NCT01971528

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2015

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

October 18, 2013

Last Update Submit

March 26, 2024

Conditions

Keywords

Muscle strength, fatigue, electromyography (EMG), central fatigue, strength straining

Outcome Measures

Primary Outcomes (4)

  • Muscle twitch force

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

    baseline, 8 weeks.

  • Muscle voluntary activity level

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

    Baseline,8 weeks

  • Muscle strength test for lower extremities.

    Measure of changes in muscle strength test by clinical test.

    Baseline, 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,8 weeks

Study Arms (6)

Stage 1: Health control

NO INTERVENTION

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

Stage 1: PD subjects

NO INTERVENTION

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

Stage 2: Health subjects

NO INTERVENTION

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

Stage 2: PD subjects

NO INTERVENTION

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

Stage 3: PD subjects

EXPERIMENTAL

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

Device: Electronic muscle stimulatorOther: Muscle strength training

Stage 3: PD subjects (Control Subjects)

NO INTERVENTION

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

Interventions

Participants will perform 8 weeks of electrical stimulation for Quadriceps muscle belly(30 minutes/time, 3 times/week).

Stage 3: PD subjects

Participants will perform 8 weeks of isotonic contraction muscle strength training for lower extremities.

Stage 3: PD subjects

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Musculoskeletal injuries for knee.
  • Osteoporosis.
  • Diabetes.
  • PD subjects:
  • Clinical diagnosis of Parkinson disease.
  • Musculoskeletal injuries for knee.
  • Osteoporosis.
  • Diabetes.
  • Any peripheral or central nervous system injury or disease patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Parkinson DiseaseFatigue

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 29, 2013

Study Start

December 18, 2012

Primary Completion

September 11, 2014

Study Completion

May 10, 2015

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations