Impact of a Multicomponent Exercise Program on Functional Capacity in Frail Aged Participants With Cognitive Decline

Fundacion Miguel Servet

Status

Unknown

Conditions

Cognitive Impairment

Frail Elderly Syndrome

Treatments

Behavioral: VIVIFRAIL multicomponent exercise training program

Study type

Interventional

Funder types

Other

Identifiers

NCT03657940

Gov NA 28-16

Details and patient eligibility

About

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

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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.