Multicomponent Exercise vs Walking Intervention in Nursing Home Residents

Not Applicable

Completed

• Conditions: Aging

• Registration Number: NCT03996083
• Lead Sponsor: University of the Basque Country (UPV/EHU)

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-05-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Study First Posted: 2019-06-24
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery	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 Outcome Measures

Name	Time	Method
The Berg Balance Scale	Measurements will be made at baseline and after the intervention (3 months)	Estimates postural stability using different positions. Construct: Static balance. Scale range (total score): 0-56 (the higher, the better).; Reference: Berg et al, 1992. Measuring balance in the elderly: validation of an instrument. Can J Publ Health. 1992; 83:S7-11
Usual gait speed (4m)	Measurements will be made at baseline and after the intervention (3 months)	The participants walks at his/her usual and comfortable pace for 4 m, time is measured in seconds.; Reference: Bohannon et al, 1996. Walking speed: reference values and correlates for older adults. J Orthop Sports Phys Ther. 1996; 24(2):86-90. doi: 10.2519/jospt.1996.24.2.86.
de Jong Gierveld loneliness scale	Measurements will be made at baseline and after the intervention (3 months)	This questionnaire includes characteristics of the social network, background variables, personality characteristics, and evaluative aspects.; Construct: Loneliness perception. Scale range (total score): 0-11 (the higher, the worse).; Reference: De Jong Gierveld, J. (1987). Developing and testing a model of loneliness. Journal of Personality and Social Psychology, 53(1), 119-128.
Handgrip strength	Measurements will be made at baseline and after the intervention (3 months)	For that the participant squeezes the dynamometer with maximum isometric effort for about 5 seconds. It measures strength in kg.; Reference: Fess, 1992. Clinical assessment recommendations. 2. Casanova JS, editor. Chicago: American Society of Hand Therapists; 1992. Grip strength; pp. 41-45.
Senior Fitness Test: flexibility	Measurements will be made at baseline and after the intervention (3 months)	Performed test: chair sit and reach. The participant is sitting and tries to touch the toes. The distance between the fingers and the toes is measured (cm); Reference: Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Senior Fitness Test: strength of the upper extremities	Measurements will be made at baseline and after the intervention (3 months)	Number of arm curls performed in 30 seconds; Reference: Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Senior Fitness Test: strength of the lower extremities	Measurements will be made at baseline and after the intervention (3 months)	Number of Chair-stands performed in 30 seconds; Reference: Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Objectively measured habitual physical activity	Measurements will be made at baseline and after the intervention (3 months)	Active and sedentary periods during everyday life recorded with an accelerometer (Actigraph GT3X model (Actigraph LLC, Pensacola, FL, USA)) that is worn on the hip with a belt for a 7 day period. The device is set to quantify the number of steps taken per day. In line with that, active-period intensities will be classified following the criteria developed by Freedson et al., 1998 as low, medium or high intensity and measured in minutes.; Reference: Freedson et al, 1988. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998; 30(5):777-81. doi: 10.1097/00005768-199805000-00021.
Senior Fitness Test: dynamic balance	Measurements will be made at baseline and after the intervention (3 months)	8 Foot Up and Go test: The participant from a sitting positions, gets up and walks a 4 foot distance, turns and comes back. Time is measured in seconds.; Reference: Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Senior Fitness Test: aerobic capacity	Measurements will be made at baseline and after the intervention (3 months)	Performed test: 6-minutes walking test. The participant walks during 6 minutes as fast as possible without running. The distance is measured in meters; Reference: Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
The instrumented Timed Up and Go test	Measurements will be made at baseline and after the intervention (3 months)	The instrumented Timed Up and Go test, using a BTS Biomedical G-WALK triaxial accelerometer and gyroscope, to measure dynamic balance. The participant gets up from a chair, walks 3 meters at a normal pace, turns and walks back to sit down again.; Reference: Mathias et al, 1986. Balance in elderly patients: the "get-up and go" test. Arch Phys Med Rehabil. 1986; 67(6):387-9.
Montreal Cognitive Assessment test	Measurements will be made at baseline and after the intervention (3 months)	It assesses different cognitive domains: attention and concentration, executive functions, memory, language, constructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.; Reference: Coen et al, 2016.Strengths and Limitations of the MoCA for Assessing Cognitive Functioning Findings From a Large Representative Sample of Irish Older Adults. Journal of Geriatric Psychiatry and Neurology. 2016; 29(1):18-24. doi: 10.1177/0891988715598236.
Rey Auditory Verbal Learning Test	Measurements will be made at baseline and after the intervention (3 months)	It measures learning capacity. Evaluates short- and long-term verbal learning assessing the ability to learn a list of 15 common words.; Reference: Lezak MD, Howieson DB, Loring DW. Neuropsychological Assessment. 4th ed. New York: Oxford University Press; 2004
Anxiety and Depression Goldberg Scale	Measurements will be made at baseline and after the intervention (3 months)	It is used to assess the affective state. This questionnaire includes nine depression and nine anxiety items from the past month.; Construct: Anxiety and depression.; Scale range (Subescale score): 0-9 Anxiety (the higher, the worse). 0-9 Depression (the higher, the worse).; Reference: Goldberg et al, 1988. Detecting anxiety and depression in general medical settings. Br Med J. 1988; 297(6653):897-9. doi:10.1136/bmj.297.6653.897.
Quality of Life Alzheimer´s disease scale	Measurements will be made at baseline and after the intervention (3 months)	It measures the perceived quality of life, particularly, self-rated quality of life for people with cognitive impairments.; Construct: Health related quality of life. Scale range (total score): 13-52 (the higher, the better).; Reference: Logsdon et al., 2002. Assessing quality of life in older adults with cognitive impairment. Psychosomatic Medicine. 2002;64:510-519.
Anthropometric measurements: Height	Measurements will be made at baseline and after the intervention (3 months)	To measure heigt the participant stands up and distance form the top of the head to the floor is measured in cm.
Anthropometric measurements: weight	Measurements will be made at baseline and after the intervention (3 months)	Weight in Kg is measured usind a scale
Anthropometric measurements: perimeters	Measurements will be made at baseline and after the intervention (3 months)	Hip and waist perimeters are measured (in cm) using a tape measure.
Frailty Tilburg	Measurements will be made at baseline and after the intervention (3 months)	Tilburg Frailty index estimates frailty. Construct: Multidimensional frailty. Scale range (total score): 0-15 (the higher, the worse).; References: Gobbens et al., 2010. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 11(5):344-55. doi:10.1016/j.jamda.2009.11.003.
Frailty Fried	Measurements will be made at baseline and after the intervention (3 months)	Fried's Frailty index estimates frailty.; Construct: Frailty phenotype. Scale range (total score): 0-5 (the higher, the worse).; References: Fried et al., 2001. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 56(3):M146-56. doi: 10.1093/gerona/56.3.M146.
Falls	Measurements will be made at baseline and after the intervention (3 months)	Number of falls will be recorded from the medical records. Record from the last year and during the intervention will be recorded
Deaths	From baseline, during the intervention (3 months)	Number of deaths will be recorded during the intervention

Trial Locations

Locations (1)

Basque Country; 🇪🇸 Leioa, Bizkaia, Spain