Clinical trial NCT03996083: Multicomponent Exercise vs Walking Intervention in Nursing Home Residents
Official title: A Randomized Controlled Trial to Compare a Multicomponent Exercise Program and a Walking Program in Long-term Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: aging
nursing homes
accidental falls
exercise
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 81
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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):64-7. doi: 10.3109/09638288809164105.
* 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.

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
Secondary outcomes:
measure: Senior Fitness Test: strength of the upper extremities
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Senior Fitness Test: strength of the lower extremities
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Senior Fitness Test: flexibility
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Senior Fitness Test: dynamic balance
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Senior Fitness Test: aerobic capacity
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: The Berg Balance Scale
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Usual gait speed (4m)
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: The instrumented Timed Up and Go test
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Objectively measured habitual physical activity
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Montreal Cognitive Assessment test
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Rey Auditory Verbal Learning Test
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Anxiety and Depression Goldberg Scale
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Quality of Life Alzheimer´s disease scale
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: de Jong Gierveld loneliness scale
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Handgrip strength
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Anthropometric measurements: Height
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Anthropometric measurements: weight
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Anthropometric measurements: perimeters
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Frailty Tilburg
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Frailty Fried
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Falls
timeFrame: Measurements will be made at baseline and after the intervention (3 months)
measure: Deaths
timeFrame: From baseline, during the intervention (3 months)
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: Basque Country
state: Bizkaia
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: Susana M Gil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: