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

This study has been completed.
Sponsor:
Information provided by:
Cardenal Herrera University
ClinicalTrials.gov Identifier:
NCT01086592
First received: March 9, 2010
Last updated: July 2, 2010
Last verified: June 2010
  Purpose

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 Intervention 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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age

Resource links provided by NLM:


Further study details as provided by Cardenal Herrera University:

Primary Outcome Measures:
  • Functional Capacity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Berg's Scale, SF-36 test, 6 minute walking test, Barthel test, SPPB.


Secondary Outcome Measures:
  • Strength in lower limbs [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Dinamometry, bioimpedancy.

  • Timed standing balance. Side by side, semi tandem, tandem stand and one-leg stand [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Berg Scale, SPPB.

  • Maximum Gait Speed. Time to cover a 4 meter distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Physical performance test

  • Body mass index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Bioimpedancy, ecography, lower limb perimeter.

  • Six-minute walking test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Physical performance test, assessing maximum distance covered during 6 minutes (assistance allowed if required).


Enrollment: 118
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086592

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

Additional Information:
Publications:
Responsible Party: Pedro Rosado Calatayud/Physical Therapy Coordinator, CEU-Cardenal Herrera
ClinicalTrials.gov Identifier: NCT01086592     History of Changes
Other Study ID Numbers: CEU-UCH-87
Study First Received: March 9, 2010
Last Updated: July 2, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Cardenal Herrera University:
Aged
Strength
Balance
Electrotherapy
Quality of life

ClinicalTrials.gov processed this record on April 16, 2014