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Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program

Primary Purpose

Frailty, Disability Physical, Hospital Acquired Condition

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Exercise
Sponsored by
Fundacion Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 75 years
  • Barthel Index ≥60 points
  • Able to ambulate (with/without assistance)
  • Sing the informed consent
  • Able to communicate

Exclusion Criteria:

  • Expected length of stay <6 days
  • Terminal illness
  • Very severe cognitive decline (i.e., GDS 7)
  • Uncontrolled arrhythmias, acute pulmonary embolism and myocardial infarction, or extremity bone fracture in the past 3 months.

Sites / Locations

  • Complejo Hospitalario de Navarra. Department of Geriatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training group

Usual care group

Arm Description

Multicomponent exercise group (intervention): The intervention will consist of a multicomponent exercise training programme24, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening). The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RMcombined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.

Usual care

Outcomes

Primary Outcome Measures

Rate of patients with change in functional and cognitive status
The functional capacity of participants will be evaluated by the Short Physical Performance Battery (SPPB), the total score ranging from 0 (worst) to 12 points (best) which includes balance, gait and rising from a chair test. Standing balance test consists in the ability to maintain the standing position for 10s with three different foot position: parallel, semi-tandem and tandem. Walking speed measure, the time needed to progress for 4 linear meters with patient's usual speed, assigning a different score according to speed. Chair sit-to-stand assesses the ability to stand from a chair 5 consecutive times without using arms. The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality.

Secondary Outcome Measures

Rate of changes in the quality of life
- Changes in the quality of life measured by the Spanish version40 of the questionnaire EuroQol-5 Dimension (EQ-5D)41. It is an instrument measures 5 dimensions health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated according to the following levels: a) no problems; b) some problems; c) extreme problems. Besides, it contain visual analogy scale to quantify perceived health of 0 (worst health state imaginable) to 100 (best health state imaginable).
Number of patients with delirium
Development of delirium as assessed with the Confusion Assessment Method (CAM); feature 1, acute onset and fluctuating course; feature 2, inattention; feature 3, disorganized thinking; and feature 4, altered level of consciousness, with diagnosis of delirium requiring the presence of features 1 and 2 and either 3 or 442.
Mortality Rate
3-years mortality
Total use of health-related resources
Number of readmissions, visits to A&E, visits to outpatient clinics

Full Information

First Posted
October 19, 2020
Last Updated
July 12, 2021
Sponsor
Fundacion Miguel Servet
Collaborators
Universidad Pública de Navarra, Complejo Hospitalario de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT04600453
Brief Title
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program
Official Title
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Elderly: Study Protocol for a Randomized Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet
Collaborators
Universidad Pública de Navarra, Complejo Hospitalario de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The hospitalized elderly patient is conditioned by a series of circumstances unrelated to the pathological process itself that caused hospital admission and that usually worsen the results of hospitalization. In fact, the implementation of care models different from the traditional ones has shown a clear benefit in the functional results of these patients in the short and medium term. However, the components of these models that explain these better results have not been differentially evaluated. Some examples of these circumstances are the usual orders of absolute rest without any objective criteria for patients who are able to wander, the perpetuation of continuous fluid therapy, physical and chemical restraints, unnecessary permanent probes, etc. On numerous occasions, hospitalized elderly patients spend most of their time in bed, reaching even more than 83% of bedridden compared to 4% of those who stand up or are walking. The average time that a geriatric patient walks during their hospitalization ranges from 7 to 43 minutes/day. This population, by having their functional and physiological reserve reduced, are more vulnerable to the effects, for example, of bedridden, which range from functional loss or cognitive impairment, to longer stays, mortality and institutionalization, worse emotional situation, delirium, deconditioning, aspirations, pressure ulcers, and falls, decreased caloric intake, social isolation, poorer quality of life, and greater use of health-related resources. This study is a multicenter randomized clinical trial to be conducted in the acute care for elderly (ACE) units of three tertiary hospitals in Spain - Complejo Hospitalario de Navarra (CHN), Hospital Central de la Cruz Roja de Madrid (HCCRM) and Complejo Hospitalario Universitario of Albacete (CHUA). After randomization, the research team (physiotherapist, sport science specialist and geriatrician) will together perform the baseline measurement and follow-up visits of functional, pharmacological, comorbidity and cognitive assessment, as well as of mobility and strength evaluations. The intervention will consist of a multicomponent exercise training programme, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Disability Physical, Hospital Acquired Condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Experimental
Arm Description
Multicomponent exercise group (intervention): The intervention will consist of a multicomponent exercise training programme24, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening). The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RMcombined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Other Intervention Name(s)
Multicomponent exercise intervention
Intervention Description
The intervention will consist of a multicomponent exercise training programme24, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day. The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RM combined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.
Primary Outcome Measure Information:
Title
Rate of patients with change in functional and cognitive status
Description
The functional capacity of participants will be evaluated by the Short Physical Performance Battery (SPPB), the total score ranging from 0 (worst) to 12 points (best) which includes balance, gait and rising from a chair test. Standing balance test consists in the ability to maintain the standing position for 10s with three different foot position: parallel, semi-tandem and tandem. Walking speed measure, the time needed to progress for 4 linear meters with patient's usual speed, assigning a different score according to speed. Chair sit-to-stand assesses the ability to stand from a chair 5 consecutive times without using arms. The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Rate of changes in the quality of life
Description
- Changes in the quality of life measured by the Spanish version40 of the questionnaire EuroQol-5 Dimension (EQ-5D)41. It is an instrument measures 5 dimensions health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated according to the following levels: a) no problems; b) some problems; c) extreme problems. Besides, it contain visual analogy scale to quantify perceived health of 0 (worst health state imaginable) to 100 (best health state imaginable).
Time Frame
3 years
Title
Number of patients with delirium
Description
Development of delirium as assessed with the Confusion Assessment Method (CAM); feature 1, acute onset and fluctuating course; feature 2, inattention; feature 3, disorganized thinking; and feature 4, altered level of consciousness, with diagnosis of delirium requiring the presence of features 1 and 2 and either 3 or 442.
Time Frame
3 years
Title
Mortality Rate
Description
3-years mortality
Time Frame
3 years
Title
Total use of health-related resources
Description
Number of readmissions, visits to A&E, visits to outpatient clinics
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 75 years Barthel Index ≥60 points Able to ambulate (with/without assistance) Sing the informed consent Able to communicate Exclusion Criteria: Expected length of stay <6 days Terminal illness Very severe cognitive decline (i.e., GDS 7) Uncontrolled arrhythmias, acute pulmonary embolism and myocardial infarction, or extremity bone fracture in the past 3 months.
Facility Information:
Facility Name
Complejo Hospitalario de Navarra. Department of Geriatrics
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program

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