Establishing the Central and Peripheral Fatigue Indexes and VR Based Anti-fatigue Training Paradigm for Individuals With Parkinson Disease

NCT02017938 | Completed DMC

• 1 other identifier: 101-5141B
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past researches 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, building reliable fatigue indexes, and developing an effective training program for individuals with PD are very important. The purpose of this project is to develop non-invasive method to monitor central and peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training paradigm, and to evaluate the long term training effect in individuals with PD.

Conditions

Parkinson's Disease (PD)

Keywords

Fatigue; electromyography (EMG); central fatigue; cycling training

Outcome Measures

Primary Outcomes (4)

• Muscle twitch force

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

  baseline, 1 week

• Muscle voluntary activity level

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

  Baseline,1 week

• Heart rate/Heart rate variability

  Measure of changes in Heart rate/Heart rate variability.

  Baseline,1 week

• Borg's rate of perceived exertion

  Measure of changes in Borg's rate of perceived exertion.

  Baseline,1 week

Study Arms (5)

Stage 1: Health group

NO INTERVENTION

To establish non-invasive fatigue monitoring method via testing healthy individuals.

Stage 2: PD group

EXPERIMENTAL

To find the optimal feedback variables for anti-fatigue training on individuals with PD.

Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)

Stage 2: Health group

EXPERIMENTAL

Stage 2 controlled group

Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)

Stage 3: PD group

EXPERIMENTAL

To evaluate the effect of four weeks of VR anti-fatigue ergo cycling training on various fatigue components and functional abilities in individuals with PD.

Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)

Stage 3: PD controlled group

NO INTERVENTION

Stage 3 controlled group

Interventions

Virtual Reality anti-fatigue ergo cycling training (Self-made) PROCEDURE

To establish a Virtual Reality systems to reduce fatigue of cycling training for PD subjects.

Stage 2: Health group; Stage 2: PD group; Stage 3: PD group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Parkinson disease
• Hoehn and Yahr ≦3

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological 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: Profesor

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: December 10, 2014
• Primary Completion: July 30, 2015
• Study Completion: July 31, 2016
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

TW (1)