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Evaluation and Training of Muscle Fitness in Pre-frail Individuals

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Weight training
Electronic muscle stimulator
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Fatigue, aging, transcranial magnetic stimulation, interpolated, twitch technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Health subjects:

Exclusion Criteria:

Musculoskeletal injuries for knee. Osteoporosis. Diabetes.

Sites / Locations

  • Chang Gung University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Older WT

Older WT and ES

Young control group

Arm Description

Older people with weight training

Older people with weight training combined electrical stimulation.

Young people with control group

Outcomes

Primary Outcome Measures

Muscle twitch force
Measure of changes in muscle twitch force by interpolation twitch technique.
Muscle voluntary activity level
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
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.
Muscle strength test for lower extremities.
Measure of changes in muscle strength test for lower extremities by clinical test.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2014
Last Updated
April 23, 2014
Sponsor
Chang Gung University
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1. Study Identification

Unique Protocol Identification Number
NCT02122653
Brief Title
Evaluation and Training of Muscle Fitness in Pre-frail Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Fatigue, aging, transcranial magnetic stimulation, interpolated, twitch technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Older WT
Arm Type
Experimental
Arm Description
Older people with weight training
Arm Title
Older WT and ES
Arm Type
Experimental
Arm Description
Older people with weight training combined electrical stimulation.
Arm Title
Young control group
Arm Type
No Intervention
Arm Description
Young people with control group
Intervention Type
Other
Intervention Name(s)
Weight training
Intervention Description
Participants will perform 4 weeks of Weight training for lower extremities.
Intervention Type
Device
Intervention Name(s)
Electronic muscle stimulator
Intervention Description
Participants will perform 4 weeks of electrical stimulation for Quadriceps muscle belly.
Primary Outcome Measure Information:
Title
Muscle twitch force
Description
Measure of changes in muscle twitch force by interpolation twitch technique.
Time Frame
Baseline, 4 weeks,8 weeks.
Title
Muscle voluntary activity level
Description
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
Time Frame
Baseline, 4 weeks,8 weeks.
Title
The central activation and the excitability of motor cortex
Description
Measure of changes in the central activation and the excitability of motor cortex by Transcranial magnetic stimulation.
Time Frame
Baseline, 4 weeks,8 weeks.
Title
Muscle strength test for lower extremities.
Description
Measure of changes in muscle strength test for lower extremities by clinical test.
Time Frame
Baseline, 4 weeks,8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Health subjects: Exclusion Criteria: Musculoskeletal injuries for knee. Osteoporosis. Diabetes.
Facility Information:
Facility Name
Chang Gung University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Evaluation and Training of Muscle Fitness in Pre-frail Individuals

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