Clinical trial NCT03657940: Impact of a Multicomponent Exercise Program on Functional Capacity in Frail Aged Participants With Cognitive Decline
Official title: Impact of a Multicomponent Exercise Program (VIVIFRAIL)on Functional Capacity in Frail Community Aged Participants With Cognitive Decline . Multi-center Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Cognitive Impairment
Keywords: Exercise therapy
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Matia Foundation
name: Hospital Universitario Getafe
First posted: 2018-09-05
Enrollment: 240
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Usual care group (control) Participants randomly assigned to the usual care group will receive normal outpatient care, which includes physical rehabilitation when needed.

Intervention group (training) The intervention will consist of a multicomponent exercise training programme -VIVIFRAIL-(A Practical Guide for Prescribing a Multi-Component Physical Training Program to prevent weakness and falls in People over 70, Showed in www.vivifrail.com), which will be composed of supervised progressive resistance training, balance-training, flexibility and cardiovascular for 7 days/week. During the training period, patients will be trained between 2 and 120 minutes each day.

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 1RM combined with balance-training, flexibility and gait exercises that progressed in difficulty. The resistance exercises focused on the major upper and lower limb muscles. During the progressive resistance training, instruction will be provided to the participants to perform the exercises at a high velocity of motion. However, care will be taken to ensure that exercises were executed with correct form. Balance and gait training exercises that progressed in difficulty will be also implemented: e.g. semitandem foot standing, line walking, stepping practice, walking with small obstacles, proprioceptive exercises, and altering the base of support and weight transfer from one leg to the other. An experienced physical trainer will carefully explain all the exercises. Participants and their carer / family members will be carefully familiarized with the training procedures in advance.

Eligibility criteria: Inclusion Criteria:

* - 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Changes from baseline to 1st and 3th months of follow up
Secondary outcomes:
measure: Barthel index
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Handgrip strength in the dominant hand
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: 6-metre gait velocity test (GVT).
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: MEC-Lobo cognitive test
timeFrame: Changes form baseline to 1st and 3th months of follow up
measure: MOCA( Montreal Cognitive Assessment) test
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Trail Making Test part A ( TMT-A)
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Isometric lower limb strength test (right knee extensors and hip flexors)
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: 1Repetition Maximum (RM) Maximal dynamic strength test
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Repetitions at maximal velocity at intensities of 50% of 1RM test
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Geriatric Depression Scale ( GDS) Yesavage abbreviated scale
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Categorical pain scale
timeFrame: Changes from baseline to and 3th months of follow up
measure: Rate of falls
timeFrame: Baseline, 1st and 3th months of follow up
measure: Vivifrail risk of falls scale
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Mortality
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Admissions to the hospital
timeFrame: Baseline, 1st and 3th months of follow up
measure: Incidence of institutionalization to nursing homes
timeFrame: Baseline, 1st and 3th months of follow up
measure: Visit to emergency room
timeFrame: Baseline, 1st and 3th months of follow up
measure: Number of total Drugs
timeFrame: Changes from baseline to 3th month´s follow up
measure: Presence of 5 or more drugs ( Polypharmacy ) registration
timeFrame: Changes from baseline to 3th month´s follow up
measure: Psychotropic drugs (neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics) registration
timeFrame: Changes from baseline to 3th month´s follow up
measure: Neuropsychiatric Inventory Questionary (NPI)
timeFrame: Changes from baseline and 3th month´s follow up
measure: Dual task gait ( arithmetic) 6 m velocity test
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: Dual task gait (verbal) 6 m velocity test
timeFrame: Changes from baseline to 1st and 3th months of follow up
measure: EuroQol-5D (EQ-5D) quality of life assessment test
timeFrame: Changes from baseline to 3th month´s follow up
measure: Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )
timeFrame: Changes from baseline to 3th month´s follow up
Other outcomes:
measure: Mini- Nutritional Assessment (MNA)
timeFrame: Baseline visit
measure: Cumulative Illness Rating Scale for Geriatrics (CIRS-G)
timeFrame: Baseline visit
measure: Functional Activities Questionnaire (FAQ)
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Isaacs set test
timeFrame: Changes from baseline to 3th month´s follow up
measure: Gait regularity analysis with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Gait cadence analysis with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Gait variability analysis with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Gait symmetry analysis with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Five Times Sit to Stand peak power analysis test with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Five Times Sit to Stand impulse analysis test with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Five Times Sit to Stand orientation analysis test with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Balance power spectrum analysis test with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
measure: Balance area analysis test with an inertial sensor unit
timeFrame: Changes from baseline to 1st and 3th months follow up
Locations:
city: Pamplona
country: Spain
facility: Fundación Miguel Servet/ Navarrabiomed
Study officials:
affiliation: Complejo Hospitalario de Navarra/Fundación Navarrabiomed
name: Alvaro Casas Herrero, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.