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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Frail Elderly Syndrome Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise intervention

multicomponent exercise training program \[VIVIFRAIL\],

Group Type EXPERIMENTAL

VIVIFRAIL multicomponent exercise training program

Intervention Type BEHAVIORAL

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.

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VIVIFRAIL multicomponent exercise training program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No