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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03404830
Other study ID # University of Jaén
Secondary ID
Status Completed
Phase N/A
First received December 5, 2017
Last updated April 22, 2018
Start date September 1, 2017
Est. completion date December 1, 2017

Study information

Verified date January 2018
Source University of Jaén
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 1, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain AQUASPORT PIZARRA pool Pizarra Málaga

Sponsors (1)

Lead Sponsor Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opto-electric measuring system. To be used to control the parameters of the gait. Up to twelve weeks.
Primary CT10P 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.
Primary UPDATE AND PERFORM THE TEST 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. Up to twelve weeks.
Primary Sensor Medica 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.
Primary Opto-electric measurement system 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.
Primary Dynamometer Be used to assess the muscle strength of each participant in your dominant hand. Up to twelve weeks.
Primary Confidence Scale of the specific balance of activities (ABC) Be used to assess the fear of falling. Up to twelve weeks.
Primary Falls Efficacy Scale-International (FES-I) Be used to assess the confidence in carrying out daily activities of the participants. Up to twelve weeks.
Primary Pulsometer It will be used to measure the heart rate of the participants in the performance of a cardiorespiratory function test. Up to twelve weeks.
Primary UKK walk test of 2 km 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.
Primary InBody 720 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.
Primary SF-36 (The Short Form-36 Health Survey) Will be used to assess the quality of life in its Spanish version. Up to twelve weeks.
Primary HADS (Hospital Anxiety And Depression Scale) It will be used to evaluate the depression and anxiety levels of the participants. Up to twelve weeks.
Primary Accelerometer 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.