Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age

July 2, 2010 updated by: Cardenal Herrera University
The purpose of this study is to determine whether neuromuscular electrical stimulation, strengthening exercises, or combination of both over lower limbs are effective in the improvement of the stability fundamentally against falls, greater independence and, therefore, better quality of life in elderly over 75 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Moncada, Valencia, Spain, 46113
        • CEU-Cardenal Herrera University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age above 75

Exclusion Criteria:

  • Mental disorder
  • Previous electrotherapy treatments
  • Pacemakers
  • Lower limbs prosthetics
  • Major coronary diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Other: No intervention
Daily life activities
Experimental: Strengthening exercise
Strong progressive strengthening exercises of lower limbs.
Other: Strong progressive strengthening exercises of lower limbs
Lower limb weight
Experimental: Electrotherapy
Neuromuscular Electrical Nerve Stimulation
Other: Electrotherapy
Neuromuscular Electrical Nerve Stimulation
Experimental: Electrotherapy+weights
Other: Electrotherapy+weights
Superimposed Neuromuscular Electric Nerve Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: 3 months
Berg's Scale, SF-36 test, 6 minute walking test, Barthel test, SPPB.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength in lower limbs
Time Frame: 3 months
Dinamometry, bioimpedancy.
3 months
Timed standing balance. Side by side, semi tandem, tandem stand and one-leg stand
Time Frame: 3 months
Berg Scale, SPPB.
3 months
Maximum Gait Speed. Time to cover a 4 meter distance
Time Frame: 3 months
Physical performance test
3 months
Body mass index
Time Frame: 3 months
Bioimpedancy, ecography, lower limb perimeter.
3 months
Six-minute walking test
Time Frame: 3 months
Physical performance test, assessing maximum distance covered during 6 minutes (assistance allowed if required).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Investigators

  • Study Director: Javier Romero, Dean, Facultad Ciencias Salud CEU-UCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

July 5, 2010

Last Update Submitted That Met QC Criteria

July 2, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEU-UCH-87

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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