Activities of Daily LivingNCT04221724

Effects of Function-focused Multicomponent Physical Exercise Program. Interventional Single Group Study

A study testing Multicomponent physical exercise program in people with Activities of Daily Living and Frailty, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research study is to determine whether a physical exercise program in nursing homes will maintain autonomy in activities of daily living, decrease vulnerability and improve physical, psychological and cognitive condition. Read more about this study

Who is it for?: Ages 70 to 115 yearsHealthy volunteers can take part
Conditions the study is for: Activities of Daily Living, Frailty, Older Adults
What is being tested?: Multicomponent physical exercise program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: 1 siteSpain
Study dates: 14 Jan 2019to 31 Dec 2020
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 70 to 115 years
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Aged ≥70years
Scored ≥50 on the Barthel index
Scored ≥20 on Mini Examen Cognoscitive test (MEC-35), validated and adapted Spanish version of Mini Mental State Examination
Be able to stand up from the chair and walk 10 meters with or without one person/technical assistance.

Who cannot join

If the participants are clinically unstable under the clinical judgment of the medical professionals of the reference center,
If the risk of adverse effects is greater than the benefit
If the participants have severe cognitive or psychiatric disorders.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Basque Country University
Leioa, Bizkaia, 48940

Other trials in Spain

About this study

Official title: A Multicomponent Physical Exercise Program: a Tool to Maintain Autonomy, Reduce Frailty and Improve Functionality in Nursing Homes. Interventional Single Group Study

Participant will engage in an exercise program for 6 months in their nursing homes, in two sessions per week of 45-60 minutes

Read the detailed description

Primary aim:

The major aim is to ascertain whether multicomponent exercise program focused on function can maintain autonomy in older adults living in nursing homes.

Secondary aims:

To ascertain the influence of the evaluated exercise program on frailty, physical, psycho-affective and cognitive conditions in older people living in nursing homes.
Analyze if the influence that the exercise program has had on dependence, frailty, physical, psycho-affective and cognitive condition is maintained after 6 months since the end of the program
Examine the influence that the exercise program has on different clinical outcomes: falls, hospitalizations, visits to emergency service, the level of dependence, etc.

Design: experimental, multi-center and single-group physical exercise intervention

Intervention:

Combined multicomponent physical exercise program that includes strength, balance and flexibility exercises and performed in long term care homes focused on functionality on activities of daily living.

The first 3 months the exercise program aims to restore the physical condition through the multicomponent exercise program. Feasibility and safety of the multicomponent exercise program were ascertained in a previous study (Arrieta et al., 2018; Rodriguez-Larrad et al., 2017). This program will comprise of upper and lower body strengthening exercises, using external weights for 2-3 sets of 8-12 repetitions at a progressive incremental intensity of 30-50% of 1Repetition Maximum (RM). In addition, static balance and flexibility exercise will be performed.

From 3th to 6th months, the objective will be to improve autonomy in daily live activities through the functional exercise program. Strength exercises will be maintained with external weights and the intensity will be increased to 60-70% of 1-RM, 2-3 sets of 8-12 repetitions. Attention tasks, temporal space dissociation and dynamic balance exercises will be added to increase the difficulty and intensity in balance exercises. Flexibility and fine handle will be also performed.

This intervention is individualized for each participant and is adjusted progressively during the 6 months. Weekly, two sessions of one hour are held and are supervised by physiotherapists or specialists in sports sciences trained specifically for the program. An interval of at least 48h between training sessions will be respected.

Conditions: Activities of Daily Living, Frailty, Older Adults, Long Term Care
Being tested: Multicomponent physical exercise program
Keywords: Exercise, Physical Activity, Aging
Medical subject headings: Frailty, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multicomponent physical exercise programOther
The intervention consists of a combined multicomponent exercise program (EP) carried out for 6 months that includes strength, balance, flexibility and functional exercises aimed to improve functioning on daily life activities. The EP will be divided into two parts:
The first 3 months the EP aims to restore the physical condition through the multicomponent exercise program. This program will comprise of upper and lower body strengthening exercises, using external weights for 2-3sets of 8-12repetitions at a progressive intensity of 30-50% of 1RM. In addition, static balance and flexibility exercise will be performed.
From 3th to 6th months, the objective will be to improve autonomy through the functional EP. Strength exercises intensity will be increased to 60-70% of 1-RM, 2-3sets of 8-12repetitions. Attention tasks, temporal space dissociation and dynamic balance exercises will be added to increase the intensity in balance exercises. Flexibility and fine handle will be also performed

Study groups in NCT04221724
Study group	Role	What they receive
Intervention Group	Experimental	Multicomponent physical exercise intervention Receives: Other: Multicomponent physical exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

Barthel Index
Autonomy on daily living activities will be analyzed using the Barthel index. The Barthel index is a questionnaire with 10 items that evaluates the autonomy of the participant in the activities of daily life and it will be evaluated with the reference caregiver in nursing home. The Barthel index evaluates the following items: Feeding, Bathing, Dressing, Grooming, Bowels, Bladder, Toilette use, Transfer, Walking and Stairs. This items are scored as follows: 0 points if it is totally dependent, 5 points if needs some help and 10 points if the participant is totally autonomous
Measured: Changes from baseline to 3rd 6th and 12th month
Short Physical Performance Battery
Short Physical Performance Battery (SPPB) evaluates balance, gait ability, and leg strength using a single tool. The score for each part is given in categorical modality (0-4). This set of tests serves to predict falls, weakness and mortality. The best score will be 12 points and total score less than 10 points indicates frailty and high risk of disability. 1 point of change in the total score has demonstrated to be of clinical relevance.
Measured: Changes from baseline to 3rd 6th and 12th month
Handgrip strength
To asses upper limbs strength (kg) will be used bilateral handgrip strength test by squeezing a dynamometer with maximum isometric effort for 5 seconds. It is a strong predictor of disability, morbidity, and mortality as well as one of the components of Fried's frailty phenotype. Ranges are corrected by BMI
Measured: Changes from baseline to 3rd 6th and 12th month
Timed Up and Go Test
Timed Up and Go (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The cut-off value for the TUG is 12 seconds The test score also correlates well with gait speed and the Barthel Index.
Measured: Changes from baseline to 3rd 6th and 12th month

Secondary outcomes (16)

Fried frailty index
Fried index uses 5 criteria to define frailty: weight loss, exhaustion, physical activity, walk time and grip strength. Fulfilling three of these criteria indicates clinical frailty.
Measured: Changes from baseline to 3rd 6th and 12th month
Tilburg frailty indicator
Tilburg indicator evaluates frailty through a self-reported questionnaire that includes physical, psychological and social domains. The score range is from 0 points to 15 points. High scores indicates higher frailty
Measured: Changes from baseline to 3rd 6th and 12th month
Rockwood frailty phenotype
9 phenotype ranging from very fit to terminally ill are evaluated in Rockwood frailty scale.
Measured: Changes from baseline to 3rd 6th and 12th month
Anthropometry-Weight
Weight (kg)
Measured: Changes from baseline to 3rd 6th and 12th month
Anthropometry-Height
Height (m)
Measured: Changes from baseline to 3rd 6th and 12th month
Body Mass Index
Body Mass Index (BMI), weight and height will be combined to report BMI in kg/m^2)
Measured: Changes from baseline to 3rd 6th and 12th month
Anthropometry-Circumferences
Neck circumference, mid arm circumference and calf circumference (cm)
Measured: Changes from baseline to 3rd 6th and 12th month
The Goldberg Anxiety and Depression Scale
The Goldberg Anxiety and Depression Scale will be used to assess affective state of anxiety and depression that includes nine depression and nine anxiety items from the last month. The cut-off points are ≥4 for the anxiety scale, and ≥2 for the depression scale.
Measured: Changes from baseline to 6th and 12th month
The Spanish Subjective Happiness scale
The Spanish Subjective Happiness scale test will be used to analyze the perceived happiness. It ranges from 0 to 28 points in four questions. Higher punctuation means higher happiness level.
Measured: Changes from baseline to 6th and 12th month
Quality of Life-Alzheimer Disease
Quality of Life-Alzheimer Disease (QoL-AD) test. Self-rated quality of life for people with cognitive impairments. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
Measured: Changes from baseline to 6th and 12th month
Montreal Cognitive Assessment test (MOCA test)
The cognitive function will be assessed by MOCA test. Montreal Cognitive Assessment cover domains: attention and concentration, executive functions, memory and language skills, conceptual thinking, calculation and orientation. The MOCA is a validated test in Spanish. It ranges from 0 ( worse score ) to 30 (best score). A score less than 26 indicates suggest mild cognitive decline
Measured: Changes from baseline to 6th and 12th month
Pain level
Using a score from 0 points (lowest) to 10 points (highest) the participant will be asked to say how much it hurts in different parts of the body such as shoulders, elbows, wrists, neck, back, hips, knees and ankles
Measured: Changes from baseline to 6th and 12th month
Clinical outcomes-Number of falls
Number of falls will be assessed with a clinical questionnaire
Measured: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
Clinical outcomes-visits to the emergency service
Visits to the emergency service will be assessed with a clinical questionnaire
Measured: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
Clinical outcomes-hospital admissions
Hospital admissions will be assessed with a clinical questionnaire
Measured: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
Clinical outcomes-functional impairment
Functional impairment after hospitalization will be assessed with a clinical questionnaire
Measured: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 201931 Dec 2020

First posted9 Jan 2020
Study start14 Jan 2019
Primary completion30 Jun 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Activities of Daily LivingStudies 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: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Multicenter single group interventional study
Masking: None (open label)
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04221724
Sponsor's protocol ID: Functional-Ageing On
Status last verified: Oct 2023
First submitted: 3 Jan 2020
Last updated: 27 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Rodriguez-Larrad A, Arrieta H, Rezola C, Kortajarena M, Yanguas JJ, Iturburu M, Susana MG, Irazusta J. Effectiveness of a multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: study protocol for a randomized clinical controlled trial. BMC Geriatr. 2017 Feb 23;17(1):60. doi: 10.1186/s12877-017-0453-0.
PubMed 28231827
Rezola-Pardo C, Rodriguez-Larrad A, Gomez-Diaz J, Lozano-Real G, Mugica-Errazquin I, Patino MJ, Bidaurrazaga-Letona I, Irazusta J, Gil SM. Comparison Between Multicomponent Exercise and Walking Interventions in Long-Term Nursing Homes: A Randomized Controlled Trial. Gerontologist. 2020 Sep 15;60(7):1364-1373. doi: 10.1093/geront/gnz177.
PubMed 31845733
Arrieta H, Rezola-Pardo C, Kortajarena M, Hervas G, Gil J, Yanguas JJ, Iturburu M, Gil SM, Irazusta J, Rodriguez-Larrad A. The impact of physical exercise on cognitive and affective functions and serum levels of brain-derived neurotrophic factor in nursing home residents: A randomized controlled trial. Maturitas. 2020 Jan;131:72-77. doi: 10.1016/j.maturitas.2019.10.014. Epub 2019 Nov 5.
PubMed 31787150
Rezola-Pardo C, Arrieta H, Gil SM, Zarrazquin I, Yanguas JJ, Lopez MA, Irazusta J, Rodriguez-Larrad A. Comparison between multicomponent and simultaneous dual-task exercise interventions in long-term nursing home residents: the Ageing-ONDUAL-TASK randomized controlled study. Age Ageing. 2019 Nov 1;48(6):817-823. doi: 10.1093/ageing/afz105.
PubMed 31595289
Arrieta H, Rezola-Pardo C, Gil SM, Virgala J, Iturburu M, Anton I, Gonzalez-Templado V, Irazusta J, Rodriguez-Larrad A. Effects of Multicomponent Exercise on Frailty in Long-Term Nursing Homes: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Jun;67(6):1145-1151. doi: 10.1111/jgs.15824. Epub 2019 Mar 19.
PubMed 30891748
Rezola-Pardo C, Arrieta H, Gil SM, Yanguas JJ, Iturburu M, Irazusta J, Sanz B, Rodriguez-Larrad A. A randomized controlled trial protocol to test the efficacy of a dual-task multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: Aging-ONDUAL-TASK study. BMC Geriatr. 2019 Jan 8;19(1):6. doi: 10.1186/s12877-018-1020-z.
PubMed 30626341
Arrieta H, Rezola-Pardo C, Echeverria I, Iturburu M, Gil SM, Yanguas JJ, Irazusta J, Rodriguez-Larrad A. Physical activity and fitness are associated with verbal memory, quality of life and depression among nursing home residents: preliminary data of a randomized controlled trial. BMC Geriatr. 2018 Mar 27;18(1):80. doi: 10.1186/s12877-018-0770-y.
PubMed 29580209
Arrieta H, Rezola-Pardo C, Gil SM, Irazusta J, Rodriguez-Larrad A. Physical training maintains or improves gait ability in long-term nursing home residents: A systematic review of randomized controlled trials. Maturitas. 2018 Mar;109:45-52. doi: 10.1016/j.maturitas.2017.12.003. Epub 2017 Dec 6.
PubMed 29452781
Arrieta H, Rezola-Pardo C, Zarrazquin I, Echeverria I, Yanguas JJ, Iturburu M, Gil SM, Rodriguez-Larrad A, Irazusta J. A multicomponent exercise program improves physical function in long-term nursing home residents: A randomized controlled trial. Exp Gerontol. 2018 Mar;103:94-100. doi: 10.1016/j.exger.2018.01.008. Epub 2018 Jan 8.
PubMed 29326087
de Souto Barreto P, Morley JE, Chodzko-Zajko W, H Pitkala K, Weening-Djiksterhuis E, Rodriguez-Manas L, Barbagallo M, Rosendahl E, Sinclair A, Landi F, Izquierdo M, Vellas B, Rolland Y; International Association of Gerontology and Geriatrics - Global Aging Research Network (IAGG-GARN) and the IAGG European Region Clinical Section. Recommendations on Physical Activity and Exercise for Older Adults Living in Long-Term Care Facilities: A Taskforce Report. J Am Med Dir Assoc. 2016 May 1;17(5):381-92. doi: 10.1016/j.jamda.2016.01.021. Epub 2016 Mar 21.
PubMed 27012368
Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
PubMed 23764209
Crocker T, Young J, Forster A, Brown L, Ozer S, Greenwood DC. The effect of physical rehabilitation on activities of daily living in older residents of long-term care facilities: systematic review with meta-analysis. Age Ageing. 2013 Nov;42(6):682-8. doi: 10.1093/ageing/aft133. Epub 2013 Sep 4.
PubMed 24004604
Brett L, Traynor V, Stapley P. Effects of Physical Exercise on Health and Well-Being of Individuals Living With a Dementia in Nursing Homes: A Systematic Review. J Am Med Dir Assoc. 2016 Feb;17(2):104-16. doi: 10.1016/j.jamda.2015.08.016. Epub 2015 Oct 1.
PubMed 26432622
Zucchella C, Bartolo M, Bernini S, Picascia M, Sinforiani E. Quality of life in Alzheimer disease: a comparison of patients' and caregivers' points of view. Alzheimer Dis Assoc Disord. 2015 Jan-Mar;29(1):50-4. doi: 10.1097/WAD.0000000000000050.
PubMed 24936799
Kasper JD, Black BS, Shore AD, Rabins PV. Evaluation of the validity and reliability of the Alzheimer Disease-related Quality of Life Assessment Instrument. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):275-84. doi: 10.1097/WAD.0b013e31819b02bc.
PubMed 19812471

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicomponent Physical Exercise Program: a Tool to Maintain Autonomy, Reduce Frailty and Improve Functionality in Nursing Homes. Interventional Single Group Study
ClinicalTrials.gov ID: NCT04221724
Acronym / sponsor ID: Functional-Ageing On
Conditions: Activities of Daily Living, Frailty, Older Adults, Long Term Care
Keywords: Exercise, Physical Activity, Aging
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: University of the Basque Country (UPV/EHU)University, hospital or other
Study start: 14 Jan 2019 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 9 Jan 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.

Participant will engage in an exercise program for 6 months in their nursing homes, in two sessions per week of 45-60 minutes

Detailed description

Primary aim:

The major aim is to ascertain whether multicomponent exercise program focused on function can maintain autonomy in older adults living in nursing homes.

Secondary aims:

To ascertain the influence of the evaluated exercise program on frailty, physical, psycho-affective and cognitive conditions in older people living in nursing homes.
Analyze if the influence that the exercise program has had on dependence, frailty, physical, psycho-affective and cognitive condition is maintained after 6 months since the end of the program
Examine the influence that the exercise program has on different clinical outcomes: falls, hospitalizations, visits to emergency service, the level of dependence, etc.

Design: experimental, multi-center and single-group physical exercise intervention

Intervention:

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Multicenter single group interventional study

Arm	Type	Receives
Intervention Group	Experimental	Other: Multicomponent physical exercise programMulticomponent physical exercise intervention

Who may qualify

Ages: 70 to 115 years
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Aged ≥70years
Scored ≥50 on the Barthel index
Scored ≥20 on Mini Examen Cognoscitive test (MEC-35), validated and adapted Spanish version of Mini Mental State Examination
Be able to stand up from the chair and walk 10 meters with or without one person/technical assistance.

Key exclusion criteria (3 listed)

If the participants are clinically unstable under the clinical judgment of the medical professionals of the reference center,
If the risk of adverse effects is greater than the benefit
If the participants have severe cognitive or psychiatric disorders.

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
Multicomponent physical exercise programThe intervention consists of a combined multicomponent exercise program (EP) carried out for 6 months that includes strength, balance, flexibility and functional exercises aimed to improve functioning on daily life activities. The EP will be divided into two parts: The first 3 months the EP aims to restore the physical condition through the multicomponent exercise program. This program will comprise of upper and lower body strengthening exercises, using external weights for 2-3sets of 8-12repetitions at a progressive intensity of 30-50% of 1RM. In addition, static balance and flexibility exercise will be performed. From 3th to 6th months, the objective will be to improve autonomy through the functional EP. Strength exercises intensity will be increased to 60-70% of 1-RM, 2-3sets of 8-12repetitions. Attention tasks, temporal space dissociation and dynamic balance exercises will be added to increase the intensity in balance exercises. Flexibility and fine handle will be also performed	Other	Intervention Group

Primary outcome

Barthel Index
Time frame: Changes from baseline to 3rd 6th and 12th month
Autonomy on daily living activities will be analyzed using the Barthel index. The Barthel index is a questionnaire with 10 items that evaluates the autonomy of the participant in the activities of daily life and it will be evaluated with the reference caregiver in nursing home. The Barthel index evaluates the following items: Feeding, Bathing, Dressing, Grooming, Bowels, Bladder, Toilette use, Transfer, Walking and Stairs. This items are scored as follows: 0 points if it is totally dependent, 5 points if needs some help and 10 points if the participant is totally autonomous
Short Physical Performance Battery
Time frame: Changes from baseline to 3rd 6th and 12th month
Short Physical Performance Battery (SPPB) evaluates balance, gait ability, and leg strength using a single tool. The score for each part is given in categorical modality (0-4). This set of tests serves to predict falls, weakness and mortality. The best score will be 12 points and total score less than 10 points indicates frailty and high risk of disability. 1 point of change in the total score has demonstrated to be of clinical relevance.
Handgrip strength
Time frame: Changes from baseline to 3rd 6th and 12th month
To asses upper limbs strength (kg) will be used bilateral handgrip strength test by squeezing a dynamometer with maximum isometric effort for 5 seconds. It is a strong predictor of disability, morbidity, and mortality as well as one of the components of Fried's frailty phenotype. Ranges are corrected by BMI
Timed Up and Go Test
Time frame: Changes from baseline to 3rd 6th and 12th month
Timed Up and Go (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The cut-off value for the TUG is 12 seconds The test score also correlates well with gait speed and the Barthel Index.

16 secondary outcomes

Fried frailty index
Time frame: Changes from baseline to 3rd 6th and 12th month
Tilburg frailty indicator
Time frame: Changes from baseline to 3rd 6th and 12th month
Rockwood frailty phenotype
Time frame: Changes from baseline to 3rd 6th and 12th month
Anthropometry-Weight
Time frame: Changes from baseline to 3rd 6th and 12th month
Anthropometry-Height
Time frame: Changes from baseline to 3rd 6th and 12th month
Body Mass Index
Time frame: Changes from baseline to 3rd 6th and 12th month
Anthropometry-Circumferences
Time frame: Changes from baseline to 3rd 6th and 12th month
The Goldberg Anxiety and Depression Scale
Time frame: Changes from baseline to 6th and 12th month
The Spanish Subjective Happiness scale
Time frame: Changes from baseline to 6th and 12th month
Quality of Life-Alzheimer Disease
Time frame: Changes from baseline to 6th and 12th month
Montreal Cognitive Assessment test (MOCA test)
Time frame: Changes from baseline to 6th and 12th month
Pain level
Time frame: Changes from baseline to 6th and 12th month
Clinical outcomes-Number of falls
Time frame: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
Clinical outcomes-visits to the emergency service
Time frame: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
Clinical outcomes-hospital admissions
Time frame: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
Clinical outcomes-functional impairment
Time frame: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months

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 27 Oct 2023.
Background: PubMed 28231827Rodriguez-Larrad A, Arrieta H, Rezola C, Kortajarena M, Yanguas JJ, Iturburu M, Susana MG, Irazusta J. Effectiveness of a multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: study protocol for a randomized clinical controlled trial. BMC Geriatr. 2017 Feb 23;17(1):60. doi: 10.1186/s12877-017-0453-0.
Background: PubMed 31845733Rezola-Pardo C, Rodriguez-Larrad A, Gomez-Diaz J, Lozano-Real G, Mugica-Errazquin I, Patino MJ, Bidaurrazaga-Letona I, Irazusta J, Gil SM. Comparison Between Multicomponent Exercise and Walking Interventions in Long-Term Nursing Homes: A Randomized Controlled Trial. Gerontologist. 2020 Sep 15;60(7):1364-1373. doi: 10.1093/geront/gnz177.
Background: PubMed 31787150Arrieta H, Rezola-Pardo C, Kortajarena M, Hervas G, Gil J, Yanguas JJ, Iturburu M, Gil SM, Irazusta J, Rodriguez-Larrad A. The impact of physical exercise on cognitive and affective functions and serum levels of brain-derived neurotrophic factor in nursing home residents: A randomized controlled trial. Maturitas. 2020 Jan;131:72-77. doi: 10.1016/j.maturitas.2019.10.014. Epub 2019 Nov 5.
Background: PubMed 31595289Rezola-Pardo C, Arrieta H, Gil SM, Zarrazquin I, Yanguas JJ, Lopez MA, Irazusta J, Rodriguez-Larrad A. Comparison between multicomponent and simultaneous dual-task exercise interventions in long-term nursing home residents: the Ageing-ONDUAL-TASK randomized controlled study. Age Ageing. 2019 Nov 1;48(6):817-823. doi: 10.1093/ageing/afz105.
Background: PubMed 30891748Arrieta H, Rezola-Pardo C, Gil SM, Virgala J, Iturburu M, Anton I, Gonzalez-Templado V, Irazusta J, Rodriguez-Larrad A. Effects of Multicomponent Exercise on Frailty in Long-Term Nursing Homes: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Jun;67(6):1145-1151. doi: 10.1111/jgs.15824. Epub 2019 Mar 19.
Background: PubMed 30626341Rezola-Pardo C, Arrieta H, Gil SM, Yanguas JJ, Iturburu M, Irazusta J, Sanz B, Rodriguez-Larrad A. A randomized controlled trial protocol to test the efficacy of a dual-task multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: Aging-ONDUAL-TASK study. BMC Geriatr. 2019 Jan 8;19(1):6. doi: 10.1186/s12877-018-1020-z.
Background: PubMed 29580209Arrieta H, Rezola-Pardo C, Echeverria I, Iturburu M, Gil SM, Yanguas JJ, Irazusta J, Rodriguez-Larrad A. Physical activity and fitness are associated with verbal memory, quality of life and depression among nursing home residents: preliminary data of a randomized controlled trial. BMC Geriatr. 2018 Mar 27;18(1):80. doi: 10.1186/s12877-018-0770-y.
Background: PubMed 29452781Arrieta H, Rezola-Pardo C, Gil SM, Irazusta J, Rodriguez-Larrad A. Physical training maintains or improves gait ability in long-term nursing home residents: A systematic review of randomized controlled trials. Maturitas. 2018 Mar;109:45-52. doi: 10.1016/j.maturitas.2017.12.003. Epub 2017 Dec 6.
Background: PubMed 29326087Arrieta H, Rezola-Pardo C, Zarrazquin I, Echeverria I, Yanguas JJ, Iturburu M, Gil SM, Rodriguez-Larrad A, Irazusta J. A multicomponent exercise program improves physical function in long-term nursing home residents: A randomized controlled trial. Exp Gerontol. 2018 Mar;103:94-100. doi: 10.1016/j.exger.2018.01.008. Epub 2018 Jan 8.
Background: PubMed 27012368de Souto Barreto P, Morley JE, Chodzko-Zajko W, H Pitkala K, Weening-Djiksterhuis E, Rodriguez-Manas L, Barbagallo M, Rosendahl E, Sinclair A, Landi F, Izquierdo M, Vellas B, Rolland Y; International Association of Gerontology and Geriatrics - Global Aging Research Network (IAGG-GARN) and the IAGG European Region Clinical Section. Recommendations on Physical Activity and Exercise for Older Adults Living in Long-Term Care Facilities: A Taskforce Report. J Am Med Dir Assoc. 2016 May 1;17(5):381-92. doi: 10.1016/j.jamda.2016.01.021. Epub 2016 Mar 21.
Background: PubMed 23764209Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
Background: PubMed 24004604Crocker T, Young J, Forster A, Brown L, Ozer S, Greenwood DC. The effect of physical rehabilitation on activities of daily living in older residents of long-term care facilities: systematic review with meta-analysis. Age Ageing. 2013 Nov;42(6):682-8. doi: 10.1093/ageing/aft133. Epub 2013 Sep 4.
Individual participant dataSharing planned: No

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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.

Jon Irazusta Astiazaran, Professor study director

University of the Basque Country (UPV/EHU)

Ana Rodriguez Larrad, PhD study director

University of the Basque Country (UPV/EHU)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent physical exercise program in people with Activities of Daily Living and Frailty, run by University of the Basque Country (UPV/EHU) 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 4 inclusion and 3 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 27 Oct 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 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?

Barthel Index (time frame: Changes from baseline to 3rd 6th and 12th month). The study lists 4 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 NCT04221724, which also lists 28 linked publications.

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 27 Oct 2023.