Benefits of Different Exercise Types to Enhance Walking for PD

NCT ID: NCT04895787

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2024-07-31

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic exercise group (AEX)

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

Group Type: EXPERIMENTAL

Gait + aerobic exercise

Intervention Type: BEHAVIORAL

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.

Resistance exercise group (REX)

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

Group Type: EXPERIMENTAL

Gait + resistance exercises

Intervention Type: BEHAVIORAL

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.

Conventional physical therapy group (CPT)

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

Group Type: ACTIVE_COMPARATOR

Gait + conventional physical therapy

Intervention Type: BEHAVIORAL

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.

Control group (CON)

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

Group Type: ACTIVE_COMPARATOR

Gait + rest

Intervention Type: BEHAVIORAL

Following skill-based gait training, the participants will sit and rest on a chair.

Interventions

Gait + aerobic exercise

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

Gait + resistance exercises

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

Gait + conventional physical therapy

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

Gait + rest

Following skill-based gait training, the participants will sit and rest on a chair.

Intervention Type: BEHAVIORAL

Other Intervention Names

gait training and aerobic exercise on a recumbent bicycle; gait training and muscle strengthening exercise; gait training and conventional physical therapy; gait training and rest

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ya-Yun Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National Taiwan University

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ya-Yun Lee, PhD

Role: CONTACT

yayunlee@ntu.edu.tw

+886-2-3366-8155

Facility Contacts

Yayun Lee, PhD

Role: primary

yayunlee@ntu.edu.tw

+886-2-33668155

Other Identifiers

202012147RIND

Identifier Type: -

Identifier Source: org_study_id