Multicomponent Exercise vs Walking Intervention in Nursing Home Residents

NCT03996083 | Completed

• 1 other identifier: 2019
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

aging; nursing homes; accidental falls; exercise

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery

  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.

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

Secondary Outcomes (22)

• 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)

• Senior Fitness Test: flexibility

  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)

Study Arms (2)

Multicomponent exercise intervention

EXPERIMENTAL

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.

Other: Multicomponent exercise intervention

Walking intervention

EXPERIMENTAL

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.

Other: Walking intervention

Interventions

Multicomponent exercise intervention 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.

Multicomponent exercise intervention

Walking intervention 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.

Walking intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

Basque Country

Leioa, Bizkaia, 48040, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Susana M Gil, MD, PhD

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: participants were randomized (in a 1:1 ratio) through sealed opaque envelopes by coin-tossing sequence generation into either the multicomponent or the walking group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 24, 2019
• Study Start: February 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06

Locations

ES (1)