NCT02122653

Brief Summary

Muscle strength and endurance are important indexes of fitness. The muscle strength is the most important single predict factor of functional ability in aged frail individuals. Frailty related muscle weakness and fatigue are adapted from the pre-frail stage. Finding the contributions of the central and the peripheral factors to the deficits of muscle fitness and developing an effective muscle fitness training program for pre-frail individuals are very important. The muscle weakness and fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Studies found the selective type II fiber atrophy in aged people and this finding was different from the type I atrophy in conventional immobilization models. It is possible that the activation failure leads to the recruitment failure of high threshold type II fibers at the pre-frail stage. Quantifying the weighting of central versus peripheral factors contributing to the exercise limitation in pre-frail people is important. Most of the conventional strength and endurance training programs are based on the researches of young groups. These programs are not able to prevent people become frail. It is possibly that, due to the limitation of central fatigue, the pre-frail individuals stop exercise before the effective intensity being achieved. Almost no training program has been design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation at the pre-frail stage is very important for preventing people become frail. Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. ES, which is easy to quantify the dose of afferent input, is a feasible method to be used in training. Combining afferent input with strength training might be able to overcome the central activation failure and help recruit high threshold motor unit in pre-frail individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

April 23, 2014

Last Update Submit

April 23, 2014

Conditions

Keywords

Fatigueagingtranscranial magnetic stimulationinterpolatedtwitch technique

Outcome Measures

Primary Outcomes (4)

  • Muscle twitch force

    Measure of changes in muscle twitch force by interpolation twitch technique.

    Baseline, 4 weeks,8 weeks.

  • Muscle voluntary activity level

    Measure of changes in muscle voluntary activity level by interpolation twitch technique.

    Baseline, 4 weeks,8 weeks.

  • The central activation and the excitability of motor cortex

    Measure of changes in the central activation and the excitability of motor cortex by Transcranial magnetic stimulation.

    Baseline, 4 weeks,8 weeks.

  • Muscle strength test for lower extremities.

    Measure of changes in muscle strength test for lower extremities by clinical test.

    Baseline, 4 weeks,8 weeks.

Study Arms (3)

Older WT

EXPERIMENTAL

Older people with weight training

Other: Weight training

Older WT and ES

EXPERIMENTAL

Older people with weight training combined electrical stimulation.

Other: Weight trainingDevice: Electronic muscle stimulator

Young control group

NO INTERVENTION

Young people with control group

Interventions

Participants will perform 4 weeks of Weight training for lower extremities.

Older WTOlder WT and ES

Participants will perform 4 weeks of electrical stimulation for Quadriceps muscle belly.

Older WT and ES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Musculoskeletal injuries for knee. Osteoporosis. Diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 24, 2014

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations