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

October 25, 2023 updated by: Itxaso Mugica Errazquin, University of the Basque Country (UPV/EHU)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Bizkaia
      • Leioa, Bizkaia, Spain, 48940
        • Basque Country University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Multicomponent physical exercise intervention
Other: Multicomponent physical exercise program

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Changes from baseline to 3rd 6th and 12th month
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.
Changes from baseline to 3rd 6th and 12th month
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
Changes from baseline to 3rd 6th and 12th month
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.
Changes from baseline to 3rd 6th and 12th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fried frailty index
Time Frame: Changes from baseline to 3rd 6th and 12th month
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.
Changes from baseline to 3rd 6th and 12th month
Tilburg frailty indicator
Time Frame: Changes from baseline to 3rd 6th and 12th month
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
Changes from baseline to 3rd 6th and 12th month
Rockwood frailty phenotype
Time Frame: Changes from baseline to 3rd 6th and 12th month
9 phenotype ranging from very fit to terminally ill are evaluated in Rockwood frailty scale.
Changes from baseline to 3rd 6th and 12th month
Anthropometry-Weight
Time Frame: Changes from baseline to 3rd 6th and 12th month
Weight (kg)
Changes from baseline to 3rd 6th and 12th month
Anthropometry-Height
Time Frame: Changes from baseline to 3rd 6th and 12th month
Height (m)
Changes from baseline to 3rd 6th and 12th month
Body Mass Index
Time Frame: Changes from baseline to 3rd 6th and 12th month
Body Mass Index (BMI), weight and height will be combined to report BMI in kg/m^2)
Changes from baseline to 3rd 6th and 12th month
Anthropometry-Circumferences
Time Frame: Changes from baseline to 3rd 6th and 12th month
Neck circumference, mid arm circumference and calf circumference (cm)
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 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.
Changes from baseline to 6th and 12th month
The Spanish Subjective Happiness scale
Time Frame: Changes from baseline to 6th and 12th month
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.
Changes from baseline to 6th and 12th month
Quality of Life-Alzheimer Disease
Time Frame: Changes from baseline to 6th and 12th month
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.
Changes from baseline to 6th and 12th month
Montreal Cognitive Assessment test (MOCA test)
Time Frame: Changes from baseline to 6th and 12th month
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
Changes from baseline to 6th and 12th month
Pain level
Time Frame: Changes from baseline to 6th and 12th month
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
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
Number of falls will be assessed with a clinical questionnaire
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
Visits to the emergency service will be assessed with a clinical questionnaire
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
Hospital admissions will be assessed with a clinical questionnaire
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
Functional impairment after hospitalization will be assessed with a clinical questionnaire
The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Basque Country (UPV/EHU)

Investigators

  • Study Director: Jon Irazusta Astiazaran, Professor, University of the Basque Country (UPV/EHU)
  • Study Director: Ana Rodriguez Larrad, PhD, University of the Basque Country (UPV/EHU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

January 3, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Functional-Ageing On

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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