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Accidental FallsPhase 3FAREMAVANCT02631330

Effect on Falls Reduction of a Multimodal Intervention in Frail and Pre-frail Elderly Community-dwelling People

A Phase 3 study testing Multicomponent physical activity in people with Accidental Falls, run by Hospital de la Ribera at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Practice guidelines in caring for the geriatric population recommend performing an annual screening of falls . However, one of the problems that interfere with fall prevention programs is the lack of importance accorded to health professionals to falls. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Accidental Falls
What is being tested?
Multicomponent physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
466 participants
Where
1 siteSpain
Study dates
Dec 2015to Jul 2017
Phase
Phase 3
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 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Women and men with older than or equal to 70 years old.
  • Independent ambulation (may have technical aids but not someone else).
  • Usual residence in the areas of health described.
  • Linda Fried's Criteria of pre-frailty or frailty.

Who cannot join

  • Patients with life expectancy of less than six months.
  • Institutionalized patients.
  • Patients with severe hearing or visual deficits.
  • Patients with contraindication in physical exercise.
  • Patients with serious psychiatric illness or moderate or severe cognitive impairment.
  • Patients who refuse to sign the informed consent.

Trial locations and contacts

1 site in 1 country.

Francisco J Tarazona-Santabalbina, MD,PhD contact

962458100 ext. 8387

fjtarazona@hospital-ribera.com

Spain1 site, 1 recruiting
  • Hospital Universitario de la Ribera

    Alzira, Valéncia, 46600

    Francisco J Santabalbina, 962458100 ext. 8387, fjtarazona@hospital-ribera.com

    Pilar Pérez-Ros, PhD

    Recruiting

Other trials in Spain

About this study

Official title: Effect on Falls Reduction of a Multimodal Intervention in Frail and Pre-frail Elderly Community-dwelling People in Madeira Island (Portugal) and Valencia (Spain)

Practice guidelines in caring for the geriatric population recommend performing an annual screening of falls . However, one of the problems that interfere with fall prevention programs is the lack of importance accorded to health professionals to falls. This lack of awareness of the risks faced by the associated geriatric population falls generates reluctance to adherence to a fall prevention program . At European level there are the same gaps in knowledge about the real effectiveness and efficiency of fall prevention programs .

HYPOTHESIS: The implementation of a multicomponent fall prevention program in frail and pre-frail elderly community-dwelling people reduce the incidence of falls.

Read more

OBJECTIVES

General:

  • To determine the efficacy of a comprehensive program to prevent falls in the community.

Specific:

  • Knowing whether reducing the incidence of falls implies a reduction in visits to primary care, emergency department or hospital staying.
  • Knowing the adhesion, through indirect measures, to the intervention program.
  • Knowing the nutritional, functional, cognitive, social, anthropometric, respiratory and clinical profile, including falls, of the sample.

MATERIAL AND METHODS

Study design:

Multicenter community intervention study, longitudinal, prospective, randomized, and experimental.

Through intervention by nurses in primary care education of subjects over 70 years it is to know the effectiveness of a comprehensive program of falls prevention.

It will proceed to recruit older than or equal to 70 years subjects, who meet frailty criteria age, belonging to the areas of Madeira Island (Portugal) and La Ribera County (Valéncia, Spain) .

Read the detailed description

INTRODUCTION The World Health Organization (WHO) defines fall as a result of any event precipitating the patient down, involuntarily .

Along with instability and gait disturbances, falls are one of the great geriatric syndromes and are the second cause of death worldwide by unintentional injuries.

In the field of public health, falls in the elderly are considered a major biopsychosocial problem due to medical, psychological, social and family and economic consequences. It is estimated that in 2020 the cost generated to the social and health care by falls will be about 30,000 million euros. This is because about 20% of falls require medical attention, with approximately 10% of consultations in emergency services and 6% of urgent hospitalization in the elderly .

Mortality in elderly people as a result of falls is nearly 40,000 deaths annually in Europe, obtaining in Spain a mortality rate 15 . It also has a high morbidity, as declines are directly related to decreased mobility and ability to perform basic activities of daily living, raising fears of a new fall and thus favoring the loss of one's safety same. Thus the dependence on a caregiver or institutionalization in a home increases, in turn, the family, social and economic impact.

Falls in the elderly, unlike the adult, are the result of the adaptive imbalance of the person from the environment. The clinician relativizes this problem by attributing the fall to the normal aging process and ignore its potential consequences: injury, disability, institutionalization and even death in this population. For this reason, falls are considered a factor of frailty in the elderly .

The performance of health workers to a fall in the elderly patient should consist of the realization of the following measures :

  • Conduct a comprehensive assessment of elderly: biomedical, functional, social, mental and psycho-sphere.
  • Identify intrinsic, extrinsic risk factors and circumstances of the fall.
  • Estimate early physical, psychological and socio-economic consequences.
  • Prevention of falls at primary, secondary and tertiary levels. Frailty is a pathophysiological syndrome characterized by decreased functional reserve which is mainly linked to the loss of muscle mass or sarcopenia. This is caused by the decline in physical activity, associated in turn with poor health habits, cardiovascular risk factors and various chronic diseases. The consequences in the elderly affect multiple systems , causing greater vulnerability to external agents and increasing the risk: disability, hospitalization, institutionalization and death . The prevalence of frailty in subjects over 65 years is between 7 and 16.3% , increasing every decade from this age .

The diagnostic criteria for fragility, described by Linda Fried, include the assessment of functional aspects as the gait assessment, exhaustion or strength of palmar pressure with weight loss and energy consumption associated with physical activity . Since therapeutic perspective, one of the best ways to reverse the frailty is the physical exercise. Several articles have described heterogeneous effects on physical interventions in elderly frailty people , ranging from isolated programs of aerobic, anaerobic or balance to different combinations of the same training. A multicomponent exercise program increased muscle strength, improve cardiorespiratory fitness and balance11. Exercise programs have observed improvement in symptoms of depression in elderly patients10 up to 3 months after completion of the program . This benefit may be due to increased central monoamine activity and increased secretion of beta-endorphin. Similarly, it has been linked exercise programs with improvement in various cognitive domains, especially in executive functions. A 2003 meta-analysis indicates that the combined program of aerobic and anaerobic exercise have a better outcome on cognitive status than those designed with only aerobic programs.

STUDY JUSTIFICATION Nearly six million Spanish people are older than 70 years, 12.64% of the Spanish population is elderly. The first study in Spain on falls in the elderly was conducted in 1985 and from then until now, it has encouraged the investigation.

Practice guidelines in caring for the geriatric population recommend performing an annual screening of falls . Moreover, they suggest to advice the elderly on possible risk factors associated. However, one of the problems that interfere with fall prevention programs is the lack of importance accorded to health professionals to falls. This lack of awareness of the risks faced by the associated geriatric population falls generates reluctance to adherence to a fall prevention program .

At European level there are the same gaps in knowledge about the real effectiveness and efficiency of fall prevention programs .

Add the practice of physical activity in nursing interventions, under the environment of the community, have shown a reduction in the use of emergency services at relatively short intervals, probably due to improved continuity of care .

The Hunter study showed that a training program low-level resistance (twice a week) is associated with a decrease in the progression of functional limitations within 6 months.

Physical activity associated with an interdisciplinary approach improves overall assessment of the frail elderly population on the functional, psychological, cognitive, clinical and social part , , , .

It is necessary to create an interdisciplinary team in daily clinical practice in frail patients to perform adequately the full recognition of these patients with the following characteristics:

  • Shared management between nursing and primary care.
  • Support staff (nurses, social workers) with specialized training in gerontology.
  • Audit of the home and technical devices needs.
  • Regular team meetings to evaluate changes.
  • Establishment of communication with community resources to incremental improvements in the home, health promotion and support to caregivers.

HYPOTHESIS The implementation of a multicomponent fall prevention program in frail and pre-frail elderly community-dwelling people reduce the incidence of falls.

OBJECTIVES

General:

  • To determine the efficacy of a comprehensive program to prevent falls in the community.

Specific:

  • Knowing whether reducing the incidence of falls implies a reduction in visits to primary care, emergency department or hospital staying.
  • Knowing the adhesion, through indirect measures, to the intervention program.
  • Knowing the nutritional, functional, cognitive, social, anthropometric, respiratory and clinical profile, including falls, of the sample.

MATERIAL AND METHODS

Study design:

Multicenter community intervention study, longitudinal, prospective, randomized, and experimental.

Through intervention by nurses in primary care education of subjects over 70 years it is to know the effectiveness of a comprehensive program of falls prevention.

Being tested
Multicomponent physical activity
Keywords
Geriatric Assessment, Physical Education and Training

What participants receive

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

  • Multicomponent physical activityOther

    Balance, muscle strength and aerobic capacity will be increased in intensity according Training Intervention in a Controlled Population of Frail Elderly (EMTIFE) study NCT02331459

Study groups in NCT02631330
Study groupRoleWhat they receive
Falls prevention groupExperimentalIntervention group that will receive a monthly talk (individual or collective) of 30 minutes on the advantages of having a free fall hazards environment and multiple physical exercise component: balance,muscle strength and aerobic capacity and risk polypharmacy and abuse of drugs, especially benzodiazepines). In the same monthly meeting, subjects will be train "Multicomponent physical activity" program during 60 minutes. 15 minutes of gait and balance training; 15 minutes of endurance training; 30 minutes of aerobic training according Training Intervention in a Controlled Population of Frail Elderly (EMTIFE) study NCT02331459
Receives: Other: Multicomponent physical activity
Control groupNo interventionSubjects will receive the same information provided at the beginning to Falls prevention group. They will not receive further information during the follow-up period.

What is being measured

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

  1. Falls incidence change

    Number of falls observed during the follow up period

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

Secondary outcomes (10)
  1. Primary care and emergency department visits related with falls

    Number of visits related with falls observed during the follow up period in primary attention services, emergency departments and hospital admissions

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  2. Changes in nutritional status

    Change in nutritional parameters (MNA score) between groups during follow up period

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  3. Changes in functional status

    Changes in the following variable during follow up period: SHORT PHYSICAL PERFORMANCE BATTERY,

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  4. Changes in cognitive status

    Changes in the following variable during follow up period: MMSE

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  5. Changes in anthropometric measures

    Changes in the following variable during follow up period: BMI

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  6. Changes in respiratory function

    Changes in the following variables during follow up period

    : FVC, FEV1, FEV1/FVC, MEF25/75, FEV25, FEV50, FEV75, PEF, MIP (Maximal inspiratory pressure) (ELKA-PM15)®, MEP (Maximal espiratory pressure) (ELKA-PM15)®

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  7. Changes in daily living autonomy

    Changes in the following variables during follow up period

    : BARTHEL SCALE LAWTON SCALE

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  8. Changes in quality of life

    Changes in the following variables during follow up period

    :EUROQOL-5D

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  9. Changes in mood state

    Changes in the following variable during follow up period

    :Yesavage Geriatric Depression Scale.

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

  10. Changes in clinical aspects

    Changes in the following variable during follow up period

    : Hospital admissions rate related with falls

    Measured: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)

Timeline

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

  1. First posted16 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionJul 2017 (estimated)

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
466 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02631330
Sponsor's protocol ID
FAREMAVA2015
Acronym
FAREMAVA
Status last verified
Dec 2015
First submitted
3 Dec 2015
Last updated
16 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.

    PubMed 23327448
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156
  • Porter Starr KN, McDonald SR, Bales CW. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials. J Am Med Dir Assoc. 2014 Apr;15(4):240-50. doi: 10.1016/j.jamda.2013.11.008. Epub 2014 Jan 17.

    PubMed 24445063
  • Vivrette RL, Rubenstein LZ, Martin JL, Josephson KR, Kramer BJ. Development of a fall-risk self-assessment for community-dwelling seniors. J Aging Phys Act. 2011 Jan;19(1):16-29. doi: 10.1123/japa.19.1.16.

    PubMed 21285473
  • Theou O, Stathokostas L, Roland KP, Jakobi JM, Patterson C, Vandervoort AA, Jones GR. The effectiveness of exercise interventions for the management of frailty: a systematic review. J Aging Res. 2011 Apr 4;2011:569194. doi: 10.4061/2011/569194.

    PubMed 21584244

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Multicomponent physical activity in people with Accidental Falls, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Dec 2015. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Francisco J Tarazona-Santabalbina, MD,PhD (962458100 ext. 8387, fjtarazona@hospital-ribera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Falls incidence change (time frame: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)). 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 NCT02631330, which also lists 5 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 16 Dec 2015.

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