NCT03404830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
Last Updated

April 24, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

December 5, 2017

Last Update Submit

April 22, 2018

Conditions

Outcome Measures

Primary Outcomes (14)

  • Opto-electric measuring system.

    To be used to control the parameters of the gait.

    Up to twelve weeks.

  • 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.

  • 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.

  • 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.

  • 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.

  • Dynamometer

    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)

    Be used to assess the fear of falling.

    Up to twelve weeks.

  • Falls Efficacy Scale-International (FES-I)

    Be used to assess the confidence in carrying out daily activities of the participants.

    Up to twelve weeks.

  • 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.

  • 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.

  • 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.

  • 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.

  • HADS (Hospital Anxiety And Depression Scale)

    It will be used to evaluate the depression and anxiety levels of the participants.

    Up to twelve weeks.

  • 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.

Study Arms (3)

HIIT group

EXPERIMENTAL

This group receives physical training based on HIIT

Other: HIIT group, MICT group

MICT group

EXPERIMENTAL

This group receives physical training based on MICT

Other: HIIT group, MICT group

No intervention group

NO INTERVENTION

This group does not receive any treatment.

Interventions

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.

HIIT groupMICT group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AQUASPORT PIZARRA pool

Pizarra, Málaga, 29560, Spain

Location

Related Publications (1)

  • Jimenez-Garcia JD, Hita-Contreras F, de la Torre-Cruz MJ, Aibar-Almazan A, Achalandabaso-Ochoa A, Fabrega-Cuadros R, Martinez-Amat A. Effects of HIIT and MIIT Suspension Training Programs on Sleep Quality and Fatigue in Older Adults: Randomized Controlled Clinical Trial. Int J Environ Res Public Health. 2021 Jan 29;18(3):1211. doi: 10.3390/ijerph18031211.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Groups were assigned during the months of July and August through the sports centers where these elderly people performed some kind of physical activity.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2017

First Posted

January 19, 2018

Study Start

September 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 24, 2018

Record last verified: 2018-01

Locations