The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease

The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease.

Study Overview

• Status: Completed
• Conditions: Safety and Effectiveness
• Intervention / Treatment: Other: Dual-task cognitive-cycling training

Detailed Description

Background: Parkinson's disease is a neurodegenerative disorder of the basal ganglia in which the production of dopamine is reduced, leading to the motor and non-motor impairment and the loss of automaticity. Recently, the results across studies have indicated that motor-cognitive dual-task deficits in individuals with neurologic disorders appear to be amenable to training. Improvement of dual-task ability in individuals with neurologic disorders holds potential for improving gait, balance, and cognition. The most recent European guideline provides a more graded view, stating that in Hoehn and Yahr stages 2 and 3 dual-task training may be safe and effective. An overview of current ongoing randomized controlled trials focusing on dual-task rehabilitation, gait training or treadmill training was the major motor-task. However, cycling augmented by cognitive training has not been evaluated. In addition, antioxidant capacity is unclear for Parkinson's disease patients with long-term, regular cycling training.

Study purpose: The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease. The antioxidant capacity will be assessed as well.

Methods: Parkinson's disease patients will be assigned to cycling training, cycling-cognitive dual task training, and following 8 weeks. All of the subjects will complete 3 assessments at pre-training, post-4 weeks, and post-8 weeks. The outcome measures are clinical severity and disability, performance of gait-cognitive and cycling-cognitive, cognitive-task performance, peripheral-blood oxidative stress, adverse events, etc.

Significance: In this study, evidence-based practice as the foundation, and perspective to design a safe and effective cycling-cognitive dual-task training for early Parkinson's disease. It can be verified in the clinical application of these experiments feasibility (practice-based evidence).

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with Idiopathic Parkinson's disease (IPD)
• an age between 45 to 70 years
• asymmetrical onset of at least 2 of 3 cardinal sign
• Modified Hoehn and Yahr staging from 1 to 2.5 during off state
• Montreal cognitive assessment score of 26 or greater

Exclusion Criteria: The patients were ineligible if they had

• a neurological history other than Parkinson's disease
• ever undergone neurosurgery for Parkinson's disease
• had moderate to severe dyskinesia
• been unstable with medical or psychiatric co-morbidities, orthopedic conditions restricting exercise
• done more than 20 min of aerobic exercise over 3 sessions per week on their own

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cognitive-Cycling; Dual-task cognitive-cycling training; cognitive and cycling training simultaneously	Other: Dual-task cognitive-cycling training; Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training; Other Names: Single-task cycling training
ACTIVE_COMPARATOR: Cycling; Single-task cycling training; stationary bicycle exercise training	Other: Dual-task cognitive-cycling training; Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training; Other Names: Single-task cycling training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's disease rating scale	There are 4 parts subscores: part 1 (0-16), part 2 (0-52), part 3 (0-96), part 4 (0-23). Total scale range 0-187 (summed part 1, 2, 3, 4), higher values represent a worse outcome.	30 minutes
Gait speed in cm/second	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Step length in cm	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Step width in cm	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Step time in second	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Double limb support time in second	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Modified Hoehn and Yahr staging	scale range 0-5. The scale was originally described in 1967 and included stages 1 through 5. It has since been modified with the addition of stages 1.5 and 2.5 to account for the intermediate course of Parkinson disease.	5 minutes
Time up and go test in second	The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility	2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance	The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) *100	10 minutes
Dual-task interference	The effect of the dual-task was calculated as the difference between single-task and dual-task performance expressed as a percentage of single-task performance	10 minutes
Adverse event	any complain from study subject	5 minutes

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chin-Song Lu, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): May 31, 2017

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (ACTUAL): October 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 201600213A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: after publishing, we will share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No