Clinical trial NCT04221724: Effects of Function-focused Multicomponent Physical Exercise Program. Interventional Single Group 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Activities of Daily Living
Frailty
Older Adults
Long Term Care
Keywords: Exercise
Physical Activity
Aging
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 207
Sex: ALL
Minimum age (years): 70
Maximum age (years): 115
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter single group interventional study
Primary purpose: PREVENTION

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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Barthel Index
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Short Physical Performance Battery
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Handgrip strength
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Timed Up and Go Test
timeFrame: Changes from baseline to 3rd 6th and 12th month
Secondary outcomes:
measure: Fried frailty index
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Tilburg frailty indicator
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Rockwood frailty phenotype
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Anthropometry-Weight
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Anthropometry-Height
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Body Mass Index
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: Anthropometry-Circumferences
timeFrame: Changes from baseline to 3rd 6th and 12th month
measure: The Goldberg Anxiety and Depression Scale
timeFrame: Changes from baseline to 6th and 12th month
measure: The Spanish Subjective Happiness scale
timeFrame: Changes from baseline to 6th and 12th month
measure: Quality of Life-Alzheimer Disease
timeFrame: Changes from baseline to 6th and 12th month
measure: Montreal Cognitive Assessment test (MOCA test)
timeFrame: Changes from baseline to 6th and 12th month
measure: Pain level
timeFrame: Changes from baseline to 6th and 12th month
measure: Clinical outcomes-Number of falls
timeFrame: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
measure: Clinical outcomes-visits to the emergency service
timeFrame: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
measure: Clinical outcomes-hospital admissions
timeFrame: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
measure: Clinical outcomes-functional impairment
timeFrame: The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: Basque Country University
state: Bizkaia
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: Jon Irazusta Astiazaran, Professor
role: STUDY_DIRECTOR
affiliation: University of the Basque Country (UPV/EHU)
name: Ana Rodriguez Larrad, PhD
role: STUDY_DIRECTOR
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