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

NCT02631330 | Unknown Phase 3 DMC

• 1 other identifier: FAREMAVA2015
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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) .

Conditions

Accidental Falls

Keywords

Geriatric Assessment; Physical Education and Training

Outcome Measures

Primary Outcomes (1)

• Falls incidence change

  Number of falls observed during the follow up period

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

Secondary Outcomes (10)

• Primary care and emergency department visits related with falls

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

• Changes in nutritional status

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

• Changes in functional status

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

• Changes in cognitive status

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

• Changes in anthropometric measures

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

Study Arms (2)

Falls prevention group

EXPERIMENTAL

Intervention 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

Other: Multicomponent physical activity

Control group

NO INTERVENTION

Subjects will receive the same information provided at the beginning to Falls prevention group. They will not receive further information during the follow-up period.

Interventions

Multicomponent physical activity OTHER

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

Falls prevention group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de la Ribera: lead

Study Sites (1)

Hospital Universitario de la Ribera

Alzira, Valéncia, 46600, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 23327448 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 24445063 BACKGROUND

• 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.

  PMID: 21285473 BACKGROUND

• 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.

  PMID: 21584244 BACKGROUND

Study Officials

• Francisco J Tarazona-Santabalbina, MD,PhD

  Hospital Universitario de la Ribera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco J Tarazona-Santabalbina, MD,PhD

CONTACT

962458100; fjtarazona@hospital-ribera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Consultant in Geriatric Medicine Hospital Universitario de la Ribera. Associated Professor Universidad Católica de Valencia San Vicente Mártir

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

ES (1)