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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02138968
Other study ID # 17/13
Secondary ID CEIC 17/13
Status Completed
Phase N/A
First received May 12, 2014
Last updated August 31, 2015
Start date September 2013

Study information

Verified date August 2015
Source Consorci Sanitari del Maresme
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- More than 70 years consulting in primary care

- Non institutionalized

- Pre-frailty according to L.Fried criteria (1 or 2 criteria)

- Signed informed consent

Exclusion Criteria:

- Patient not able to stand by himself/herself

- Dementia

- Palliative care or life expectancy less than 6 months

- Blind patient

- unstable clinical situation

- Participation in other programs, studies or trials for elderly people

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Multidisciplinary intervention
Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.

Locations

Country Name City State
Spain Consorci Sanitari del Maresme Mataró Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari del Maresme

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Pain according Visual Analog Scale. One year No
Primary Frailty according to L.Fried criteria (questionnaire). L.Fried frailty criteria: (Robust: 0 criteria; Pre-frail: 1-2 criteria; Frail: >=3 criteria)
Weight loss
Fatigue
Poor physical activity
Low walking speed
Low muscle strength Reference of L.Fried: J Gerontol A Biol Sci Med Sci. 2001 Mar; 56(3):M146-56. PMID: 11253156.
One year No
Primary Functional capacity according to Barthel score and Timed up and go test. Barthel score and Timed up and go test. One year No
Secondary Nutritional status according to MNA-sf. Mini Nutritional Assessment short form (MNA-sf). One year No
Secondary Quality of live according to EuroQoL. EuroQoL. One year No
Secondary Mortality One year No
Secondary Health resource consumption (composite measure) Number of visits to primary care center, number of visits to hospital emergency department, number of hospitalizations, days of hospital stay, institutionalization to nursing homes, visits to nutritionist and visits to social services. One year No
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