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

Sponsor
Cardenal Herrera University (Other)
Overall Status
Completed
CT.gov ID
NCT01086592
Collaborator
(none)
118
1
4
3.9
29.9

Study Details

Study Description

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
  • Other: No intervention
  • Other: Strong progressive strengthening exercises of lower limbs
  • Other: Electrotherapy
  • Other: Electrotherapy+weights
Early Phase 1

Study Design

Study Type:
Interventional
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 :
Feb 1, 2010
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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

Primary Outcome Measures

  1. Functional Capacity [3 months]

    Berg's Scale, SF-36 test, 6 minute walking test, Barthel test, SPPB.

Secondary Outcome Measures

  1. Strength in lower limbs [3 months]

    Dinamometry, bioimpedancy.

  2. Timed standing balance. Side by side, semi tandem, tandem stand and one-leg stand [3 months]

    Berg Scale, SPPB.

  3. Maximum Gait Speed. Time to cover a 4 meter distance [3 months]

    Physical performance test

  4. Body mass index [3 months]

    Bioimpedancy, ecography, lower limb perimeter.

  5. Six-minute walking test [3 months]

    Physical performance test, assessing maximum distance covered during 6 minutes (assistance allowed if required).

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age above 75
Exclusion Criteria:
  • Mental disorder

  • Previous electrotherapy treatments

  • Pacemakers

  • Lower limbs prosthetics

  • Major coronary diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01086592
Other Study ID Numbers:
  • CEU-UCH-87
First Posted:
Mar 15, 2010
Last Update Posted:
Jul 5, 2010
Last Verified:
Jun 1, 2010

Study Results

No Results Posted as of Jul 5, 2010