [2 weeks]
The postural balance will be obtained with a force platform (ArtOficio Ltda., Chile).

Secondary Outcome Measures

Sociodemographic Assessments [1 week]
Age (years), academic level (primary, secondary, bachelor, master, PhD), civil status (married, separated, widow, single, others).

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Older women aged between 60 and 65 years old.
Presenting the ability to understand and follow instructions in a contextualized way through simple commands.
Independent, that is, have a score equal to or greater than 43 points in the Preventive Medicine Exam for the Older People (in Spanish, EMPAM) of the Ministry of Health (31).
Complying with at least 85% attendance at the sessions scheduled for interventions.

Exclusion Criteria:

Having any disabling disease.
Those women who have musculoskeletal injuries or who are undergoing physical rehabilitation treatment that prevents their normal physical performance.
Those who have permanent or temporary contraindications to perform physical activity.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universidad Católica del Maule

Investigators

Principal Investigator: Pablo Valdés-Badilla, PhD, Universidad Católica del Maule

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Pablo Valdés-Badilla, Academic-Researcher at the Department of Physcial Activity Sciences, Universidad Católica del Maule

ClinicalTrials.gov Identifier:

NCT05275140

Other Study ID Numbers:

11220035

First Posted:

Mar 11, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pablo Valdés-Badilla, Academic-Researcher at the Department of Physcial Activity Sciences, Universidad Católica del Maule

Study Results

No Results Posted as of Mar 31, 2022