NCT03657940

Brief Summary

Randomized Controlled trial of 370 aged participants over 75 years old coming from clinics of Geriatric Departments in three University Hospitals in Spain (Pamplona, Getafe y San Sebastián). Participants who met inclusion criteria will be randomized to control (usual care)l or intervention group (multicomponent exercise program). The main objective of the trial is to study the effect of a multicomponent exercise training program (resistance, aerobic, strength, balance and flexibility) in frail aged participants who live in the community with cognitive decline in: functional capacity, strength, power, cognition, falls , depression, quality of life, institutionalization and hospital admissions

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

July 30, 2018

Last Update Submit

September 3, 2018

Conditions

Frail Elderly SyndromeCognitive Impairment

Keywords

Exercise therapy

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery (SPPB)

    The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB) which evaluates, balance, gait ability, and leg strength using a single tool. The total score ranges from 0 (worst) to 12 points (best). The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization, and mortality. A total score of less than 10 indicates frailty and a high risk of disability and falls. A one-point change in the score has clinical relevance

    Changes from baseline to 1st and 3th months of follow up

Secondary Outcomes (25)

  • Barthel index

    Changes from baseline to 1st and 3th months of follow up

  • Handgrip strength in the dominant hand

    Changes from baseline to 1st and 3th months of follow up

  • 6-metre gait velocity test (GVT).

    Changes from baseline to 1st and 3th months of follow up

  • MEC-Lobo cognitive test

    Changes form baseline to 1st and 3th months of follow up

  • MOCA( Montreal Cognitive Assessment) test

    Changes from baseline to 1st and 3th months of follow up

  • +20 more secondary outcomes

Other Outcomes (13)

  • Mini- Nutritional Assessment (MNA)

    Baseline visit

  • Cumulative Illness Rating Scale for Geriatrics (CIRS-G)

    Baseline visit

  • Functional Activities Questionnaire (FAQ)

    Changes from baseline to 1st and 3th months follow up

  • +10 more other outcomes

Study Arms (2)

Exercise intervention

EXPERIMENTAL

multicomponent exercise training program \[VIVIFRAIL\],

Behavioral: VIVIFRAIL multicomponent exercise training program

Usual Care

NO INTERVENTION

Participants randomly assigned to the usual care group will receive normal outpatient care, which includes physical rehabilitation when needed.

Interventions

VIVIFRAIL multicomponent exercise training programBEHAVIORAL

The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1Repetition Maximum ( combined with balance-training, flexibility and gait exercises that progressed in difficulty.

Exercise intervention

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \- Age: 75 years or older.
  • Able to ambulate with or without personal/technical assistance.
  • Barthel Index ≥ 60.
  • Able to communicate.
  • Mild cognitive impairment or Dementia level GDS-4.
  • Fragility o pre-frailty according to Linda Fried ≥ 1.
  • Subjects should have someone to help them do the exercises.
  • Informed consent: Must be capable and willing to provide consent.

You may not qualify if:

  • Any factor precluding performance of the physical training programme or testing procedures as determined by the attending physician. These factors include, but are not limited to the following:
  • Myocardial infarction in the past 3 months.
  • Unstable Angina pectoris.
  • Terminal illness.
  • Uncontrolled arrhythmia.
  • Unstable cardiovascular disease or other medical condition.
  • Uncontrolled arterial hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Miguel Servet/ Navarrabiomed

Pamplona, 31008, Spain

RECRUITING

Related Publications (2)

  • Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.

    PMID: 35150086DERIVED

  • Casas-Herrero A, Anton-Rodrigo I, Zambom-Ferraresi F, Saez de Asteasu ML, Martinez-Velilla N, Elexpuru-Estomba J, Marin-Epelde I, Ramon-Espinoza F, Petidier-Torregrosa R, Sanchez-Sanchez JL, Ibanez B, Izquierdo M. Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial. Trials. 2019 Jun 17;20(1):362. doi: 10.1186/s13063-019-3426-0.

    PMID: 31208471DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Alvaro Casas Herrero, MD PhD

    Complejo Hospitalario de Navarra/Fundación Navarrabiomed

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro Casas Herrero, MD PhD

CONTACT

+(34) 848422287alvaro.casas.herrero@navarra.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

September 5, 2018

Study Start

September 1, 2017

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)