Skip to main content
OpenTrials
Completed

NCT Number: NCT01969526

Effectiveness of a Multifactorial Intervention on Frailty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Frail Elderly Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dependence Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Català de la Salut

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multifactorial intervention

Other

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.

Other names: Multifactorial intervention on frailty dimensions

Primary outcomes

  1. Change from Baseline in Short Physical performance battery at 3 and 18 months

    Time frame: 0,3,18 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).

  2. Change from Baseline in Muscle strength at 3 and 18 months

    Time frame: 0,3,18 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.

  3. Change from Baseline in Cognitive Performance (Barcelona test) at 3 and 18 months

    Time frame: 0,3,18 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

Secondary outcomes

  1. Number of Participants with Falls during follow-up, at 18 months

    Time frame: 18 months

  2. Change from Baseline in Functional Capacity at 18 months

    Time frame: 18 months

    Barthel Index Lawton&Brody Index

  3. Number of Participants Hospitalized during follow-up, at 18 months

    Time frame: 18 months

  4. Number of Participants Institutionalized during follow-up, at 18 months

    Time frame: 18 months

  5. Number of Participants included in Home Health care during follow-up, at 18 months

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 25, 2013
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.