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NCT01086592 Clinical Trial

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

Muscle Strength Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01086592
Other study ID # CEU-UCH-87
Secondary ID
Status Completed
Phase Phase 0
First received March 9, 2010
Last updated July 2, 2010
Start date February 2010
Est. completion date June 2010

Study information
Verified date June 2010
Source Cardenal Herrera University
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 118
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 75 Years and older
Eligibility Inclusion Criteria:

- Age above 75

Exclusion Criteria:

- Mental disorder

- Previous electrotherapy treatments

- Pacemakers

- Lower limbs prosthetics

- Major coronary diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
Daily life activities
• Strong progressive strengthening exercises of lower limbs
Lower limb weight
• Electrotherapy
Neuromuscular Electrical Nerve Stimulation
• Electrotherapy+weights
Superimposed Neuromuscular Electric Nerve Stimulation

Locations
Country Name City State
Spain CEU-Cardenal Herrera University Moncada Valencia

Sponsors (1)
Lead Sponsor Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. Review. — View Citation

Bax L, Staes F, Verhagen A. Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials. Sports Med. 2005;35(3):191-212. Review. — View Citation

Caggiano E, Emrey T, Shirley S, Craik RL. Effects of electrical stimulation or voluntary contraction for strengthening the quadriceps femoris muscles in an aged male population. J Orthop Sports Phys Ther. 1994 Jul;20(1):22-8. — View Citation

Hunter GR, McCarthy JP, Bamman MM. Effects of resistance training on older adults. Sports Med. 2004;34(5):329-48. Review. — View Citation

Paillard T, Noé F, Passelergue P, Dupui P. Electrical stimulation superimposed onto voluntary muscular contraction. Sports Med. 2005;35(11):951-66. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Functional Capacity Berg's Scale, SF-36 test, 6 minute walking test, Barthel test, SPPB. 3 months No
Secondary Strength in lower limbs Dinamometry, bioimpedancy. 3 months No
Secondary Timed standing balance. Side by side, semi tandem, tandem stand and one-leg stand Berg Scale, SPPB. 3 months No
Secondary Maximum Gait Speed. Time to cover a 4 meter distance Physical performance test 3 months No
Secondary Body mass index Bioimpedancy, ecography, lower limb perimeter. 3 months No
Secondary Six-minute walking test Physical performance test, assessing maximum distance covered during 6 minutes (assistance allowed if required). 3 months No
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