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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01086592
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : July 5, 2010
Sponsor:
Information provided by:
Cardenal Herrera University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Geriatric Assessment Muscle Strength Postural Balance Body Mass Index Other: No intervention Other: Strong progressive strengthening exercises of lower limbs Other: Electrotherapy Other: Electrotherapy+weights Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age
Study Start Date : February 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Functional Capacity [ Time Frame: 3 months ]
    Berg's Scale, SF-36 test, 6 minute walking test, Barthel test, SPPB.


Secondary Outcome Measures :
  1. Strength in lower limbs [ Time Frame: 3 months ]
    Dinamometry, bioimpedancy.

  2. Timed standing balance. Side by side, semi tandem, tandem stand and one-leg stand [ Time Frame: 3 months ]
    Berg Scale, SPPB.

  3. Maximum Gait Speed. Time to cover a 4 meter distance [ Time Frame: 3 months ]
    Physical performance test

  4. Body mass index [ Time Frame: 3 months ]
    Bioimpedancy, ecography, lower limb perimeter.

  5. Six-minute walking test [ Time Frame: 3 months ]
    Physical performance test, assessing maximum distance covered during 6 minutes (assistance allowed if required).


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age above 75

Exclusion Criteria:

  • Mental disorder
  • Previous electrotherapy treatments
  • Pacemakers
  • Lower limbs prosthetics
  • Major coronary diseases
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086592


Locations
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Spain
CEU-Cardenal Herrera University
Moncada, Valencia, Spain, 46113
Sponsors and Collaborators
Cardenal Herrera University
Investigators
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Study Director: Javier Romero, Dean Facultad Ciencias Salud CEU-UCH
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pedro Rosado Calatayud/Physical Therapy Coordinator, CEU-Cardenal Herrera
ClinicalTrials.gov Identifier: NCT01086592    
Other Study ID Numbers: CEU-UCH-87
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: July 5, 2010
Last Verified: June 2010
Keywords provided by Cardenal Herrera University:
Aged
Strength
Balance
Electrotherapy
Quality of life