search
Back to results

Central and Peripheral Fatigue in Individuals With Parkinson's Disease - Evaluation and Training

Primary Purpose

Parkinson Disease(PD)

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

About this trial

This is an interventional treatment trial for Parkinson Disease(PD) focused on measuring Muscle strength, fatigue, electromyography (EMG), central fatigue, strength straining

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Health subjects:

Exclusion Criteria:

  • Musculoskeletal injuries for knee.
  • Osteoporosis.
  • Diabetes.

PD subjects:

Inclusion Criteria:

  • Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

  • Musculoskeletal injuries for knee.
  • Osteoporosis.
  • Diabetes.
  • Any peripheral or central nervous system injury or disease patients.

Sites / Locations

  • Chang Gung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

No Intervention

No Intervention

No Intervention

Experimental

No Intervention

Arm Label

Stage 1: Health control

Stage 1: PD subjects

Stage 2: Health subjects

Stage 2: PD subjects

Stage 3: PD subjects

Stage 3: PD subjects (Control Subjects)

Arm Description

pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups.

pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups.

pilot study: Finding optimal sensory stimulation parameters for PD individuals.

pilot study: Finding optimal sensory stimulation parameters for PD individuals.

Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals.

Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals.

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

Secondary Outcome Measures

Full Information

First Posted
October 18, 2013
Last Updated
April 23, 2014
Sponsor
Chang Gung University
search

1. Study Identification

Unique Protocol Identification Number
NCT01971528
Brief Title
Central and Peripheral Fatigue in Individuals With Parkinson's Disease - Evaluation and Training
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)

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
Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past research indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Finding the contributions of the central and the peripheral factors to fatigue and developing an effective training program for individuals with PD are very important. 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. Quantifying the weighting of central versus peripheral factors contributing to the fatigue in people with PD is important. Most of the conventional strength and endurance training programs were based on the researches of young groups. Almost no training program was design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation is very important for individuals with PD who prone to fatigue. 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. Combining afferent input with strength training was more effective than strength training along. ES, which is easy to quantify the dose of afferent input, is a feasible method to provide such training. The purpose of this project is to investigate the effects of the combination of ES at sensory threshold and strength training on voluntary activation in the individuals with PD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease(PD)
Keywords
Muscle strength, fatigue, electromyography (EMG), central fatigue, strength straining

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1: Health control
Arm Type
No Intervention
Arm Description
pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups.
Arm Title
Stage 1: PD subjects
Arm Type
No Intervention
Arm Description
pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups.
Arm Title
Stage 2: Health subjects
Arm Type
No Intervention
Arm Description
pilot study: Finding optimal sensory stimulation parameters for PD individuals.
Arm Title
Stage 2: PD subjects
Arm Type
No Intervention
Arm Description
pilot study: Finding optimal sensory stimulation parameters for PD individuals.
Arm Title
Stage 3: PD subjects
Arm Type
Experimental
Arm Description
Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals.
Arm Title
Stage 3: PD subjects (Control Subjects)
Arm Type
No Intervention
Arm Description
Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals.
Intervention Type
Device
Intervention Name(s)
Electronic muscle stimulator
Intervention Description
Participants will perform 8 weeks of electrical stimulation for Quadriceps muscle belly(30 minutes/time, 3 times/week).
Intervention Type
Other
Intervention Name(s)
Muscle strength training
Intervention Description
Participants will perform 8 weeks of isotonic contraction muscle strength training for lower extremities.
Primary Outcome Measure Information:
Title
Muscle twitch force
Description
Measure of changes in muscle twitch force by interpolation twitch technique.
Time Frame
baseline, 8 weeks.
Title
Muscle voluntary activity level
Description
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
Time Frame
Baseline,8 weeks
Title
Muscle strength test for lower extremities.
Description
Measure of changes in muscle strength test by clinical test.
Time Frame
Baseline, 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,8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Health subjects: Exclusion Criteria: Musculoskeletal injuries for knee. Osteoporosis. Diabetes. PD subjects: Inclusion Criteria: Clinical diagnosis of Parkinson disease. Exclusion Criteria: Musculoskeletal injuries for knee. Osteoporosis. Diabetes. Any peripheral or central nervous system injury or disease patients.
Facility Information:
Facility Name
Chang Gung University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya-Ju Chang, PhD
Phone
88632118800
Ext
5515
Email
yjchang@mail.cgu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Central and Peripheral Fatigue in Individuals With Parkinson's Disease - Evaluation and Training

We'll reach out to this number within 24 hrs