Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study (Ros-Ita)
Primary Purpose
Frailty, Geriatric Syndromes, Functional Recovery
Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Frailty focused on measuring older adults, frailty, geriatric assessment, geriatric syndromes, multicomponent exercise program
Eligibility Criteria
Inclusion Criteria:
- Frailty
- Informed consent signature
Exclusion Criteria:
- Life expectancy less than 6 months
- Acute Ischemic coronariopathy event during the last three months
- Active cancer treatment (chemoteraphy or radiotherapy) during the last three months
- Major surgery during the last six months
Sites / Locations
- Hospital Universitario de la Ribera
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control Goup
Arm Description
Multicomponent exercise program twice a week (2 hours per week) during six months
Usual routine.
Outcomes
Primary Outcome Measures
Frailty reversion.
Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail
Intrinsic capacity
ICOPE questionnaire score
Quality of life objective and subjective
EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.
Polypharmacy
Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.
Cognitive state
Pfeiffer questionnaire
Depression
Yesavage's Geriatrics Depression Scale (15 items)
Nutrition state
Mini Nutritional Assessment Short Form. Score 0 to 14.
Falls
Number of falls during follow-up period
Sarcopenia
European Working Group on Sarcopenia in Older People (EWGSOP) criteria
Secondary Outcome Measures
Hospital admissions
Number of hospital admissions during follow-up period
Visits to General Practitioner (GP)
Number of visits to GP during follow-up period
Validation of a shaking measurement tool to asses muscle strength
Gold standard Hand grip measured by dinamometry
Validation of a gait speed mobile phone tool
Gold standard Gait speed measurement
Validation of a pulmonar capacity mobile phone tool
Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC)
Full Information
NCT ID
NCT04711785
First Posted
January 12, 2021
Last Updated
July 18, 2022
Sponsor
Hospital de la Ribera
Collaborators
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT04711785
Brief Title
Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study
Acronym
Ros-Ita
Official Title
Assessment of the Possible Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise Tutored at Home Through an Integrated Computer System. Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No recruitment possibility
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de la Ribera
Collaborators
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study has been designed to analyze the possible positive effects of a multicomponent physical exercise program monitored with an integrated electronic device system in dwelling-community frailty older adults.
The study will assess changes in physical, nutritional, cognitive, and psychological aspects after program finishes at six months.
Information will be collected by researchers at baseline, monthly and after study finishes.
Detailed Description
The aging process is associated with physiological changes that determine a decrease in functional reserve and limit the ability to respond to external factors.
Likewise, aging is associated with a deterioration of the regulatory processes that maintain the functional integration of the different organs and systems. A direct consequence of this phenomenon is the atypical presentation of highly prevalent diseases in the elderly. This atypical presentation of diseases in the elderly is responsible for the so-called geriatric syndromes, considered as specific nosological entities with a high frequency of presentation in the elderly, being included within the prevention, diagnosis and treatment strategies of geriatric medicine.
These syndromes can generate greater morbidity and consequences, sometimes more serious than the disease that produces them. Its systematic detection should be included in the anamnesis of the clinical history of the elderly. Geriatric syndromes are a group of conditions usually caused by the conjunction of diseases with a high prevalence in the elderly and which are the frequent origin of functional or social disability in the population. They are the manifestation of many diseases, but they are also the beginning of many other problems that we must take into account from their detection to establish a good prevention of them.
The hypothesis of this work is that in frail and pre-frail older adults who participate in an integrated program of multicomponent physical exercise tutored by means of an app will improve their functional situation and reverse their diagnoses of pre and frailty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Geriatric Syndromes, Functional Recovery
Keywords
older adults, frailty, geriatric assessment, geriatric syndromes, multicomponent exercise program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cohort study
Masking
None (Open Label)
Masking Description
Cohort study no masking presented.
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Multicomponent exercise program twice a week (2 hours per week) during six months
Arm Title
Control Goup
Arm Type
No Intervention
Arm Description
Usual routine.
Intervention Type
Behavioral
Intervention Name(s)
Multicomponent exercise program
Intervention Description
The exposed group will carry out the following program of specific muscle strength and cardio physical activity aimed at reducing frailty.
For 2.5 hours per week.
Primary Outcome Measure Information:
Title
Frailty reversion.
Description
Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail
Time Frame
Six months
Title
Intrinsic capacity
Description
ICOPE questionnaire score
Time Frame
Six months
Title
Quality of life objective and subjective
Description
EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.
Time Frame
Six months
Title
Polypharmacy
Description
Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.
Time Frame
Six months
Title
Cognitive state
Description
Pfeiffer questionnaire
Time Frame
Six months
Title
Depression
Description
Yesavage's Geriatrics Depression Scale (15 items)
Time Frame
Six months
Title
Nutrition state
Description
Mini Nutritional Assessment Short Form. Score 0 to 14.
Time Frame
Six months
Title
Falls
Description
Number of falls during follow-up period
Time Frame
Six months
Title
Sarcopenia
Description
European Working Group on Sarcopenia in Older People (EWGSOP) criteria
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Hospital admissions
Description
Number of hospital admissions during follow-up period
Time Frame
Six months
Title
Visits to General Practitioner (GP)
Description
Number of visits to GP during follow-up period
Time Frame
Six months
Title
Validation of a shaking measurement tool to asses muscle strength
Description
Gold standard Hand grip measured by dinamometry
Time Frame
six months
Title
Validation of a gait speed mobile phone tool
Description
Gold standard Gait speed measurement
Time Frame
Six months
Title
Validation of a pulmonar capacity mobile phone tool
Description
Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC)
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Frailty
Informed consent signature
Exclusion Criteria:
Life expectancy less than 6 months
Acute Ischemic coronariopathy event during the last three months
Active cancer treatment (chemoteraphy or radiotherapy) during the last three months
Major surgery during the last six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Tarazona Santabalbina, MD, PhD
Organizational Affiliation
Hospital Universitario de La Ribera
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de la Ribera
City
Alzira,
State/Province
Kingdom Of Valéncia
ZIP/Postal Code
46660
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30419096
Citation
Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869. Erratum In: JAMA Intern Med. 2019 Jan 1;179(1):127.
Results Reference
background
PubMed Identifier
24291597
Citation
Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27. Erratum In: Arch Phys Med Rehabil. 2018 Jan;99(1):211-212.
Results Reference
background
PubMed Identifier
30629631
Citation
Sanders LMJ, Hortobagyi T, la Bastide-van Gemert S, van der Zee EA, van Heuvelen MJG. Dose-response relationship between exercise and cognitive function in older adults with and without cognitive impairment: A systematic review and meta-analysis. PLoS One. 2019 Jan 10;14(1):e0210036. doi: 10.1371/journal.pone.0210036. eCollection 2019.
Results Reference
background
PubMed Identifier
26947059
Citation
Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.
Results Reference
result
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Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study
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