Clinical trial NCT05275140: Adapted Taekwondo on Health Status in Older Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy People Programs
Keywords: Public health
Physical Activity
Older adults
Active aging
Combat sports.
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 56
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
Primary purpose: PREVENTION

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Blood Pressure at 16 weeks
timeFrame: 2 weeks
measure: Change from Lipid Profile at 16 weeks
timeFrame: 2 weeks
measure: Change from Frequency of Food Consumption at 16 weeks
timeFrame: 2 weeks
measure: Change from Anthropometric measurements at 16 weeks
timeFrame: 2 weeks
measure: Change from Body Composition (muscle mass) at 16 weeks
timeFrame: 2 weeks
measure: Change from Body Composition (fat mass) at 16 weeks
timeFrame: 2 weeks
measure: Change from Body Composition (fat mass) by bioimpedance at 16 weeks
timeFrame: 2 weeks
measure: Change from Body Composition (fat-free mass) by bioimpedance at 16 weeks
timeFrame: 2 weeks
measure: Change from Cognitive Status at 16 weeks
timeFrame: 2 weeks
measure: Change from Brain Activity at 16 weeks
timeFrame: 2 weeks
measure: Change from Quality of Life Perception at 16 weeks
timeFrame: 2 weeks
measure: Change from Physical-Functional Fitness (strenght of the lower body) at 16 weeks
timeFrame: 2 weeks
measure: Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks
timeFrame: 2 weeks
measure: Change from Physical-Functional Fitness (aerobic fitness) at 16 weeks
timeFrame: 2 weeks
measure: Change from Physical-Functional Fitness (flexibility of the lower-body) at 16 weeks
timeFrame: 2 weeks
measure: Change from Physical-Functional Fitness (flexibility on the upper-body) at 16 weeks
timeFrame: 2 weeks
measure: Change from Physical-Functional Fitness (agility and dynamic balance) at 16 weeks
timeFrame: 2 weeks
measure: Change from Handgrip Strength at 16 weeks
timeFrame: 2 weeks
measure: Change from Postural Balance at 16 weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Sociodemographic Assessments
timeFrame: 1 week
Other outcomes:
Locations:
city: San Clemente
country: Chile
facility: Poliderportivo San Clemente
state: Region Del Maule
Study officials:
affiliation: Universidad Católica del Maule
name: Pablo Valdés-Badilla, PhD
role: PRINCIPAL_INVESTIGATOR
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