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Clinical Trials/NCT03996083
NCT03996083
Completed
Not Applicable

A Randomized Controlled Trial to Compare a Multicomponent Exercise Program and a Walking Program in Long-term Nursing Home Residents

University of the Basque Country (UPV/EHU)1 site in 1 country81 target enrollmentFebruary 1, 2018
ConditionsAging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
University of the Basque Country (UPV/EHU)
Enrollment
81
Locations
1
Primary Endpoint
Short Physical Performance Battery
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Physical exercise is an important tool to tackle the deleterious effect of aging. However, which is the best exercise intervention is still unknown. Moreover, many exercise interventions are complicated to implement, particularly in nursing homes. In contrast, walking is a simple, natural, and familiar mode of exercise that is well tolerated by older adults. Thus, the objective was to assess and compare the effects of an individualized multicomponent exercise program and an individualized and progressive walking intervention on LTNH residents´ physical and cognitive performance, habitual physical activity, psycho-affective status and quality of life.

Detailed Description

The objective was to assess and compare the effects of an individualized multicomponent exercise program and an individualized and progressive walking intervention on LTNH residents´ physical and cognitive performance, habitual physical activity, psycho-affective status and quality of life. Design: single-blind randomized controlled trial. 81 men and women were randomly assigned to a multicomponent (MG) or a walking (WG) group after baseline measurements. Participants in the MG underwent a twice a week individualised and progressive multicomponent exercise program composed of strength and balance exercises. The walking group was also individualised and walked progressively to up to 20 minutes per day for the 3-month intervention. The primary outcome was the score on the Short Physical Performance Battery (lower limb strength (time needed to perform five chair stands), static balance (standing with feet together, semi-tandem and tandem positions) and usual gait speed (4m), assessed at baseline and after the intervention. Secondary outcomes included other relevant physical performance tests (Senior Fitness Test, the Berg Balance Scale, handgrip strength, usual gait speed (4m) the instrumented Timed Up and Go test), habitual physical activity (using accelerometers during 7 days), cognitive performance (Montreal Cognitive Assessment test and the Rey Auditory Verbal Learning Test), psycho-affective status (Anxiety and Depression Goldberg Scale, and loneliness using the Jong Gierveld loneliness scale) and quality of life (the Quality of Life Alzheimer´s disease scale). Also frailty and the number of falls and deaths will be registered. Descriptive statistics were computed and baseline (between group differences) and time effects (within group differences) were checked using Student´s-t test (quantitative variables) or Chi square test (qualitative variables). Intervention effects between groups were assessed by 2-way analysis of variance for repeated measures (group by time interactions). Partial η2 and Cohen´s d was calculated. All the analysis performed under the intention-to-treat principle and significance was set at p \< 0.05.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
May 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of the Basque Country (UPV/EHU)
Responsible Party
Principal Investigator
Principal Investigator

Susana Gil

Principal investigator

University of the Basque Country (UPV/EHU)

Eligibility Criteria

Inclusion Criteria

  • Score ≥ 50 on the Barthel Index (Wade and Collin, 1988)
  • ≥ 20 on the MEC-35 test (an adapted version of the Mini Mental State Examination, MMSE, validated in Spanish) (Lobo et al., 1999)
  • capable to stand up and walk with or without assistive devices for at least 10 m.
  • References:
  • Wade D.T., Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988; 10(2):64-
  • doi: 10.3109/
  • Lobo A, Saz P, Marcos G, Díaz J.L, de la Camara C, Ventura T, Morales Asín F, Fernando Pascual L, Montañes J.A, Aznar S. Revalidación y normali-zación del Mini-Examen Cognoscitivo (primera versión en castellano del Mini-Mental Status Exa- mination) en la población general geriátrica. Med Clin (Barc). 1999; 112; 767-774

Exclusion Criteria

  • Participants who were clinically unstable or who had any condition in which the medical staff considered it was not in the subject´s best interests to participate were not included in the study.

Outcomes

Primary Outcomes

Short Physical Performance Battery

Time Frame: Measurements will be made at baseline and after the intervention (3 months)

The Short Physical Performance Battery test (SPPB). It assesses Lower extremity function: static balance, gait speed and getting in and out of a chair. The participant undertakes different tests: Side-by-side, semi-tandem and tandem stands (10 seconds); 4 meters walk test at comfortable speed and 5 quickly sit to stand from a chair without upper extremity assistance. The outcome is a score 0-12 points. A higher score means better performance Reference: Guralnik et al, 1994. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994; 49(2):M85-94. doi: 10.1093/geronj/49.2.M85.

Secondary Outcomes

  • The Berg Balance Scale(Measurements will be made at baseline and after the intervention (3 months))
  • Usual gait speed (4m)(Measurements will be made at baseline and after the intervention (3 months))
  • de Jong Gierveld loneliness scale(Measurements will be made at baseline and after the intervention (3 months))
  • Handgrip strength(Measurements will be made at baseline and after the intervention (3 months))
  • Senior Fitness Test: flexibility(Measurements will be made at baseline and after the intervention (3 months))
  • Senior Fitness Test: strength of the upper extremities(Measurements will be made at baseline and after the intervention (3 months))
  • Senior Fitness Test: strength of the lower extremities(Measurements will be made at baseline and after the intervention (3 months))
  • Objectively measured habitual physical activity(Measurements will be made at baseline and after the intervention (3 months))
  • Senior Fitness Test: dynamic balance(Measurements will be made at baseline and after the intervention (3 months))
  • Senior Fitness Test: aerobic capacity(Measurements will be made at baseline and after the intervention (3 months))
  • The instrumented Timed Up and Go test(Measurements will be made at baseline and after the intervention (3 months))
  • Montreal Cognitive Assessment test(Measurements will be made at baseline and after the intervention (3 months))
  • Rey Auditory Verbal Learning Test(Measurements will be made at baseline and after the intervention (3 months))
  • Anxiety and Depression Goldberg Scale(Measurements will be made at baseline and after the intervention (3 months))
  • Quality of Life Alzheimer´s disease scale(Measurements will be made at baseline and after the intervention (3 months))
  • Anthropometric measurements: Height(Measurements will be made at baseline and after the intervention (3 months))
  • Anthropometric measurements: weight(Measurements will be made at baseline and after the intervention (3 months))
  • Anthropometric measurements: perimeters(Measurements will be made at baseline and after the intervention (3 months))
  • Frailty Tilburg(Measurements will be made at baseline and after the intervention (3 months))
  • Frailty Fried(Measurements will be made at baseline and after the intervention (3 months))
  • Falls(Measurements will be made at baseline and after the intervention (3 months))
  • Deaths(From baseline, during the intervention (3 months))

Study Sites (1)

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