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Benefits of Different Exercise Types to Enhance Walking for PD

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Gait + aerobic exercise
Gait + resistance exercises
Gait + conventional physical therapy
Gait + rest
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Skill learning, Transcranial magnetic stimulation, Gait training, Aerobic exercise, Resistance exercise

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic Parkinson's Disease
  • Able to follow instructions to perform the tasks
  • The Montreal Cognitive Assessment, MoCA ≥ 20
  • Be able to walk independently with or without devices for at least 10 meters

Exclusion Criteria:

  • Has deep brain stimulation or pacemaker implanted in their body
  • A self-history of seizure
  • A family-history of epilepsy
  • Pregnancy
  • Uncontrolled medical conditions
  • Unstable cardiovascular diseases
  • Has other neurological or psychological disorders in addition to Parkinson's Disease

Sites / Locations

  • National Taiwan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Aerobic exercise group (AEX)

Resistance exercise group (REX)

Conventional physical therapy group (CPT)

Control group (CON)

Arm Description

Gait training followed by 20 minutes of moderate to high intensity aerobic exercise on a recumbent bicycle.

Gait training followed by 20 minutes of resistance training targeting major muscle groups.

Gait training followed by 20 minutes of conventional PT programs that do not involve aerobic or resistance exercise.

Gait training followed by 20 minutes of rest (sitting on a chair and read magazines).

Outcomes

Primary Outcome Measures

Change in gait performances
The participants will be required to walk along a walkway with their comfortable walking speed, fastest walking speed and under dual task condition for 3 times each. The gait performances will be captured by the Physilog®5 system (Gait Up, Renens, Switzerland), which include two inertial sensors with built-in 3D accelerometers and gyroscopes.Gait performances in pretest, mid-test, post-test, and follow-up test will be evaluated, and the trend of changes will be determined.

Secondary Outcome Measures

Change in Montreal Cognitive Assessment (MoCA)
The MoCA will be used to evaluate general cognitive function of the participants. It evaluates several cognitive functions including attention, set-shifting, short-term memory, verbal fluency, calculation, orientation, digit span, conceptual thinking, and visuospatial processing skills. The total score of MoCA is 30 with a higher score indicating better cognitive function. The MoCA has good to excellent psychometric properties. MoCA will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in the Stroop Color-Word test
The Stroop Color-Word test will be used to evaluate the changes in executive functions in people with PD. The executive functions involved in the Stroop Color-Word test are selective attention, inhibition, and set-shifting. The Stroop Color-Word test comprises the congruent and incongruent testing conditions. The congruent condition is when the color ink of a word is coherent with the written color name, and the incongruent condition is when the color ink differs from the written color name (e.g., the word 'red' written in blue ink). The participants are instructed to read out the ink color of the word, but not the color word name, as accurately and as fast as possible within 45 seconds. The Stroop Color-Word test will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in the Unified Parkinson's Disease Rating Scale (UPDRS)
The Unified Parkinson's Disease Rating Scale (UPDRS) is a well-established and widely used rating tool for the evaluation of disease severity of PD. This study will only evaluate Part 3 of the scale - the motor disturbances of the patients. The total score ranges from 0 to 132 for Part 3 of the UPDRS with a lower score indicates less PD symptoms and a higher score suggests more severe in PD disease. Internal consistency and validity has been established to be excellent for UPDRS. UPDRS will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in fatigue severity questionnaire (FSS)
The FSS will be used to determine how fatigue interferes an individual's daily living and social participation. It contains 9 items, and each item is scored on a 7-point scale with a score 1 indicates strongly disagree and score 7 indicates strongly agree. The total score ranges from 9 to 63, with a higher score indicate greater fatigue severity. FSS will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in Activities-Specific Balance Confidence (ABC) Scale
The Activities-Specific Balance Confidence (ABC) scale will be used to examine an individual's confidence level of not falling when performing activities of daily living. The ABC Scale contains 16 different activities performed indoors and outdoors. The participants will be asked to rate their confidence level (range from 0% to 100% of confidence) of not falling for each item. An average score of the 16 items (range from 0% to 100%) will be calculated to determine the participant's confidence level of not falling when performing the activities of daily living. The internal consistency and test-retest reliability of the ABC scale in patients with PD were excellent. The ABC scale will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in Parkinson's Disease Questionnaire-39 (PDQ-39)
The PDQ-39 is a self-report questionnaire containing 39 items assessing the impact of PD on quality of life. The PDQ-39 covers 8 dimensions: mobility, activities of daily living, emotional well-being, stigma, cognition, communication, and bodily discomfort. The participants are required to answer the questions based on their experiences in the preceding month prior to the interview. The scoring system for each item ranges from 0 (never have difficulty) to 4 (always have difficulty) with lower scores suggesting better quality of life. PDQ-39 will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in New Freezing of Gait Questionnaire (NFOG-Q)
The NFOG-Q will be used to evaluate the freezing frequency and severity of the patients with PD. It composes of 3 parts; in the first part, a video clip will be shown to the participants with PD and help to classify whether an individual is a freezer or non-freezer. The second and third part of the questionnaire is designed for freezers only. PartⅡassesses the severity of FoG according to the frequency and duration of the freezing episodes, while PartⅢevaluates the impact of freezing on daily activities, such as walking. The reliability and internal consistency of the NFOG-Q have been well-established for patients with PD. NFOG-Q will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in Geriatric Depression Scale (GDS)
The GDS is a self-report measure of depression in older adults. The GDS contains 15 items, and the users respond in a "Yes/No" format to each question in reference to the past 1 week. GDS will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in The Timed Up and Go (TUG) Test
The participants will initially sit on a comfortable chair with hips and knees flexed at 90°. Upon a 'GO' signal, the participants will stand up from the chair, walk for 3 meters, turn around, walk back to the chair, and sit down. The participants will be instructed to complete the task at their preferred/ comfortable speed. Good to excellent test-retest reliability and inter-rater reliability have been established in people with PD. TUG will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in Five Times Sit-to-Stand (FTSTS) Test
The FTSTS test will be evaluated to represent the strength and endurance of the lower limbs. The participants will be sat on a standardized chair, and they will be required to stand up and then sit down for 5 times as fast as possible. The amount of time the participants need to complete the task will be recorded, and a lesser amount of times would indicate better strength of the lower extremities. FTSTS will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in motor evoked potential (MEP)
Transcranial magnetic stimulation (TMS) will be used to evaluate the MEP. Peak-to-peak MEP amplitude is an indicator of the integrity and excitability of the corticospinal tract. MEP will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in cortical silent period (CSP)
Transcranial magnetic stimulation (TMS) will be used to evaluate the CSP. The CSP is a period when EMG activity being suppressed for a few hundred milliseconds after the MEP, and has often been used as an indicator of the inhibitory mechanism occurs within the corticospinal tract. CSP will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in intracortical inhibition and facilitation
Paired pulse TMS will be used to evaluate the intracortical inhibition and facilitation. Intracortical inhibition and facilitation will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in muscle strength of lower extremity muscles
Hand-held dynamometer will be used to measure changes in muscle strength. The muscle groups in interest are hip flexors and extensors, knee flexors and extensors, and ankle dorsiflexors. Measurement of each muscle group will be repeated 3 times and an average score will be recorded. Muscle strength will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Change in six-minute walk test (6MWT)
The 6MWT will be used to measure the muscle endurance and cardiopulmonary function of the participants. The participants will be required to walk back and forth along a 30-meter walkway continuously for 6 minutes. Participants will be instructed to walk as far as possible within the 6 minutes. If they are too tired to continue walking, they will be allowed to rest as needed but resume walking as soon as possible. Total distance that the participants walk will be recorded. Additionally, heart rate and RPE will also be recorded immediately after the test. The 6MWT will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.

Full Information

First Posted
May 13, 2021
Last Updated
November 28, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04895787
Brief Title
Benefits of Different Exercise Types to Enhance Walking for PD
Official Title
Augmented Benefits of Different Exercise Types to Enhance Skill Learning in People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Gait disturbance is one of the most common complaints from patients with Parkinson's disease (PD). It is well-established that people with PD have motor learning impairments. To enhance motor learning, several methods have been recommended, such as sleep, non-invasive brain stimulation techniques, and aerobic exercise. To date, only 2 studies have investigated the effects of acute aerobic exercise on motor learning in people with PD. It is yet unclear whether adding aerobic exercise after multiple motor training sessions can enhance motor learning in people with PD. Additionally, most prior evidences utilized moderate to high intensity aerobic exercise to facilitate motor learning, it is yet unclear whether other types of exercise (e.g., resistance training) could induce similar beneficial effects. Therefore, this proposed project is specifically designed to investigate the effects of adding aerobic or resistance exercise after motor training. To take a step further, this project will also determine the patient characteristics who may benefit from the intervention. Objectives: (1) To examine whether adding specific exercise after training can facilitate learning on patients with Parkinson's disease. (2) To determine the characteristics of participants who may benefit from these types of intervention approach. Methods: A total of 76 participants with idiopathic PD diagnosed by neurologists will be recruited. All eligible participants will be randomized into one of the 4 groups: aerobic group (AEX), resistance group (REX), conventional PT group (CPT), and control group (CON). All participants will receive 12 sessions of gait training. All outcome measures will be assessed before the intervention (pre-test), after the 6th intervention session (mid-test), after all 12 intervention sessions (post-test), and 1-month after the intervention (follow-up test). All assessments will be performed by an independent research assistant who will be blinded to the group allocation of the participants. The primary outcome will be gait performance, and the secondary outcomes will include measurements of cognitive and behavioral functions. Additionally, transcranial magnetic stimulation will be used to examine the changes of corticomotor excitability associated with the interventions.
Detailed Description
Background: Gait disturbance is one of the most common complaints from patients with Parkinson's disease (PD). It is well-established that due to the dysfunction of the corticostriatal circuits, people with PD have motor learning impairments and may consequently influence the effects of rehabilitation. To enhance motor learning, several methods have been recommended, such as sleep, non-invasive brain stimulation techniques, and aerobic exercise. To date, only 2 studies have investigated the effects of acute aerobic exercise on motor learning in people with PD. These 2 studies were cross-sectional studies that only provided a single bout of aerobic exercise and followed the effects on motor learning for 7 days. It is yet unclear whether adding aerobic exercise after goal-based motor skill training for multiple training sessions, like a regular clinical treatment regimen, can boost up the speed of motor skill acquisition and enhance retention and transfer performances for people with PD. Additionally, most prior evidences utilized moderate to high intensity aerobic exercise to facilitate motor learning, it is yet unclear whether other types of exercise (e.g., resistance training) could induce similar beneficial effects. To the best of our knowledge, no study is specifically designed to compare the addictive effect of aerobic or resistance exercise on motor skill learning in people with PD. Therefore, this proposed project is specifically designed to answer the above questions. To take a step further, this project will also determine the patient characteristics who may benefit from the intervention. Objectives: (1) To examine whether adding aerobic or resistance exercise after walking skill training can facilitate learning of the walking task on patients with Parkinson's disease. (2) To determine the characteristics of participants who may benefit from these types of intervention approach. The first aim of this study is to investigate investigate the effects of adding aerobic or resistance exercise after gait training in people with PD. The second aim is to further determine the characteristics of participants who benefit from the proposed training program.. Methods: A total of 76 participants with idiopathic PD diagnosed by neurologists will be recruited. All eligible participants will be randomized into one of the 4 groups: aerobic group (AEX), resistance group (REX), conventional PT group (CPT), and control group (CON). All participants will receive one-on-one intervention sessions with a trained physical therapist. Each intervention sessions will last 60 minutes, which will include 30 minutes of treadmill training and an additional therapy based on group allocation. The participants will come to the lab for 12 training sessions spread across 4 to 6 weeks. All outcome measures will be assessed before the intervention (pre-test), after the 6th intervention session (mid-test), after all 12 intervention sessions (post-test), and 1-month after the intervention (follow-up test). All assessments will be performed by an independent research assistant who will be blinded to the group allocation of the participants. The primary outcome will be gait performance, and the secondary outcomes will include Montreal Cognitive Assessment test, Stroop Color-Word test, Unified Parkinson's Disease Rating Scale, Fatigue Severity Scale, Activities-Specific Balance Confidence Scale, Parkinson's Disease Questionnaire-39, New Freezing of Gait Questionnaire, Geriatric Depression Scale, finger sequence task, Timed Up and Go test, 5 times sit to stand test. Transcranial magnetic stimulation will be used to examine the changes of corticomotor excitability associated with the interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic
Keywords
Parkinson's disease, Skill learning, Transcranial magnetic stimulation, Gait training, Aerobic exercise, Resistance exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The researcher(s) who will conduct the outcome assessments will be masked from the group allocation.
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise group (AEX)
Arm Type
Experimental
Arm Description
Gait training followed by 20 minutes of moderate to high intensity aerobic exercise on a recumbent bicycle.
Arm Title
Resistance exercise group (REX)
Arm Type
Experimental
Arm Description
Gait training followed by 20 minutes of resistance training targeting major muscle groups.
Arm Title
Conventional physical therapy group (CPT)
Arm Type
Active Comparator
Arm Description
Gait training followed by 20 minutes of conventional PT programs that do not involve aerobic or resistance exercise.
Arm Title
Control group (CON)
Arm Type
Active Comparator
Arm Description
Gait training followed by 20 minutes of rest (sitting on a chair and read magazines).
Intervention Type
Behavioral
Intervention Name(s)
Gait + aerobic exercise
Other Intervention Name(s)
gait training and aerobic exercise on a recumbent bicycle
Intervention Description
Following skill-based gait training, the participants in the AEX group will engage in 20 minutes of moderate to high intensity aerobic exercise on a recumbent bicycle. The participants will first perform a brief warm-up, followed by 20 minutes of moderate to high intensity aerobic exercise pedaling at 60-80 rpm with a target heart rate range between 60-70% of heart rate reserve (HRR). Given the potential of having autonomic dysfunction in this population, it has been suggested that a RPE scale between 14-17 is appropriate.
Intervention Type
Behavioral
Intervention Name(s)
Gait + resistance exercises
Other Intervention Name(s)
gait training and muscle strengthening exercise
Intervention Description
Following skill-based gait training, the participants in the REX group will engage in resistance training, which will target major muscle groups important for daily activities. The resistance training will be provided with free weights or therabands at an intensity of 8-12 repetition maximum (RM). Each muscle group should be trained with 8-12 repetitions ranging from 1 to 3 sets with resting intervals provided between each set. The target RPE scale will be set between 14-17, and the training load will be progressively increased as the participants improved.
Intervention Type
Behavioral
Intervention Name(s)
Gait + conventional physical therapy
Other Intervention Name(s)
gait training and conventional physical therapy
Intervention Description
Following skill-based gait training, the participants in the CPT group will receive conventional physical therapy, which may include stretching exercise, balance training, or practice over-ground walking based on the participant's need.
Intervention Type
Behavioral
Intervention Name(s)
Gait + rest
Other Intervention Name(s)
gait training and rest
Intervention Description
Following skill-based gait training, the participants will sit and rest on a chair.
Primary Outcome Measure Information:
Title
Change in gait performances
Description
The participants will be required to walk along a walkway with their comfortable walking speed, fastest walking speed and under dual task condition for 3 times each. The gait performances will be captured by the Physilog®5 system (Gait Up, Renens, Switzerland), which include two inertial sensors with built-in 3D accelerometers and gyroscopes.Gait performances in pretest, mid-test, post-test, and follow-up test will be evaluated, and the trend of changes will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Secondary Outcome Measure Information:
Title
Change in Montreal Cognitive Assessment (MoCA)
Description
The MoCA will be used to evaluate general cognitive function of the participants. It evaluates several cognitive functions including attention, set-shifting, short-term memory, verbal fluency, calculation, orientation, digit span, conceptual thinking, and visuospatial processing skills. The total score of MoCA is 30 with a higher score indicating better cognitive function. The MoCA has good to excellent psychometric properties. MoCA will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in the Stroop Color-Word test
Description
The Stroop Color-Word test will be used to evaluate the changes in executive functions in people with PD. The executive functions involved in the Stroop Color-Word test are selective attention, inhibition, and set-shifting. The Stroop Color-Word test comprises the congruent and incongruent testing conditions. The congruent condition is when the color ink of a word is coherent with the written color name, and the incongruent condition is when the color ink differs from the written color name (e.g., the word 'red' written in blue ink). The participants are instructed to read out the ink color of the word, but not the color word name, as accurately and as fast as possible within 45 seconds. The Stroop Color-Word test will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in the Unified Parkinson's Disease Rating Scale (UPDRS)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) is a well-established and widely used rating tool for the evaluation of disease severity of PD. This study will only evaluate Part 3 of the scale - the motor disturbances of the patients. The total score ranges from 0 to 132 for Part 3 of the UPDRS with a lower score indicates less PD symptoms and a higher score suggests more severe in PD disease. Internal consistency and validity has been established to be excellent for UPDRS. UPDRS will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in fatigue severity questionnaire (FSS)
Description
The FSS will be used to determine how fatigue interferes an individual's daily living and social participation. It contains 9 items, and each item is scored on a 7-point scale with a score 1 indicates strongly disagree and score 7 indicates strongly agree. The total score ranges from 9 to 63, with a higher score indicate greater fatigue severity. FSS will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in Activities-Specific Balance Confidence (ABC) Scale
Description
The Activities-Specific Balance Confidence (ABC) scale will be used to examine an individual's confidence level of not falling when performing activities of daily living. The ABC Scale contains 16 different activities performed indoors and outdoors. The participants will be asked to rate their confidence level (range from 0% to 100% of confidence) of not falling for each item. An average score of the 16 items (range from 0% to 100%) will be calculated to determine the participant's confidence level of not falling when performing the activities of daily living. The internal consistency and test-retest reliability of the ABC scale in patients with PD were excellent. The ABC scale will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in Parkinson's Disease Questionnaire-39 (PDQ-39)
Description
The PDQ-39 is a self-report questionnaire containing 39 items assessing the impact of PD on quality of life. The PDQ-39 covers 8 dimensions: mobility, activities of daily living, emotional well-being, stigma, cognition, communication, and bodily discomfort. The participants are required to answer the questions based on their experiences in the preceding month prior to the interview. The scoring system for each item ranges from 0 (never have difficulty) to 4 (always have difficulty) with lower scores suggesting better quality of life. PDQ-39 will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in New Freezing of Gait Questionnaire (NFOG-Q)
Description
The NFOG-Q will be used to evaluate the freezing frequency and severity of the patients with PD. It composes of 3 parts; in the first part, a video clip will be shown to the participants with PD and help to classify whether an individual is a freezer or non-freezer. The second and third part of the questionnaire is designed for freezers only. PartⅡassesses the severity of FoG according to the frequency and duration of the freezing episodes, while PartⅢevaluates the impact of freezing on daily activities, such as walking. The reliability and internal consistency of the NFOG-Q have been well-established for patients with PD. NFOG-Q will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in Geriatric Depression Scale (GDS)
Description
The GDS is a self-report measure of depression in older adults. The GDS contains 15 items, and the users respond in a "Yes/No" format to each question in reference to the past 1 week. GDS will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in The Timed Up and Go (TUG) Test
Description
The participants will initially sit on a comfortable chair with hips and knees flexed at 90°. Upon a 'GO' signal, the participants will stand up from the chair, walk for 3 meters, turn around, walk back to the chair, and sit down. The participants will be instructed to complete the task at their preferred/ comfortable speed. Good to excellent test-retest reliability and inter-rater reliability have been established in people with PD. TUG will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in Five Times Sit-to-Stand (FTSTS) Test
Description
The FTSTS test will be evaluated to represent the strength and endurance of the lower limbs. The participants will be sat on a standardized chair, and they will be required to stand up and then sit down for 5 times as fast as possible. The amount of time the participants need to complete the task will be recorded, and a lesser amount of times would indicate better strength of the lower extremities. FTSTS will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in motor evoked potential (MEP)
Description
Transcranial magnetic stimulation (TMS) will be used to evaluate the MEP. Peak-to-peak MEP amplitude is an indicator of the integrity and excitability of the corticospinal tract. MEP will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in cortical silent period (CSP)
Description
Transcranial magnetic stimulation (TMS) will be used to evaluate the CSP. The CSP is a period when EMG activity being suppressed for a few hundred milliseconds after the MEP, and has often been used as an indicator of the inhibitory mechanism occurs within the corticospinal tract. CSP will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in intracortical inhibition and facilitation
Description
Paired pulse TMS will be used to evaluate the intracortical inhibition and facilitation. Intracortical inhibition and facilitation will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in muscle strength of lower extremity muscles
Description
Hand-held dynamometer will be used to measure changes in muscle strength. The muscle groups in interest are hip flexors and extensors, knee flexors and extensors, and ankle dorsiflexors. Measurement of each muscle group will be repeated 3 times and an average score will be recorded. Muscle strength will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
Title
Change in six-minute walk test (6MWT)
Description
The 6MWT will be used to measure the muscle endurance and cardiopulmonary function of the participants. The participants will be required to walk back and forth along a 30-meter walkway continuously for 6 minutes. Participants will be instructed to walk as far as possible within the 6 minutes. If they are too tired to continue walking, they will be allowed to rest as needed but resume walking as soon as possible. Total distance that the participants walk will be recorded. Additionally, heart rate and RPE will also be recorded immediately after the test. The 6MWT will be assessed at pretest, mid-test, post-test, and follow-up test, and the trend of changes among these time points will be determined.
Time Frame
Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's Disease Able to follow instructions to perform the tasks The Montreal Cognitive Assessment, MoCA ≥ 20 Be able to walk independently with or without devices for at least 10 meters Exclusion Criteria: Has deep brain stimulation or pacemaker implanted in their body A self-history of seizure A family-history of epilepsy Pregnancy Uncontrolled medical conditions Unstable cardiovascular diseases Has other neurological or psychological disorders in addition to Parkinson's Disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Yun Lee, PhD
Phone
+886-2-3366-8155
Email
yayunlee@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Yun Lee, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University
City
Taipei
ZIP/Postal Code
10055
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yayun Lee, PhD
Phone
+886-2-33668155
Email
yayunlee@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Benefits of Different Exercise Types to Enhance Walking for PD

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