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

NCT04114318 | Completed

• 1 other identifier: 201600213A3
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Safety and Effectiveness

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Cognitive performance

  10 minutes

• Dual-task interference

  10 minutes

• Adverse event

  5 minutes

Study Arms (2)

Cognitive-Cycling

EXPERIMENTAL

Dual-task cognitive-cycling training; cognitive and cycling training simultaneously

Other: Dual-task cognitive-cycling training

Cycling

ACTIVE COMPARATOR

Single-task cycling training; stationary bicycle exercise training

Other: Dual-task cognitive-cycling training

Interventions

Dual-task cognitive-cycling training OTHER

Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training

Also known as: Single-task cycling training

Cognitive-Cycling; Cycling

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Officials

• Chin-Song Lu, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: October 3, 2019
• Study Start: June 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: October 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share