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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03919968
Other study ID # 91923318.7.0000.5402
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date November 13, 2023

Study information

Verified date November 2023
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 13, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 89 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Brazil Bruna T C Saraiva Presidente Prudente Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Autonomic Cardiac Modulation The heart rate variability will be collected by means of the POLAR V800. Change from Baseline Autonomic Cardiac Modulation to 3 months after intervention
Secondary Physical activity level - objective measure Will be collected 7 days of accelerometry by ActiGraph's triaxial accelerometer wGT3X-BT giving the measure in counts per minute. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Self-reported physical activity level questionnaire 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 Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Self-reported sedentary behaviour questionnaire 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). Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Quality of life questionnaire 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. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Force- objective measure 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. Pre baseline, Post 3 months (Pre-intervention), Post-intervention 6 months
Secondary Flexibility- objective measure 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. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Agility and dynamic balance - objective measure 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. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Cardiorespiratory capacity- 6-minute walk test 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. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Bone Mineral Density The bone mineral density will be evaluated through dual energy x-ray absorptiometry. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Body fat The body fat will be evaluated using the octopolar apparatus InBody 720 (Copyright®, 1996-2006, by Biospace Corporation, USA) in percentage. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Fat mass The fat mass will be evaluated using the octopolar apparatus InBody 720 (Copyright®, 1996-2006, by Biospace Corporation, USA) in kilograms. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Muscle mass The muscle mass will be evaluated using the octopolar apparatus InBody 720 (Copyright®, 1996-2006, by Biospace Corporation, USA) in kilograms. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Cognitive ability 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. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Systolic Blood pressure The systolic blood pressure will be measured by means of the omron digital oscillometric device. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Diastolic Blood pressure The diastolic blood pressure will be measured by means of the omron digital oscillometric device. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Resting heart rate The resting heart rate will be measured by means of the omron digital oscillometric device. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Blood flow of the arteries To verify the blood flow of the carotid and femoral arteries will be used the ultrasound doopler Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Thickness of the arteries To verify the thickness of the carotid and femoral arteries will be used the ultrasound doopler Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Flow-mediated dilation Flow-mediated dilation will be assessed by pre and post occlusion doopler ultrasound of the brachial artery. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
Secondary Anxiety and depression questionnaire 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. Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
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