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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00059436
Other study ID # 1R01HD036725
Secondary ID
Status Completed
Phase Phase 1
First received April 25, 2003
Last updated September 23, 2016
Start date October 1999

Study information

Verified date May 2011
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of mental effort on improving muscle strength.


Description:

Training that involves heavy loads or resistance strengthens muscles. Recent data suggest that substantial voluntary strength gains can be achieved with training involving low resistance and strong mental effort. In contrast, individuals who train with the same low intensity contractions but with low mental effort show no improvement in strength.

This study will evaluate the relationship between mental effort muscle strength improvements by comparing the improvement in muscle strength in participants who have trained with different levels of mental effort. In addition to evaluating muscle strength, this study will also examine the neural mechanisms underlying muscle strength improvements.

Four groups of volunteers (65 years old and over) will participate in a training program directed at elbow-flexor muscles. One group will be trained with an intensity near the level of maximal voluntary contraction (MVC group); a second group will be trained with high mental effort, low muscle intensity contractions (HME group); a third group will be trained with low mental effort, low muscle intensity elbow-flexion contractions (LME group); and the fourth (control) group will not be trained but will participate in the strength tests. Training will be performed every weekday for 12 weeks. Participants will be evaluated by functional MRI (fMRI), EEG-derived motor activity-related cortical potential (MRCP), surface EMG signals, and the MRI T2 relaxation time.

Preliminary analysis of results shows that the HME group gained more than 13% strength, the LME group showed a statistically insignificant 6% change, and the no-practice control group did not show any change in elbow flexor muscle strength. We expect the MVC group to have the highest strength gains among the four groups.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date September 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria

- Healthy individuals free of neurological impairment

Exclusion Criteria

- Already involved in regular physical training

- Neuromuscular disorders

- Medications known to affect neuromuscular system (other than moderate alcohol or caffeine)

- Left-hand dominant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Mental effort in muscle strengthening


Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

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