Risk of FallsNCT03404830
High Intensity Training to Reduce the Risk of Falls in Older People
A study testing HIIT group, MICT group in people with Risk of Falls, run by University of Jaén at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Risk of Falls
- What is being tested?
- HIIT group, MICT group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate in the study, participants will be required to be 60 years of age or older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Risk of Falls
- Being tested
- HIIT group, MICT group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT group, MICT groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HIIT group | Experimental | This group receives physical training based on HIIT Receives: Other: HIIT group, MICT group |
| MICT group | Experimental | This group receives physical training based on MICT Receives: Other: HIIT group, MICT group |
| No intervention group | No intervention | This group does not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opto-electric measuring system.
To be used to control the parameters of the gait.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to twelve weeks.
Dynamometer
Be used to assess the muscle strength of each participant in your dominant hand.
Measured: Up to twelve weeks.
Confidence Scale of the specific balance of activities (ABC)
Be used to assess the fear of falling.
Measured: Up to twelve weeks.
Falls Efficacy Scale-International (FES-I)
Be used to assess the confidence in carrying out daily activities of the participants.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to twelve weeks.
HADS (Hospital Anxiety And Depression Scale)
It will be used to evaluate the depression and anxiety levels of the participants.
Measured: 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.
Measured: Up to twelve weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Sep 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk of FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404830
- Sponsor's protocol ID
- University of Jaén
- Status last verified
- Jan 2018
- First submitted
- 5 Dec 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33572909
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03404830
- Acronym / sponsor ID
- University of Jaén
- Conditions
- Risk of Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Experimental | Other: HIIT group, MICT groupThis group receives physical training based on HIIT |
| MICT group | Experimental | Other: HIIT group, MICT groupThis group receives physical training based on MICT |
| No intervention group | No intervention | –This group does not receive any treatment. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To participate in the study, participants will be required to be 60 years of age or older.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT group, MICT groupThe 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. | Other | HIIT group, MICT group |
Primary outcome
Opto-electric measuring system.
Time frame: Up to twelve weeks.
To be used to control the parameters of the gait.
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.
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.
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).
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.
Dynamometer
Time frame: Up to twelve weeks.
Be used to assess the muscle strength of each participant in your dominant hand.
Confidence Scale of the specific balance of activities (ABC)
Time frame: Up to twelve weeks.
Be used to assess the fear of falling.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 33572909Jimenez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT group, MICT group in people with Risk of Falls, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opto-electric measuring system. (time frame: Up to twelve weeks.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.