- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404830
High Intensity Training to Reduce the Risk of Falls in Older People
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Málaga
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Pizarra, Málaga, Spain, 29560
- AQUASPORT PIZARRA pool
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No intervention group
This group does not receive any treatment.
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|
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Experimental: HIIT group
This group receives physical training based on HIIT
|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opto-electric measuring system.
Time Frame: Up to twelve weeks.
|
To be used to control the parameters of the gait.
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
|
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.
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Up to twelve weeks.
|
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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).
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
|
Dynamometer
Time Frame: Up to twelve weeks.
|
Be used to assess the muscle strength of each participant in your dominant hand.
|
Up to twelve weeks.
|
|
Confidence Scale of the specific balance of activities (ABC)
Time Frame: Up to twelve weeks.
|
Be used to assess the fear of falling.
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
|
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.
|
Up to twelve weeks.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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
- University of Jaén
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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