- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03919968
Effect of Muay Thai vs. Circuit Training on the Cardiovascular Health of Elderly
Effect of Muay Thai vs. Circuit Training on the Health of Elderly: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sao Paulo
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Presidente Prudente, Sao Paulo, Brazil
- Bruna T C Saraiva
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Baseline Autonomic Cardiac Modulation to 3 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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).
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
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Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
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Pre baseline, Post 3 months (Pre-intervention), Post-intervention 6 months
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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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
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Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
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Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
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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.
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Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
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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.
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Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
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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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
|
Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
|
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.
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Pre baseline, Post 3 months (Pre-intervention) and Post 6 months (Post-intervention)
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Collaborators and Investigators
Investigators
- Principal Investigator: Diego Christofaro, PhD, Universidade Estadual Paulista - UNESP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 91923318.7.0000.5402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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