Multicomponent Exercise vs Walking Intervention in Nursing Home Residents

NCT ID: NCT03996083

Last Updated: 2019-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-05-01

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Multicomponent exercise intervention

The multicomponent exercise program consisted of strength and balance exercises performed on two non-consecutive days per week and lasting approximately an hour per session. Strength exercises were mainly focused on lower limb strengthening. A gradual and progressive intensity starting at 40% 1-RM and up 70% 1-RM was used. As for balance exercises, the first weeks consisted of mainly less complex static balance exercises and progressed to more complex and dynamic balance exercises. These exercises included standing with their feet together, semi-tandem, tandem and one-legged stand positions and moving on to dynamic exercises (circuits, stepping and so on). Difficulty was increased by reducing arm and base support and by varying the type and complexity of exercises. An individualized progression was applied to each participant based on their progress throughout the intervention.

Group Type: EXPERIMENTAL

Multicomponent exercise intervention

Intervention Type: OTHER

Strength exercises were focused on lower limb strengthening. Individual bilateral intensities were calculated to estimate one repetition maximum (1-RM) for the leg and arm. This test was performed on the 2nd and 7th weeks of the intervention. A gradual and progressive intensity starting at 40% 1-RM and up 70% 1-RM was used. No external loads were applied to the rest of the exercises due to their complex execution technique and subsequent risk of adverse events. In these cases, training progression was achieved through volume (number of repetitions) and execution velocity increments.

Balance exercises included standing with their feet together, semi-tandem, tandem and one-legged stand positions and moving on to dynamic exercises (circuits, stepping and so on). Difficulty was increased by reducing arm and base support and by varying the type and complexity of exercises. An individualized progression was applied to each participant based on their progress throughout the intervention.

Walking intervention

Participants assigned to the walking group walked with the research staff two days per week; additionally, they walked partially supervised by LTNH staff, family members or caregivers the rest of the week. Daily walking goals were set follows: walking between 5 to 10 minutes on the first month, up to 15 minutes on the second, and finally 20 minutes per day on the third month. The final goal was to get as close as possible to the recommendations of engaging in 150 minutes of aerobic exercise per week from the World Health Organization (WHO). Participants were asked to walk as fast as they could and rest was allowed whenever needed. Walking goals were achieved in one or multiple sessions, depending on each participant´s capacities. Those participants that met the walking goals without any rest were encouraged to walk at a faster pace.

Group Type: EXPERIMENTAL

Walking intervention

Intervention Type: OTHER

To comply with the walking goals, walking distance was calculated based on each participant´s performance on the 6-minute walking test and using a rule of thumb. Therefore, every participant had an itinerary to follow to comply with the minimum walking time each week. Distance rather than time was used with participants for practical reasons and the inability of most of them to measure time. Moreover, time and distance were individually adapted according to each participant´s performance on the previous week.

To ensure that participants complied with the walking goals, each of them (if they were cognitively able) was given a record sheet in which they had to write down their everyday walking routines. In addition, the caregivers were also informed about the walking routines and ensured that those participants who needed close supervision had someone to walk with and filled the sheet of those that were unable to do so.

Interventions

Multicomponent exercise intervention

Strength exercises were focused on lower limb strengthening. Individual bilateral intensities were calculated to estimate one repetition maximum (1-RM) for the leg and arm. This test was performed on the 2nd and 7th weeks of the intervention. A gradual and progressive intensity starting at 40% 1-RM and up 70% 1-RM was used. No external loads were applied to the rest of the exercises due to their complex execution technique and subsequent risk of adverse events. In these cases, training progression was achieved through volume (number of repetitions) and execution velocity increments.

Balance exercises included standing with their feet together, semi-tandem, tandem and one-legged stand positions and moving on to dynamic exercises (circuits, stepping and so on). Difficulty was increased by reducing arm and base support and by varying the type and complexity of exercises. An individualized progression was applied to each participant based on their progress throughout the intervention.

Intervention Type: OTHER

Walking intervention

To comply with the walking goals, walking distance was calculated based on each participant´s performance on the 6-minute walking test and using a rule of thumb. Therefore, every participant had an itinerary to follow to comply with the minimum walking time each week. Distance rather than time was used with participants for practical reasons and the inability of most of them to measure time. Moreover, time and distance were individually adapted according to each participant´s performance on the previous week.

To ensure that participants complied with the walking goals, each of them (if they were cognitively able) was given a record sheet in which they had to write down their everyday walking routines. In addition, the caregivers were also informed about the walking routines and ensured that those participants who needed close supervision had someone to walk with and filled the sheet of those that were unable to do so.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: lead

Responsible Party

Susana Gil

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susana M Gil, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Basque Country (UPV/EHU)

Locations

Basque Country

Leioa, Bizkaia, Spain

Countries

Spain

Other Identifiers

2019

Identifier Type: -

Identifier Source: org_study_id