Quality of LifeNCT04638322
Effects of Functional Training by High Intensity Intervals in Older Adults With Mild Cognitive Impairment.
A study testing HIFT Group in people with Quality of Life and Aging, run by University of Jaén at 1 site in Colombia.
Trial summary
To analyze the effects of a high intensity interval functional training program (HIFT), in the cognitive and functional capacities of Colombian older adults with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Quality of Life, Aging
- What is being tested?
- HIFT Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2021to 1 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 60 years
- Adults with mild cognitive impairment
- Not participating in any physical exercise program
- Sufficient physical autonomy to participate in the physical activities required by the study
- Have no signs of dementia (<26 on MoCA)
- Be able to understand instructions, programs and protocols.
Who cannot join
- Contraindications for conducting physical tests
- Diseases that limit cognitive performance and physical activity.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Casa de los Tiempos
Cali, Valle del Cauca Department, 760031
About this study
Official title: Effects of a High Intensity Interval Functional Training Program on the Cognitive and Functional Capabilities of Older Adults With Mild Cognitive Impairment.
To analyze the effects of a high intensity interval functional training program (HIFT), in the cognitive and functional capacities of Colombian older adults with mild cognitive impairment.
Read the detailed description
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
An experimental group (GE) that after an initial evaluation will undergo a physical training program based on high intensity interval functional training exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
- Conditions
- Quality of Life, Aging
- Being tested
- HIFT Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFT GroupOther
An experimental group (EG) that after an initial evaluation will be subjected to a physical training program based on the HIFT method, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 min per session. Once the intervention is finished, you will undergo a final evaluation to see if there is a difference or not with the results obtained at the beginning.
| Study group | Role | What they receive |
|---|---|---|
| HIFT Group | Experimental | This group receives physical training based on exercises of high intensity interval functional training. Receives: Other: HIFT 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.
MoCA (Montreal Cognitive Assessment)
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
Measured: Up to twelve weeks.
TMT (Trail Making Test)
It is used to assess executive function. It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters. Longer completion times indicate poor performance.
Measured: Up to twelve weeks.
Isaacs test
Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.
Measured: Up to twelve weeks.
SFT (Senior Fitness Test)
Instrument used to assess functional abilities. It consists of the following tests: muscle strength (upper and lower limbs), aerobic endurance, flexibility (upper and lower limbs) and agility, 6-minute walk test, Sit-to-foot test using a chair (measures flexibility of the lower body, Try to clasp hands behind your back, Try to get up, walk 8 feet and sit back.
Measured: Up to twelve weeks.
The Lawton & Brody scale
Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence.
In a conventional way, the following classification can be assumed:
Grades A-B or 0 - 1 points = absence of disability or mild disability. Grades C-D or 2 - 3 points = moderate disability. Grades E-G or 4 - 6 points = severe disability.
Measured: Up to twelve weeks
The Short Form-36 Health Survey (SF-36)
Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.
Measured: Up to twelve weeks
The Yesavage Geriatric Depression Scale
Questionnaire used to screen for depression in older people. Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.
Measured: Up to twelve weeks
Mini-Mental State Examination (MMSE)
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
Measured: Up to twelve weeks
PSQI (Pittsburgh Sleep Quality Index)
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.
Measured: Up to twelve weeks
Tinetti scale
It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
Measured: Up to twelve weeks
Frailty phenotype
Five original characteristics are evaluated: involuntary weight loss, self-reported exhaustion, slow gait speed, weakness, and low physical activity.
Measured: Up to twelve weeks
The 8 foot up & go test
Assesses agility and dynamic balance.
Measured: Up to twelve weeks
KATZ INDEX
Is a widely used tool to assess the level of independency in older adults. It is scored considering the items grouped to obtain degrees A, B, C, etc., of independence. It is observed that 0 points are equal to grade A, 1 point to grade B, 2 points to grade C, 3 points to grade D, and so on.
In a conventional way, the following classification can be assumed:
Grades A-B or 0 - 1 points = absence of disability or mild disability. Grades C-D or 2 - 3 points = moderate disability. Grades E-G or 4 - 6 points = severe disability.
Measured: Up to twelve weeks
Chair sit and reach test
To test low back and hamstring flexibility.
Measured: Up to twelve weeks
Back scratch test
To measure general shoulder range of motion.
Measured: Up to twelve weeks
Secondary outcomes (7)
D2 test
Time-limited test to measure concentration. The test measures the processing speed, the following of instructions and the goodness of the execution in a task of discrimination of similar visual stimuli and that, therefore, allow the estimation of attention and concentration.
Measured: Up to twelve weeks.
DSST (The Digit Symbol Substitution Test)
Cognitive test to assess processing speed presented on a single sheet of paper that requires a subject to match symbols with numbers according to a key located at the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90-120 seconds, constitutes the score.
Measured: Up to twelve weeks.
Mindful Attention Awareness Scale (MAAS)
It evaluates, in a global way, the dispositional capacity of an individual to be attentive and aware of the experience of the present moment in everyday life. The scale is a 15-item univariate self-report with a view of the mindfulness construct centered on the attention / consciousness variable.
Measured: Up to twelve weeks.
Handgrip Strength
Dynamometer will be employed to assess hand grip stregth.
Measured: Up to twelve weeks.
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat
Measured: Up to twelve weeks.
Waist circumference
Is used to assess central fat distribution and degree of abdominal obesity
Measured: Up to twelve weeks.
Waist-to-hip ratio
Is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement
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 posted20 Nov 2020
- Study start1 Feb 2021
- Primary completion23 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- 52 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
- NCT04638322
- Sponsor's protocol ID
- University of Jaén (2020)
- Status last verified
- Feb 2023
- First submitted
- 27 Oct 2020
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High Intensity Interval Functional Training Program on the Cognitive and Functional Capabilities of Older Adults With Mild Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT04638322
- Acronym / sponsor ID
- University of Jaén (2020)
- Conditions
- Quality of Life, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 20 Nov 2020 (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.
To analyze the effects of a high intensity interval functional training program (HIFT), in the cognitive and functional capacities of Colombian older adults with mild cognitive impairment.
Detailed description
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
An experimental group (GE) that after an initial evaluation will undergo a physical training program based on high intensity interval functional training exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| HIFT Group | Experimental | Other: HIFT GroupThis group receives physical training based on exercises of high intensity interval functional training. |
| No intervention group | No intervention | –This group does not receive any treatment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- More than 60 years
- Adults with mild cognitive impairment
- Not participating in any physical exercise program
- Sufficient physical autonomy to participate in the physical activities required by the study
- Have no signs of dementia (<26 on MoCA)
Key exclusion criteria (2 listed)
- Contraindications for conducting physical tests
- Diseases that limit cognitive performance and physical activity.
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 |
|---|---|---|
| HIFT GroupAn experimental group (EG) that after an initial evaluation will be subjected to a physical training program based on the HIFT method, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 min per session. Once the intervention is finished, you will undergo a final evaluation to see if there is a difference or not with the results obtained at the beginning. | Other | HIFT Group |
Primary outcome
MoCA (Montreal Cognitive Assessment)
Time frame: Up to twelve weeks.
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
TMT (Trail Making Test)
Time frame: Up to twelve weeks.
It is used to assess executive function. It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters. Longer completion times indicate poor performance.
Isaacs test
Time frame: Up to twelve weeks.
Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.
SFT (Senior Fitness Test)
Time frame: Up to twelve weeks.
Instrument used to assess functional abilities. It consists of the following tests: muscle strength (upper and lower limbs), aerobic endurance, flexibility (upper and lower limbs) and agility, 6-minute walk test, Sit-to-foot test using a chair (measures flexibility of the lower body, Try to clasp hands behind your back, Try to get up, walk 8 feet and sit back.
The Lawton & Brody scale
Time frame: Up to twelve weeks
Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence. In a conventional way, the following classification can be assumed: Grades A-B or 0 - 1 points = absence of disability or mild disability. Grades C-D or 2 - 3 points = moderate disability. Grades E-G or 4 - 6 points = severe disability.
The Short Form-36 Health Survey (SF-36)
Time frame: Up to twelve weeks
Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.
The Yesavage Geriatric Depression Scale
Time frame: Up to twelve weeks
Questionnaire used to screen for depression in older people. Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.
Mini-Mental State Examination (MMSE)
Time frame: Up to twelve weeks
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
PSQI (Pittsburgh Sleep Quality Index)
Time frame: Up to twelve weeks
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.
Tinetti scale
Time frame: Up to twelve weeks
It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
Frailty phenotype
Time frame: Up to twelve weeks
Five original characteristics are evaluated: involuntary weight loss, self-reported exhaustion, slow gait speed, weakness, and low physical activity.
The 8 foot up & go test
Time frame: Up to twelve weeks
Assesses agility and dynamic balance.
KATZ INDEX
Time frame: Up to twelve weeks
Is a widely used tool to assess the level of independency in older adults. It is scored considering the items grouped to obtain degrees A, B, C, etc., of independence. It is observed that 0 points are equal to grade A, 1 point to grade B, 2 points to grade C, 3 points to grade D, and so on. In a conventional way, the following classification can be assumed: Grades A-B or 0 - 1 points = absence of disability or mild disability. Grades C-D or 2 - 3 points = moderate disability. Grades E-G or 4 - 6 points = severe disability.
Chair sit and reach test
Time frame: Up to twelve weeks
To test low back and hamstring flexibility.
Back scratch test
Time frame: Up to twelve weeks
To measure general shoulder range of motion.
7 secondary outcomes
D2 test
Time frame: Up to twelve weeks.
DSST (The Digit Symbol Substitution Test)
Time frame: Up to twelve weeks.
Mindful Attention Awareness Scale (MAAS)
Time frame: Up to twelve weeks.
Handgrip Strength
Time frame: Up to twelve weeks.
BMI (Body Mass Index)
Time frame: Up to twelve weeks.
Waist circumference
Time frame: Up to twelve weeks.
Waist-to-hip ratio
Time frame: Up to twelve weeks.
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 17 Feb 2023.
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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 HIFT Group in people with Quality of Life and Aging, run by University of Jaén at 1 site in Colombia.
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 6 inclusion and 2 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 17 Feb 2023. 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 Colombia. 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?
MoCA (Montreal Cognitive Assessment) (time frame: Up to twelve weeks.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023.