Healthy People ProgramsTKD&AgingNCT05275140
Adapted Taekwondo on Health Status in Older Women
A study testing Physical activity in people with Healthy People Programs, run by Universidad Católica del Maule at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy People Programs
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChile
- Study dates
- 1 May 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy People Programs
- Being tested
- Physical activity
- Keywords
- Public health, Physical Activity, Older adults, Active aging, Combat sports.
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Also called Physical fitness
Combat sports and exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 (adapted taekwondo) | Experimental | 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. Receives: Other: Physical activity |
| Experimental group 2 (multi-component training) | Active comparator | 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. Receives: Other: Physical activity |
| Experimental group 3 (walking program) | Active comparator | 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. Receives: Other: Physical activity |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Blood Pressure at 16 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.
Measured: 2 weeks
Change from Lipid Profile at 16 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.
Measured: 2 weeks
Change from Frequency of Food Consumption at 16 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).
Measured: 2 weeks
Change from Anthropometric measurements at 16 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.
Measured: 2 weeks
Change from Body Composition (muscle mass) at 16 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.
Measured: 2 weeks
Change from Body Composition (fat mass) at 16 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.
Measured: 2 weeks
Change from Body Composition (fat mass) by bioimpedance at 16 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).
Measured: 2 weeks
Change from Body Composition (fat-free mass) by bioimpedance at 16 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).
Measured: 2 weeks
Change from Cognitive Status at 16 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).
Measured: 2 weeks
Change from Brain Activity at 16 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).
Measured: 2 weeks
Change from Quality of Life Perception at 16 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).
Measured: 2 weeks
Change from Physical-Functional Fitness (strenght of the lower body) at 16 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.
Measured: 2 weeks
Change from Physical-Functional Fitness (strenght on the upper body) at 16 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.
Measured: 2 weeks
Change from Physical-Functional Fitness (aerobic fitness) at 16 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.
Measured: 2 weeks
Change from Physical-Functional Fitness (flexibility of the lower-body) at 16 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.
Measured: 2 weeks
Change from Physical-Functional Fitness (flexibility on the upper-body) at 16 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.
Measured: 2 weeks
Change from Physical-Functional Fitness (agility and dynamic balance) at 16 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.
Measured: 2 weeks
Change from Handgrip Strength at 16 weeks
The handgrip strength will be measured with a hydraulic dynamometer (Camry, model EH101, China)
Measured: 2 weeks
Change from Postural Balance at 16 weeks
The postural balance will be obtained with a force platform (ArtOficio Ltda., Chile).
Measured: 2 weeks
Secondary outcomes (1)
Sociodemographic Assessments
Age (years), academic level (primary, secondary, bachelor, master, PhD), civil status (married, separated, widow, single, others).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 May 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Healthy People ProgramsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Valdés-Badilla, Universidad Católica del Maule
- Investigators
- Pablo Valdés-Badilla, PhD, Principal investigator, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275140
- Sponsor's protocol ID
- 11220035
- Acronym
- TKD&Aging
- Status last verified
- Mar 2024
- First submitted
- 14 Jan 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared. We will only disseminate the results of the study through scientific papers and presentations at scientific congresses
Publications
Yerrakalva D, Yerrakalva D, Hajna S, Griffin S. Effects of Mobile Health App Interventions on Sedentary Time, Physical Activity, and Fitness in Older Adults: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Nov 28;21(11):e14343. doi: 10.2196/14343.
PubMed 31778121Zubala A, MacGillivray S, Frost H, Kroll T, Skelton DA, Gavine A, Gray NM, Toma M, Morris J. Promotion of physical activity interventions for community dwelling older adults: A systematic review of reviews. PLoS One. 2017 Jul 10;12(7):e0180902. doi: 10.1371/journal.pone.0180902. eCollection 2017.
PubMed 28700754Grande GD, Oliveira CB, Morelhao PK, Sherrington C, Tiedemann A, Pinto RZ, Franco MR. Interventions Promoting Physical Activity Among Older Adults: A Systematic Review and Meta-Analysis. Gerontologist. 2020 Nov 23;60(8):583-599. doi: 10.1093/geront/gnz167.
PubMed 31868213Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
PubMed 31343601Chang YK, Pan CY, Chen FT, Tsai CL, Huang CC. Effect of resistance-exercise training on cognitive function in healthy older adults: a review. J Aging Phys Act. 2012 Oct;20(4):497-517. doi: 10.1123/japa.20.4.497. Epub 2011 Dec 20.
PubMed 22186664Valdes-Badilla PA, Gutierrez-Garcia C, Perez-Gutierrez M, Vargas-Vitoria R, Lopez-Fuenzalida A. Effects of Physical Activity Governmental Programs on Health Status in Independent Older Adults: A Systematic Review. J Aging Phys Act. 2019 Apr 1;27(2):265-275. doi: 10.1123/japa.2017-0396. Epub 2018 Nov 13.
PubMed 29989461McAuley PA, Artero EG, Sui X, Lee DC, Church TS, Lavie CJ, Myers JN, Espana-Romero V, Blair SN. The obesity paradox, cardiorespiratory fitness, and coronary heart disease. Mayo Clin Proc. 2012 May;87(5):443-51. doi: 10.1016/j.mayocp.2012.01.013. Epub 2012 Apr 12.
PubMed 22503065Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Reis RS, Salvo D, Ogilvie D, Lambert EV, Goenka S, Brownson RC; Lancet Physical Activity Series 2 Executive Committee. Scaling up physical activity interventions worldwide: stepping up to larger and smarter approaches to get people moving. Lancet. 2016 Sep 24;388(10051):1337-48. doi: 10.1016/S0140-6736(16)30728-0. Epub 2016 Jul 28.
PubMed 27475273Galloza J, Castillo B, Micheo W. Benefits of Exercise in the Older Population. Phys Med Rehabil Clin N Am. 2017 Nov;28(4):659-669. doi: 10.1016/j.pmr.2017.06.001.
PubMed 29031333Ramirez-Campillo R, Alvarez C, Garcia-Hermoso A, Celis-Morales C, Ramirez-Velez R, Gentil P, Izquierdo M. High-speed resistance training in elderly women: Effects of cluster training sets on functional performance and quality of life. Exp Gerontol. 2018 Sep;110:216-222. doi: 10.1016/j.exger.2018.06.014. Epub 2018 Jun 15.
PubMed 29909049Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.
PubMed 30419096Das Gupta S, Bobbert MF, Kistemaker DA. The Metabolic Cost of Walking in healthy young and older adults - A Systematic Review and Meta Analysis. Sci Rep. 2019 Jul 10;9(1):9956. doi: 10.1038/s41598-019-45602-4.
PubMed 31292471Fonseca Alves DJ, Bartholomeu-Neto J, Junior ER, Ribeiro Zarricueta BS, Nobrega OT, Cordova C. Walking Speed, Risk Factors, and Cardiovascular Events in Older Adults-Systematic Review. J Strength Cond Res. 2017 Nov;31(11):3235-3244. doi: 10.1519/JSC.0000000000002182.
PubMed 29065080
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05275140
- Acronym / sponsor ID
- TKD&Aging / 11220035
- Conditions
- Healthy People Programs
- Keywords
- Public health, Physical Activity, Older adults, Active aging, Combat sports.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 (adapted taekwondo) | Experimental | Other: Physical activityThe 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. |
| Experimental group 2 (multi-component training) | Active comparator | Other: Physical activityThe 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. |
| Experimental group 3 (walking program) | Active comparator | Other: Physical activityThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: Physical fitnessCombat sports and exercise | Other | Experimental group 1 (adapted taekwondo), Experimental group 2 (multi-component training), Experimental group 3 (walking program) |
Primary outcome
Change from Baseline Blood Pressure at 16 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 weeks
The handgrip strength will be measured with a hydraulic dynamometer (Camry, model EH101, China)
Change from Postural Balance at 16 weeks
Time frame: 2 weeks
The postural balance will be obtained with a force platform (ArtOficio Ltda., Chile).
1 secondary outcome
Sociodemographic Assessments
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 31778121Yerrakalva D, Yerrakalva D, Hajna S, Griffin S. Effects of Mobile Health App Interventions on Sedentary Time, Physical Activity, and Fitness in Older Adults: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Nov 28;21(11):e14343. doi: 10.2196/14343.
- Background: PubMed 28700754Zubala A, MacGillivray S, Frost H, Kroll T, Skelton DA, Gavine A, Gray NM, Toma M, Morris J. Promotion of physical activity interventions for community dwelling older adults: A systematic review of reviews. PLoS One. 2017 Jul 10;12(7):e0180902. doi: 10.1371/journal.pone.0180902. eCollection 2017.
- Background: PubMed 31868213Grande GD, Oliveira CB, Morelhao PK, Sherrington C, Tiedemann A, Pinto RZ, Franco MR. Interventions Promoting Physical Activity Among Older Adults: A Systematic Review and Meta-Analysis. Gerontologist. 2020 Nov 23;60(8):583-599. doi: 10.1093/geront/gnz167.
- Background: PubMed 31343601Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
- Background: PubMed 22186664Chang YK, Pan CY, Chen FT, Tsai CL, Huang CC. Effect of resistance-exercise training on cognitive function in healthy older adults: a review. J Aging Phys Act. 2012 Oct;20(4):497-517. doi: 10.1123/japa.20.4.497. Epub 2011 Dec 20.
- Background: PubMed 29989461Valdes-Badilla PA, Gutierrez-Garcia C, Perez-Gutierrez M, Vargas-Vitoria R, Lopez-Fuenzalida A. Effects of Physical Activity Governmental Programs on Health Status in Independent Older Adults: A Systematic Review. J Aging Phys Act. 2019 Apr 1;27(2):265-275. doi: 10.1123/japa.2017-0396. Epub 2018 Nov 13.
- Background: PubMed 22503065McAuley PA, Artero EG, Sui X, Lee DC, Church TS, Lavie CJ, Myers JN, Espana-Romero V, Blair SN. The obesity paradox, cardiorespiratory fitness, and coronary heart disease. Mayo Clin Proc. 2012 May;87(5):443-51. doi: 10.1016/j.mayocp.2012.01.013. Epub 2012 Apr 12.
- Background: PubMed 33239350Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Background: PubMed 21694556Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Background: PubMed 27475273Reis RS, Salvo D, Ogilvie D, Lambert EV, Goenka S, Brownson RC; Lancet Physical Activity Series 2 Executive Committee. Scaling up physical activity interventions worldwide: stepping up to larger and smarter approaches to get people moving. Lancet. 2016 Sep 24;388(10051):1337-48. doi: 10.1016/S0140-6736(16)30728-0. Epub 2016 Jul 28.
- Background: PubMed 29031333Galloza J, Castillo B, Micheo W. Benefits of Exercise in the Older Population. Phys Med Rehabil Clin N Am. 2017 Nov;28(4):659-669. doi: 10.1016/j.pmr.2017.06.001.
- Background: PubMed 29909049Ramirez-Campillo R, Alvarez C, Garcia-Hermoso A, Celis-Morales C, Ramirez-Velez R, Gentil P, Izquierdo M. High-speed resistance training in elderly women: Effects of cluster training sets on functional performance and quality of life. Exp Gerontol. 2018 Sep;110:216-222. doi: 10.1016/j.exger.2018.06.014. Epub 2018 Jun 15.
- Ministerio de Salud. Programa Más Adultos Mayores AutovalentesLink provided by the sponsor.
- Ministerio de Salud. Encuesta Nacional de Salud 2016-2017Link provided by the sponsor.
- Ministerio del Deporte. Encuesta Nacional de Hábitos de Actividad Física y Deporte 2018 en Población de 18 años y más.Link provided by the sponsor.
- Ministerio de Salud. Manual de Aplicación del Examen de Medicina Preventiva del Adulto MayorLink provided by the sponsor.
- International standards for anthropometric assessment. Wellington: ISAK, 2012.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Participant data will not be shared. We will only disseminate the results of the study through scientific papers and presentations at scientific congresses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Valdés-Badilla, PhD principal investigator
Universidad Católica del Maule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Healthy People Programs, run by Universidad Católica del Maule at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Blood Pressure at 16 weeks (time frame: 2 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275140, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.