- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01971528
Central and Peripheral Fatigue in Individuals With Parkinson's Disease - Evaluation and Training
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taoyuan, Taiwan, 333
- Chang Gung University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Stage 1: Health control
pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups.
|
|
No Intervention: Stage 1: PD subjects
pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups.
|
|
No Intervention: Stage 2: Health subjects
pilot study: Finding optimal sensory stimulation parameters for PD individuals.
|
|
No Intervention: Stage 2: PD subjects
pilot study: Finding optimal sensory stimulation parameters for PD individuals.
|
|
Experimental: Stage 3: PD subjects
Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals.
|
Participants will perform 8 weeks of electrical stimulation for Quadriceps muscle belly(30 minutes/time, 3 times/week).
Participants will perform 8 weeks of isotonic contraction muscle strength training for lower extremities.
|
No Intervention: Stage 3: PD subjects (Control Subjects)
Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle twitch force
Time Frame: baseline, 8 weeks.
|
Measure of changes in muscle twitch force by interpolation twitch technique.
|
baseline, 8 weeks.
|
Muscle voluntary activity level
Time Frame: Baseline,8 weeks
|
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
|
Baseline,8 weeks
|
Muscle strength test for lower extremities.
Time Frame: Baseline, 8 weeks
|
Measure of changes in muscle strength test by clinical test.
|
Baseline, 8 weeks
|
The central activation and the excitability of motor cortex
Time Frame: Baseline,8 weeks
|
Measure of changes in the central activation and the excitability of motor cortex by Transcranial magnetic stimulation.
|
Baseline,8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100-3167A3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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