Multicomponent Exercise Training in Frail Elderly

NCT ID: NCT03986840

Last Updated: 2020-01-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-12-25

Brief Summary

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The aim of the present study will be to assess the effectiveness of the multicomponent exercise training in frail for the physical function, frailty and performance.

All the individuals will be assessed two times.

Detailed Description

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This will be a experimental, randomized controlled intervention study in frail. Subjects will be recruited at the Albertia Care Center, Madrid. The exercise training group will developed a concurrent training 3 days per week during 6 weeks. The control group will follow an usual care also for 6 weeks.

The main variables will be as follows:

* Ultrasound imaging measurements for the lower limb: core muscles, vastus medialis, rectus femoris, vastus intermedius, gastrocnemius, soleus. We will employed a General Electric (GE) Ultrasound device in B mode to assess the thickness of the muscles.
* Heart rate variability with a Suunto smart bell.
* Activities of daily living with the Bartel index.
* Force-velocity profile and muscle power.
* Frailty with the Linda´s frailty criteria.

The exercise program was applied for 6 weeks. A total of 18 sessions were distributed in 3 weekly sessions. The participants performed a resistance exercises: leg press at an intensity of 40%-60% with 10 repetitions, 12 repetitions of steps with their bodyweight and a plantar flexion followed by a cardiovascular high intensity interval training (HIIT) exercise walking on a treadmill.

One measurements will be taken (pre), the second (post) measurements will be performed at 6 weeks.

Conditions

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Frailty Exercise Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise program

The exercise program was applied for 6 weeks. A total of 18 sessions were distributed in 3 weekly sessions. The participants performed a resistance exercises: leg press at an intensity of 40%-60% with 10 repetitions, 12 repetitions of steps with their bodyweight and a plantar flexion followed by a cardiovascular HIIT exercise walking on a treadmill.

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

A multicomponent exercise program

Daily activities

The patients who belongs to this group will continue to perform their daily routines.

Group Type ACTIVE_COMPARATOR

Exercise training

Intervention Type OTHER

A multicomponent exercise program

Interventions

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Exercise training

A multicomponent exercise program

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 75 years or more,
* 2 or more points in the Short Physical Performance Battery (SPPB)
* Capability of walking (alone or assisted)

Exclusion Criteria

* Severity cognitive alterations
* Severe disability on the Barthel score
* Surgeries in the previous 6 months
* Other any disorder that exclude for the exercise group.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Carlos Romero Morales

Senior Lecturer, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergio López, MsC

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

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Albertia Elderly Care Center

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CIPI/

Identifier Type: -

Identifier Source: org_study_id

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