- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600453
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Elderly: Study Protocol for a Randomized Multicenter Clinical Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Navarra
-
Pamplona, Navarra, Spain, 31008
- Complejo Hospitalario de Navarra. Department of Geriatrics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care group
Usual care
|
|
Experimental: Training group
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of patients with change in functional and cognitive status
Time Frame: 3 years
|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of changes in the quality of life
Time Frame: 3 years
|
- 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).
|
3 years
|
Number of patients with delirium
Time Frame: 3 years
|
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.
|
3 years
|
Mortality Rate
Time Frame: 3 years
|
3-years mortality
|
3 years
|
Total use of health-related resources
Time Frame: 3 years
|
Number of readmissions, visits to A&E, visits to outpatient clinics
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MULTICENAG002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
Instituto Tecnologico y de Estudios Superiores...Not yet recruiting
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
The Hong Kong Polytechnic UniversityCompleted
-
Xijing HospitalUnknownFrailty SyndromeChina
-
Region ZealandUniversity of Southern DenmarkActive, not recruitingFrailty SyndromeDenmark
-
Neurological Associates of West Los AngelesEnrolling by invitation
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompleted
-
University of Erlangen-Nürnberg Medical SchoolCompleted
Clinical Trials on Physical Exercise
-
Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
-
Universidade Estadual da ParaibaUniversity of Campinas, BrazilUnknown
-
Instituto de Cardiologia do Rio Grande do SulFundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, BrazilTerminatedObesity | Sedentary Lifestyle | Hypercholesterolemia | High Blood PressureBrazil
-
Clarice Maria de Lucena MartinsCompletedMetabolic Diseases | Physical Activity
-
Cardiff UniversityCompletedParkinson's DiseaseUnited Kingdom
-
Instituto Materno Infantil Prof. Fernando FigueiraCompleted
-
McGill UniversityUniversité du Québec à Trois-Rivières; Université de Montréal; Concordia University... and other collaboratorsRecruiting
-
National Research Centre for the Working Environment...CompletedMusculoskeletal DisordersDenmark
-
Universidad Católica San Antonio de MurciaCompleted
-
Göteborg UniversityVastra Gotaland Region; Sahlgrenska University Hospital, SwedenCompletedChronic Widespread PainSweden