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

Safety and Effectiveness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114318
• Other study ID #: 201600213A3
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: August 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Safety and Effectiveness

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Gait speed in cm/second	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Primary	Step length in cm	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Primary	Step width in cm	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Primary	Step time in second	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Primary	Double limb support time in second	using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway	5 minutes
Primary	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
Primary	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	Cognitive performance	The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) *100	10 minutes
Secondary	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
Secondary	Adverse event	any complain from study subject	5 minutes