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High Intensity Training to Reduce the Risk of Falls in Older People

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ClinicalTrials.gov Identifier: NCT03404830
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Agustín Aibar Almazán, University of Jaén

Study Description
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Brief Summary:
Due to the high incidence of falls in the elderly population, this study is presented as a method to reduce the risk of falls through a specific type of training in people over 60 years of age.

Condition or disease Intervention/treatment Phase
Risk of Falls Other: HIIT group, MICT group Not Applicable

Detailed Description:
A 16-week high intensity interval training (HIIT) program, compared to a continuous exercise program and one that does not perform any training program, decreases the risk of falls and improves the state of health, physical condition and quality of life to a greater extent than a group that does not perform any type of exercise in people over 60 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Groups were assigned during the months of July and August through the sports centers where these elderly people performed some kind of physical activity.
Primary Purpose: Treatment
Official Title: Effects of a Program of High Intensity Exercise by Intervals on the Risk of Falls the Physical Condition and the State of Health in People Over 60 Years
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arms and Interventions
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Arm Intervention/treatment
Experimental: HIIT group
This group receives physical training based on HIIT
 Other: HIIT group, MICT group

The HIIT program training:

5 minutes of heating will be done. The intervention will consist of a training in suspension (TRX) performing squats. The session will be divided into four four-minute intervals at an intensity of 90-95% of the maximum heart rate, followed by three-minute active rest intervals of 50-70%. This intensity will be assigned to each subject individually. After the training, there will be a return to calm of 10 minutes of exercises of joint range. There will be 2 weekly training, with three days between both training, for a period of 12 weeks.

The training of the MICT program:

5 minutes of heating will be done. Subsequently, participants will perform a squat training with the Suspension Training System (TRX) with an intensity close to 70% of their maximum heart rate maintained for 40 minutes. The session will conclude with a return to calm of 10 min of joint width and stretching.
Experimental: MICT group
This group receives physical training based on MICT
 Other: HIIT group, MICT group

The HIIT program training:

5 minutes of heating will be done. The intervention will consist of a training in suspension (TRX) performing squats. The session will be divided into four four-minute intervals at an intensity of 90-95% of the maximum heart rate, followed by three-minute active rest intervals of 50-70%. This intensity will be assigned to each subject individually. After the training, there will be a return to calm of 10 minutes of exercises of joint range. There will be 2 weekly training, with three days between both training, for a period of 12 weeks.

The training of the MICT program:

5 minutes of heating will be done. Subsequently, participants will perform a squat training with the Suspension Training System (TRX) with an intensity close to 70% of their maximum heart rate maintained for 40 minutes. The session will conclude with a return to calm of 10 min of joint width and stretching.
No Intervention: No intervention group
This group does not receive any treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Opto-electric measuring system. [ Time Frame: Up to twelve weeks. ]
    To be used to control the parameters of the gait.

  2. CT10P [ Time Frame: Up to twelve weeks. ]
    Can be used for the assessment of dynamic equilibrium, which aims to walk ten steps followed by a straight line on the ground, in the shortest time possible, without losing speed, or support a cake off the line.

  3. UPDATE AND PERFORM THE TEST [ Time Frame: Up to twelve weeks. ]
    Be employed for the assessment of dynamic balance, in which the subject starts from the sitting position in a chair (without palm rest). The evaluator's verbal signal initiates time control (sec). The evaluator must: get up from the chair, travel a distance of 3 meters, go around a pivot, travel the same distance back and sit back in the chair as quickly as possible. The closing of the time is established when the evaluated subject makes contact with the chair sitting down.

  4. Sensor Medica [ Time Frame: Up to twelve weeks. ]
    It has been used to measure the static equilibrium and the calculation of the displacement of the center of pressures (CoP).

  5. Opto-electric measurement system [ Time Frame: Up to twelve weeks. ]
    It has been used for the evaluation of the reaction speed of the lower train and the upper train of the participants, with three different tests, acoustic, optical and optoacoustic.

  6. Dynamometer [ Time Frame: Up to twelve weeks. ]
    Be used to assess the muscle strength of each participant in your dominant hand.

  7. Confidence Scale of the specific balance of activities (ABC) [ Time Frame: Up to twelve weeks. ]
    Be used to assess the fear of falling.

  8. Falls Efficacy Scale-International (FES-I) [ Time Frame: Up to twelve weeks. ]
    Be used to assess the confidence in carrying out daily activities of the participants.

  9. Pulsometer [ Time Frame: Up to twelve weeks. ]
    It will be used to measure the heart rate of the participants in the performance of a cardiorespiratory function test.

  10. UKK walk test of 2 km [ Time Frame: Up to twelve weeks. ]
    It will be necessary to assess the cardiorespiratory frequency of the participants in a walking test 2 km as fast as possible.

  11. InBody 720 [ Time Frame: Up to twelve weeks. ]
    It will be used for the assessment of the lean muscle mass, the segmental fat mass and the amount of intra and extracellular water.

  12. SF-36 (The Short Form-36 Health Survey) [ Time Frame: Up to twelve weeks. ]
    Will be used to assess the quality of life in its Spanish version.

  13. HADS (Hospital Anxiety And Depression Scale) [ Time Frame: Up to twelve weeks. ]
    It will be used to evaluate the depression and anxiety levels of the participants.

  14. Accelerometer [ Time Frame: Up to twelve weeks. ]
    It will be used to assess the quality of sleep, control of the period of physical activity, sedentary period and energy expenditure.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To participate in the study, participants will be required to be 60 years of age or older.

Exclusion Criteria:

  • All participants with diseases that may alter balance and functional activity (such as auditory or vestibular alterations), central or peripheral neurological disorders, other rheumatological diseases, or serious psychiatric or somatic diseases will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404830


Locations
Spain
AQUASPORT PIZARRA pool
Pizarra, Málaga, Spain, 29560
Sponsors and Collaborators
University of Jaén
More Information
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Responsible Party: Agustín Aibar Almazán, Principal Investigator, University of Jaén
ClinicalTrials.gov Identifier: NCT03404830     History of Changes
Other Study ID Numbers: University of Jaén
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No