Effectiveness of a Multifactorial Intervention on Frailty

Cognitive Impairment Clinical Trial

Official title:

Effectiveness of a Multifactorial Intervention to Modify Frailty Parameters in Elderly Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969526
• Other study ID #: PI12/01503
• Status: Completed
• Phase: N/A
• First received: August 1, 2013
• Last updated: November 8, 2017
• Start date: January 2013
• Est. completion date: September 30, 2017

Study information

• Verified date: March 2017
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To evaluate the effectiveness of a multifactorial intervention program based on physical activity and diet, memory workshops and review of medication, to modify frailty parameters, muscle strength and physical and cognitive performance in people 65 years or older with a positive screening for frailty. Secondly, to assess changes in falls, hospitalizations, nutritional risk, disability and institutionalization or home-care.

Methods: randomized clinical trial with a control group, of one year and a half of follow-up, conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years or older with positive frailty screening, timed get-up-and-go between 10 to 30 seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will be selected in each group (difference to be detected on physical performance (Short physical performance battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).

Intervention: consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.

Evaluations will be blinded and conducted at 0, 3 and 18 months. Analysis of variance for repeated measures to adjust for differences attributable to intervention effect and for potential confounders such as comorbidity, sensory limitations, social risk, other medical or social interventions, among others.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: September 30, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Positive Barber screen

• Timed get-up-and-go 10 to 20 seconds

• cognitive Lobo test greater than or equal to 18

Exclusion Criteria:

• Home Care

• Institutionalization

• Conditions not allowing physical exercise

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dependence
• Frail Elderly

Intervention

Other:
• Multifactorial intervention
Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy and physical exercise plus intake of hyperproteic shakes, memory workshop and review of the medication.

Locations

Country	Name	City	State
Spain	Institut Català de la Salut	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Romera L, Orfila F, Segura JM, Ramirez A, Möller M, Fabra ML, Lancho S, Bastida N, Foz G, Fabregat MA, Martí N, Cullell M, Martinez D, Giné M, Bistuer A, Cendrós P, Pérez E. Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design. BMC Geriatr. 2014 Nov 27;14:125. doi: 10.1186/1471-2318-14-125. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Short Physical performance battery at 3 and 18 months	The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).	0,3,18 months
Primary	Change from Baseline in Muscle strength at 3 and 18 months	Evaluation of upper extremities strength was assessed through the measurement of force with a handgrip dynamometer. Grip strength was evaluated using a portable hand dynamometer (JAMAR®0-90 kg, coding 506320). The participants were seated with their shoulder in a neutral position and their elbow flexed at 90°. Three attempts were performed alternately in each hand; the mean of the three measures was recorded.	0,3,18 months
Primary	Change from Baseline in Cognitive Performance (Barcelona test) at 3 and 18 months	The first neuro-psychometric instrument developed in Spain to measure semi-quantitatively cognitive status in clinical neurology was the Barcelona Test (BT). Shortened version of the BT, named Barcelona Test Review (BTR) had been used for neuropsychological area evaluation in our participants and it takes only 20-30 minutes to administer	0,3,18 months
Secondary	Number of Participants with Falls during follow-up, at 18 months		18 months
Secondary	Change from Baseline in Functional Capacity at 18 months	Barthel Index Lawton&Brody Index	18 months
Secondary	Number of Participants Hospitalized during follow-up, at 18 months		18 months
Secondary	Number of Participants Institutionalized during follow-up, at 18 months		18 months
Secondary	Number of Participants included in Home Health care during follow-up, at 18 months		18 months