Clinical trial NCT06355947: Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement
Official title: Cycling Induced Motor Cortex Plasticity and Functional Improvement -the Dual Task Evaluation Model for Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease(PD)
Keywords: Gait
Cycling training
Treadmill training
Dual-task walking
Dual-task cycling
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.

Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.

Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.

The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.

The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.

The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability.


Eligibility criteria: Health subjects:

Exclusion Criteria:

* Musculoskeletal injuries on legs.
* Osteoporosis.

PD subjects:

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

* Musculoskeletal injuries on legs
* Osteoporosis.
* Any peripheral or central nervous system injury or disease patients.

Primary outcomes:
measure: Walking Speed
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Step Length
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Step Time
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Power Spectral Density (PSD)
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Task Accuracy
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Reaction Time
timeFrame: Baseline, 4 weeks and 8 weeks.
measure: Balance Performance
timeFrame: Baseline, 4 weeks and 8 weeks
Secondary outcomes:
measure: Double Support Time
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Single Support Time
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Swing Time
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Stance Time
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Cadence
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Heart rate
timeFrame: Baseline
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References: