Benefits of Different Exercise Types to Enhance Walking for PD

NCT04895787 | Unknown

• 1 other identifier: 202012147RIND
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

Parkinson's disease; Skill learning; Transcranial magnetic stimulation; Gait training; Aerobic exercise; Resistance exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (15)

• Change in Montreal Cognitive Assessment (MoCA)

  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)

• Change in the Stroop Color-Word test

  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)

• Change in the Unified Parkinson's Disease Rating Scale (UPDRS)

  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)

• Change in fatigue severity questionnaire (FSS)

  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)

• Change in Activities-Specific Balance Confidence (ABC) Scale

  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)

Study Arms (4)

Aerobic exercise group (AEX)

EXPERIMENTAL

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

Behavioral: Gait + aerobic exercise

Resistance exercise group (REX)

EXPERIMENTAL

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

Behavioral: Gait + resistance exercises

Conventional physical therapy group (CPT)

ACTIVE COMPARATOR

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

Behavioral: Gait + conventional physical therapy

Control group (CON)

ACTIVE COMPARATOR

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

Behavioral: Gait + rest

Interventions

Gait + aerobic exercise 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.

Also known as: gait training and aerobic exercise on a recumbent bicycle

Aerobic exercise group (AEX)

Gait + resistance exercises 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.

Also known as: gait training and muscle strengthening exercise

Resistance exercise group (REX)

Gait + conventional physical therapy 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.

Also known as: gait training and conventional physical therapy

Conventional physical therapy group (CPT)

Gait + rest BEHAVIORAL

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

Also known as: gait training and rest

Control group (CON)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, 10055, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Interventions

Gait; Exercise; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity

Study Officials

• Ya-Yun Lee, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Yun Lee, PhD

CONTACT

+886-2-3366-8155; yayunlee@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher(s) who will conduct the outcome assessments will be masked from the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 20, 2021
• Study Start: December 7, 2021
• Primary Completion: May 1, 2024
• Study Completion: July 31, 2024
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

TW (1)