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FrailtyRos-ItaNCT04711785

Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study

A study testing Multicomponent exercise program in people with Frailty and Geriatric Syndromes, run by Hospital de la Ribera at 1 site in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Frailty, Geriatric Syndromes, Functional Recovery
What is being tested?
Multicomponent exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSpain
Study dates
1 Sep 2021to 31 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Frailty
  • Informed consent signature

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de la Ribera

    Alzira, Kingdom of Valéncia, 46660

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Multicomponent exercise program
Keywords
older adults, frailty, geriatric assessment, geriatric syndromes, multicomponent exercise program
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent exercise programBehavioural

    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.

Study groups in NCT04711785
Study groupRoleWhat they receive
InterventionActive comparatorMulticomponent exercise program twice a week (2 hours per week) during six months
Receives: Behavioral: Multicomponent exercise program
Control GoupNo interventionUsual routine.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frailty reversion.

    Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail

    Measured: Six months

  2. Intrinsic capacity

    ICOPE questionnaire score

    Measured: Six months

  3. Quality of life objective and subjective

    EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.

    Measured: Six months

  4. Polypharmacy

    Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.

    Measured: Six months

  5. Cognitive state

    Pfeiffer questionnaire

    Measured: Six months

  6. Depression

    Yesavage's Geriatrics Depression Scale (15 items)

    Measured: Six months

  7. Nutrition state

    Mini Nutritional Assessment Short Form. Score 0 to 14.

    Measured: Six months

  8. Falls

    Number of falls during follow-up period

    Measured: Six months

  9. Sarcopenia

    European Working Group on Sarcopenia in Older People (EWGSOP) criteria

    Measured: Six months

Secondary outcomes (5)

  1. Hospital admissions

    Number of hospital admissions during follow-up period

    Measured: Six months

  2. Visits to General Practitioner (GP)

    Number of visits to GP during follow-up period

    Measured: Six months

  3. Validation of a shaking measurement tool to asses muscle strength

    Gold standard Hand grip measured by dinamometry

    Measured: six months

  4. Validation of a gait speed mobile phone tool

    Gold standard Gait speed measurement

    Measured: Six months

  5. Validation of a pulmonar capacity mobile phone tool

    Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC)

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion1 Sep 2021 (estimated)
  4. Study completion31 Jan 2024 (estimated)

Why it stopped: No recruitment possibility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Cohort study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04711785
Sponsor's protocol ID
HRibera001-12012021
Acronym
Ros-Ita
Status last verified
Jul 2022
First submitted
12 Jan 2021
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30419096

  • 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.

    PubMed 24291597

  • 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.

    PubMed 30629631

  • 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.

    PubMed 26947059

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent exercise program in people with Frailty and Geriatric Syndromes, run by Hospital de la Ribera at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty reversion. (time frame: Six months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04711785, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.

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