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A Multicomponent Physical Exercise Program: a Tool to Maintain Autonomy, Reduce Frailty and Improve Functionality in Nursing Homes

Primary Purpose

Activities of Daily Living, Frailty, Older Adults

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent physical exercise program
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Activities of Daily Living focused on measuring Exercise, Physical Activity, Aging

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Basque Country University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Multicomponent physical exercise intervention

Outcomes

Primary Outcome Measures

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
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.
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
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.

Secondary Outcome Measures

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.
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
Rockwood frailty phenotype
9 phenotype ranging from very fit to terminally ill are evaluated in Rockwood frailty scale.
Anthropometry-Weight
Weight (kg)
Anthropometry-Height
Height (m)
Body Mass Index
Body Mass Index (BMI), weight and height will be combined to report BMI in kg/m^2)
Anthropometry-Circumferences
Neck circumference, mid arm circumference and calf circumference (cm)
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.
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.
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.
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
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
Clinical outcomes-Number of falls
Number of falls will be assessed with a clinical questionnaire
Clinical outcomes-visits to the emergency service
Visits to the emergency service will be assessed with a clinical questionnaire
Clinical outcomes-hospital admissions
Hospital admissions will be assessed with a clinical questionnaire
Clinical outcomes-functional impairment
Functional impairment after hospitalization will be assessed with a clinical questionnaire

Full Information

First Posted
January 3, 2020
Last Updated
January 26, 2021
Sponsor
University of the Basque Country (UPV/EHU)
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1. Study Identification

Unique Protocol Identification Number
NCT04221724
Brief Title
A Multicomponent Physical Exercise Program: a Tool to Maintain Autonomy, Reduce Frailty and Improve Functionality in Nursing Homes
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Basque Country (UPV/EHU)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Activities of Daily Living, Frailty, Older Adults, Long Term Care, International Classification of Functioning, Disability and Health
Keywords
Exercise, Physical Activity, Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter single group interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Multicomponent physical exercise intervention
Intervention Type
Other
Intervention Name(s)
Multicomponent physical exercise program
Intervention Description
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
Primary Outcome Measure Information:
Title
Barthel Index
Description
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
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Short Physical Performance Battery
Description
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.
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Handgrip strength
Description
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
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Timed Up and Go Test
Description
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.
Time Frame
Changes from baseline to 3rd 6th and 12th month
Secondary Outcome Measure Information:
Title
Fried frailty index
Description
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.
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Tilburg frailty indicator
Description
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
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Rockwood frailty phenotype
Description
9 phenotype ranging from very fit to terminally ill are evaluated in Rockwood frailty scale.
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Anthropometry-Weight
Description
Weight (kg)
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Anthropometry-Height
Description
Height (m)
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Body Mass Index
Description
Body Mass Index (BMI), weight and height will be combined to report BMI in kg/m^2)
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
Anthropometry-Circumferences
Description
Neck circumference, mid arm circumference and calf circumference (cm)
Time Frame
Changes from baseline to 3rd 6th and 12th month
Title
The Goldberg Anxiety and Depression Scale
Description
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.
Time Frame
Changes from baseline to 6th and 12th month
Title
The Spanish Subjective Happiness scale
Description
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.
Time Frame
Changes from baseline to 6th and 12th month
Title
Quality of Life-Alzheimer Disease
Description
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.
Time Frame
Changes from baseline to 6th and 12th month
Title
Montreal Cognitive Assessment test (MOCA test)
Description
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
Time Frame
Changes from baseline to 6th and 12th month
Title
Pain level
Description
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
Time Frame
Changes from baseline to 6th and 12th month
Title
Clinical outcomes-Number of falls
Description
Number of falls will be assessed with a clinical questionnaire
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
Title
Clinical outcomes-visits to the emergency service
Description
Visits to the emergency service will be assessed with a clinical questionnaire
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
Title
Clinical outcomes-hospital admissions
Description
Hospital admissions will be assessed with a clinical questionnaire
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
Title
Clinical outcomes-functional impairment
Description
Functional impairment after hospitalization will be assessed with a clinical questionnaire
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Irazusta Astiazaran, Professor
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana Rodriguez Larrad, PhD
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Study Director
Facility Information:
Facility Name
Basque Country University
City
Leioa
State/Province
Bizkaia
ZIP/Postal Code
48940
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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A Multicomponent Physical Exercise Program: a Tool to Maintain Autonomy, Reduce Frailty and Improve Functionality in Nursing Homes

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