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

NCT04221724 | Completed

• 1 other identifier: Functional-Ageing On
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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. An individualized and progressive multi-component physical exercise program focused on function has been designed to achieve this objective. Participant will engage in an exercise program for 6 months in their nursing homes, in two sessions per week of 45-60 minutes

Conditions

Activities of Daily Living; Frailty; Older Adults; Long Term Care

Keywords

Exercise; Physical Activity; Aging

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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

  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.

  Changes from baseline to 3rd 6th and 12th month

Secondary Outcomes (16)

• Fried frailty index

  Changes from baseline to 3rd 6th and 12th month

• Tilburg frailty indicator

  Changes from baseline to 3rd 6th and 12th month

• Rockwood frailty phenotype

  Changes from baseline to 3rd 6th and 12th month

• Anthropometry-Weight

  Changes from baseline to 3rd 6th and 12th month

• Anthropometry-Height

  Changes from baseline to 3rd 6th and 12th month

Study Arms (1)

Intervention Group

EXPERIMENTAL

Multicomponent physical exercise intervention

Other: Multicomponent physical exercise program

Interventions

Multicomponent physical exercise program OTHER

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

Intervention Group

Eligibility Criteria

• Age: 70 Years - 115 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

Basque Country University

Leioa, Bizkaia, 48940, Spain

Location

Related Publications (28)

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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  BACKGROUND

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• Mugica-Errazquin I, Irazusta J, Kortajarena M, Elosegi S, Wu B, Qi X, Rodriguez-Larrad A, Rezola-Pardo C. Maintaining daily living activities in older adults: The impact of a functional exercise program in long-term nursing homes. A single-group pre-post intervention. Geriatr Nurs. 2024 Nov-Dec;60:215-224. doi: 10.1016/j.gerinurse.2024.09.003. Epub 2024 Sep 14.

  PMID: 39278126 DERIVED

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jon Irazusta Astiazaran, Professor

  University of the Basque Country (UPV/EHU)

  STUDY DIRECTOR

• Ana Rodriguez Larrad, PhD

  University of the Basque Country (UPV/EHU)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Multicenter single group interventional study

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 9, 2020
• Study Start: January 14, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)