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

March 26, 2024 updated by: Ya-Ju Chang, Chang Gung University

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

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taoyuan, Taiwan, 333
        • Chang Gung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2012

Primary Completion (Actual)

September 11, 2014

Study Completion (Actual)

May 10, 2015

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimated)

October 29, 2013

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

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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