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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Safety and Effectiveness

Treatments

Other: Dual-task cognitive-cycling training

Study type

Interventional

Funder types

Other

Identifiers

NCT04114318
201600213A3

Details and patient eligibility

About

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

Full 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).

Enrollment

26 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Cognitive-Cycling
Experimental group
Description:
Dual-task cognitive-cycling training; cognitive and cycling training simultaneously
Treatment:
Other: Dual-task cognitive-cycling training
Cycling
Active Comparator group
Description:
Single-task cycling training; stationary bicycle exercise training
Treatment:
Other: Dual-task cognitive-cycling training

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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