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Effectiveness of a Multifactorial Intervention on Frailty

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ClinicalTrials.gov Identifier: NCT01969526
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Frail Elderly Cognitive Impairment Dependence Other: Multifactorial intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of a Multifactorial Intervention to Modify Frailty Parameters in Elderly Population
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : September 30, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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 plus intake of hyperproteic shakes, memory workshop and review of the medication.
 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.
Other Name: Multifactorial intervention on frailty dimensions
No Intervention: No intervention
Usual care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969526


Locations
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Spain
Institut Català de la Salut
Barcelona, Spain
Sponsors and Collaborators
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Carlos III Health Institute
Investigators
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Principal Investigator: Josep Maria segura, MD, Phd Jordi Gol Foundation
More Information
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Publications:

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Responsible Party: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
ClinicalTrials.gov Identifier: NCT01969526    
Other Study ID Numbers: PI12/01503
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: March 2017
Keywords provided by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina:
Frail elderly
Additional relevant MeSH terms:
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Frailty
Pathologic Processes