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

U

University of the Basque Country (UPV/EHU)

Status

Completed

Conditions

Long Term Care
Older Adults
Frailty
Activities of Daily Living

Treatments

Other: Multicomponent physical exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT04221724
Functional-Ageing On

Details and patient eligibility

About

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

Full 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.

Enrollment

207 patients

Sex

All

Ages

70 to 115 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

207 participants in 1 patient group

Intervention Group
Experimental group
Description:
Multicomponent physical exercise intervention
Treatment:
Other: Multicomponent physical exercise program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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