Adapted Taekwondo on Health Status in Older Women

NCT ID: NCT05275140

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-01-30

Brief Summary

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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.

Detailed Description

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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 iv) 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.

Conditions

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Healthy People Programs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

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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.

Group Type EXPERIMENTAL

Physical activity

Intervention Type OTHER

Combat sports and exercise

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.

Group Type ACTIVE_COMPARATOR

Physical activity

Intervention Type OTHER

Combat sports and exercise

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.

Group Type ACTIVE_COMPARATOR

Physical activity

Intervention Type OTHER

Combat sports and exercise

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical activity

Combat sports and exercise

Intervention Type OTHER

Other Intervention Names

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Physical fitness

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica del Maule

OTHER

Sponsor Role lead

Responsible Party

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Pablo Valdés-Badilla

Academic-Researcher at the Department of Physcial Activity Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pablo Valdés-Badilla, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica del Maule

Locations

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Poliderportivo San Clemente

San Clemente, Maule Region, Chile

Site Status

Countries

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Chile

References

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Related Links

Access external resources that provide additional context or updates about the study.

http://www.mindep.cl/secciones/151

Ministerio del Deporte. Encuesta Nacional de Hábitos de Actividad Física y Deporte 2018 en Población de 18 años y más.

http://repository.openpolytechnic.ac.nz/handle/11072/1510

International standards for anthropometric assessment. Wellington: ISAK, 2012.

Other Identifiers

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11220035

Identifier Type: -

Identifier Source: org_study_id

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