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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Effect of Muay Thai vs. Functional Training on the Cardiovascular Health of Elderly

Clinicaltrials.gov identifier NCT03919968

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted September 17, 2020

Study Description

Brief summary:

The elderly will be recruited, after meeting the inclusion criteria, will be submitted to data collection, all necessary assessments for the study and after 12 weeks, the same data will be collected, so that the elderly are self-control. After the second collection, the elderly will be randomized into two groups: the Muay Thai group and the functional training group. Both groups will train three times a week for 60 min and for 12 weeks. The training will be divided into 20 min of general exercises, 20 min of specific exercises and 20 min of fight simulation and/or play activities. At the end of the 12 weeks of intervention, evaluations and data collection will be performed again.

  • Condition or Disease:Elderly
  • Intervention/Treatment: Behavioral: Martial Arts
    Behavioral: Functional Training
  • Phase: N/A
Detailed Description

Will be recruited through media resources at least 50 elderly people aged between 60 and 89 years. Inclusion Criteria: Being literate; Age between 60 and 89 years; Ability to perform moderate-intensity exercises determined by the American College Sports Medicine (ACSM) assessment questionnaire; Medical certificate stating that the elderly are able to exercise; Sign the informed consent form. Exclusion Criteria: Perform any other systematic practice of physical exercise, in addition to regular physical activity, such as walking; Present serious cardiovascular pathologies; Present serious neurological pathologies; Present use of crutches, walking sticks, walkers, wheelchairs or other similar utensils; Present self-report of locomotion difficulties to carry out the intervention practice. These will have three moments of evaluations. Baseline, pre intervention (3 months) and post intervention (6 months) since the elderly will be controls themselves. They will perform anthropometric measurements, answer physical activity questionnaires, sedentary behavior, sleep quality, anxiety and depression, quality of life, cognition evaluation, body composition measurements, functional capacity, autonomic cardiac modulation, hemodynamics, flow and thickness of arteries, as well as flow-mediated dilatation. After the second-step measures (pre intervention 3 months), they will be randomized into two groups: Muay Thai and functional training. The functional training will be performed 3 times a week, for 12 weeks, during 60 minutes, being that will be divided into 20 min of general exercises, 20 min of specific exercises and 20 min of play activities. The activities will be carried out in a way adapted for the elderly. Will be carried out neuromotor control / coordination, balance, flexibility and static and dynamic stabilization. They will also have acceleration and deceleration activities, rotation and counter-rotation, extension and counter-extension, flexion and counter-flexion. The Muay Thai training will be performed 3 times a week, for 12 weeks, during 60 minutes, being that will be divided into 20 min of general exercises, 20 min of specific exercises (punches, kicks, knees, elbows, defenses and dodges) and 20 min of fight simulation and / or play activities. The activities will be carried out in a way adapted for the elderly. Will be used kickers, gauntlets, thorax and head protectors, shin guards, gloves, and other devices.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 36 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Effect of Muay Thai vs. Functional Training on the Health of Elderly: A Randomized Clinical Trial
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Active Comparator: Functional Training
The training will be performed 3 times a week, for 12 weeks, during 60 minutes, being that will be divided into 20 min of general exercises, 20 min of specific exercises and 20 min of play activities. The activities will be carried out in a way adapted for the elderly. Will be carried out neuromotor control / coordination, balance, flexibility and static and dynamic stabilization. They will also have acceleration and deceleration activities, rotation and counter-rotation, extension and counter-extension, flexion and counter-flexion.
Behavioral: Martial Arts
The training will be performed 3 times a week, for 12 weeks, during 60 minutes, being that will be divided into 20 min of general exercises, 20 min of specific exercises and 20 min of fight simulation and / or play activities. The activities will be carried out in a way adapted for the elderly. Will be used kickers, gauntlets, thorax and head protectors, shin guards, gloves, and other devices.
Experimental: Martial Arts
The training will be performed 3 times a week, for 12 weeks, during 60 minutes, being that will be divided into 20 min of general exercises, 20 min of specific exercises and 20 min of fight simulation and / or play activities. The activities will be carried out in a way adapted for the elderly. Will be used kickers, gauntlets, thorax and head protectors, shin guards, gloves, and other devices.
Behavioral: Functional Training
The training will be performed 3 times a week, for 12 weeks, during 60 minutes, being that will be divided into 20 min of general exercises, 20 min of specific exercises and 20 min of play activities. The activities will be carried out in a way adapted for the elderly. Will be carried out neuromotor control / coordination, balance, flexibility and static and dynamic stabilization. They will also have acceleration and deceleration activities, rotation and counter-rotation, extension and counter-extension, flexion and counter-flexion.
Outcome Measures
  • Primary Outcome Measures: 1. Autonomic Cardiac Modulation [ Time Frame: Change from Baseline Autonomic Cardiac Modulation to 3 months after intervention ]
    The heart rate variability will be collected by means of the POLAR V800.
  • Secondary Outcome Measures: 1. Force- objective measure [ Time Frame: Pre baseline, Post 3 months (Pre-intervention), Post-intervention 6 months ]
    Will be performed the American Alliance for Health, Physical Education, Recreation and Dance (AAHPERD) battery tests. Will use a 2-kg halter to measure upper limb strength, make as many elbow push-ups with the halter on hand in 30 seconds the final test result is the best performance of two trials performed. Below 7 repetitions is considered weak strength, above is good.
  • 2. Physical activity level - objective measure [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    Will be collected 7 days of accelerometry by ActiGraph's triaxial accelerometer wGT3X-BT giving the measure in counts per minute.
  • 3. Self-reported physical activity level questionnaire [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The modified Baecke's questionnaire for the elderly will be used to evaluate the practice of physical activity and a score will be calculated, both for total practice and for domains, the quartile of the evaluated elderly will be calculated and below 25 will be considered insufficiently active, above with sufficient physical activity practice
  • 4. Self-reported sedentary behaviour questionnaire [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The participants were asked to state the total time they usually spent (expressed in minutes per day) sitting or reclining including at work, at home, getting to and from places, or with friends (e.g. sitting at a desk, sitting with friends, travelling in car, bus, train, reading, playing cards or watching television).
  • 5. Quality of life questionnaire [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The questionnaire validated for the elderly will be applied the Short Form Health Survey (SF-36), composed of 36 questions with a score ranging from 0 to 100, being 0 the worst and 100 best.
  • 6. Flexibility- objective measure [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    Will be performed the American Alliance for Health, Physical Education, Recreation and Dance (AAHPERD) battery tests. Will be by means of sitting and reaching adapted. Below 47 cm is considered weak flexibility, above is good.
  • 7. Agility and dynamic balance - objective measure [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    Will be performed the American Alliance for Health, Physical Education, Recreation and Dance (AAHPERD) battery tests. It will be evaluated sitting in a chair with two cones positioned one on the right side and another on the left the goal is to turn the cones and sit and time will be timed. Two attempts are made and the shortest time is counted in seconds as the final result.
  • 8. Cardiorespiratory capacity- 6-minute walk test [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The teste will be performed in a 30-meter corridor, and the subjects were instructed to keep walking for 6 minutes. The best way will be considered for analysis. Below 400-meter is considered with low cardiorespiratory capacity, above is good.
  • 9. Bone Mineral Density [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The bone mineral density will be evaluated through dual energy x-ray absorptiometry.
  • 10. Body fat [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The body fat will be evaluated using the octopolar apparatus InBody 720 (Copyright®, 1996-2006, by Biospace Corporation, USA) in percentage.
  • 11. Fat mass [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The fat mass will be evaluated using the octopolar apparatus InBody 720 (Copyright®, 1996-2006, by Biospace Corporation, USA) in kilograms.
  • 12. Muscle mass [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The muscle mass will be evaluated using the octopolar apparatus InBody 720 (Copyright®, 1996-2006, by Biospace Corporation, USA) in kilograms.
  • 13. Cognitive ability [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The cognitive capacity of the elderly will be evaluated by the Mini-mental state exam. Consists of two parts, one that includes guidance, memory and attention, with a maximum score of 21 points, and another that addresses specific skills such as naming and comprehension, with a maximum score of 9 points, totaling a score of 30 points. Higher scores indicate greater cognitive performance.
  • 14. Systolic Blood pressure [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The systolic blood pressure will be measured by means of the omron digital oscillometric device.
  • 15. Diastolic Blood pressure [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The diastolic blood pressure will be measured by means of the omron digital oscillometric device.
  • 16. Resting heart rate [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    The resting heart rate will be measured by means of the omron digital oscillometric device.
  • 17. Blood flow of the arteries [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    To verify the blood flow of the carotid and femoral arteries will be used the ultrasound doopler
  • 18. Thickness of the arteries [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    To verify the thickness of the carotid and femoral arteries will be used the ultrasound doopler
  • 19. Flow-mediated dilation [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    Flow-mediated dilation will be assessed by pre and post occlusion doopler ultrasound of the brachial artery.
  • 20. Anxiety and depression questionnaire [ Time Frame: Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention) ]
    Will be assessed by hospital anxiety and depression scale aims to detect mild degrees of affective disorders in non-psychiatric settings. It consists of 14 multiple choice items, seven of which are for anxiety assessment and seven for depression. Each item can be punctuated from 0 to 3, reaching a maximum of 21 points in each subscale. An indicative score of anxiety equal to or greater than 8; and a score indicative of depression equal to or greater than 9.
Eligibility Criteria
  • Ages Eligible for Study: 60 to 89 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Being literate;

- Age between 60 and 89 years;

- Ability to perform moderate-intensity exercises determined by the American College
Sports Medicine (ACSM) assessment questionnaire;

- Medical certificate stating that the elderly are able to exercise;

- Sign the informed consent form.

Exclusion Criteria:

- Perform any other systematic practice of physical exercise, in addition to regular
physical activity, such as walking;

- Present serious cardiovascular pathologies;

- Present serious neurological pathologies;

- Present use of crutches, walking sticks, walkers, wheelchairs or other similar
utensils;

- Present self-report of locomotion difficulties to carry out the intervention practice.

Contacts and Locations
Contacts

Contact: Bruna Saraiva +5518997196380 brunatcsaraiva@gmail.com

Locations

Brazil, Sao Paulo
Bruna T C Saraiva
Presidente Prudente

Sponsors and Collaborators

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

Principal Investigator: Diego Christofaro, PhD Universidade Estadual Paulista - UNESP

More Information
  • Responsible Party: Universidade Estadual Paulista Júlio de Mesquita Filho
  • ClinicalTrials.gov Identifier: NCT03919968 History of Changes
  • Other Study ID Numbers: 91923318.7.0000.5402
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: September 17, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Universidade Estadual Paulista Júlio de Mesquita Filho: Elderly
    Martial Arts
    Functional Training
    Cardiovascular
    Health