SMARTfit Training for Parkinson's Disease

NCT03921359 | Terminated

• 1 other identifier: HS-17-00928
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to investigate the effects of 8-week SMARTfit training versus conventional physical training on motor function, cognition and brain functional connectivity in individuals with PD. The investigators hypothesize that clinical and physical performance will improve after SMARTfit training more than after conventional physical training.

Conditions

Parkinson Disease; Exercise Training; Cognitive Change

Keywords

Parkinson Disease; Exercise Training; Cognitive function

Outcome Measures

Primary Outcomes (1)

• Pre-post training change in Modified Physical Performance Test score (mPPT)

  The mPPT is a 9-item test that assesses multiple dimensions of physical function (basic and complex activities of daily living) with different levels of difficulty. Participants will be asked to complete functional tasks (i.e. writing a sentence, simulated eating, lift a book and put it on a shelf, turning 360 degrees, 50-foot walking test, stair climbing etc.). Total score ranges from 0 to 36, with a higher score indicating better physical function.

  pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks)

Secondary Outcomes (8)

• Pre-post training change in MDS-UPDRS score

  pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks)

• Pre-post training change in Self-Efficacy for Exercise scale (SEES)

  pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks)

• Pre-post training change in trail-making test (TMT)

  pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks)

• Pre-post training change in Parkinson's Disease-Cognitive Rating Scale (PDCRS)

  pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks)

• Pre-post training change in Quotient system test

  pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks)

Study Arms (2)

Conventional physical training

EXPERIMENTAL

Participants assigned to this arm will receive the conventional physical training.

Behavioral: SMARTfit training; Behavioral: Conventional physical training

SMARTfit training

EXPERIMENTAL

Participants assigned to this arm will receive the SMARTfit training.

Behavioral: SMARTfit training; Behavioral: Conventional physical training

Interventions

SMARTfit training BEHAVIORAL

For SMARTfit training, participants receive three 1-hour training sessions per week for 8 weeks. During each week, participants will receive physical training focused on six tasks, which are the functional tasks individuals with PD commonly have difficulty with. The six tasks are paired into 3 pairs: (1) sit-to-stand and multi-plane locomotor tasks, (2) gait and reach \& grasp, and (3) floor-to-stand; stand-to-floor and single limb standing. Participants will focus on practicing one pair of tasks during each session. There is an additional cognition component that can be manipulated using features provided by SMARTfit.

Conventional physical training; SMARTfit training

Conventional physical training BEHAVIORAL

For conventional physical training, participants receive three 1-hour training sessions per week for 8 weeks. During each week, participants will receive physical training focused on six tasks, which are the functional tasks individuals with PD commonly have difficulty with. The six tasks are paired into 3 pairs: (1) sit-to-stand and multi-plane locomotor tasks, (2) gait and reach \& grasp, and (3) floor-to-stand; stand-to-floor and single limb standing. Participants will focus on practicing one pair of tasks during each session.

Conventional physical training; SMARTfit training

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Diagnosis of idiopathic Parkinson's disease using the UK Brain Bank criteria (as determined by the study movement disorders neurologist) with Hoehn and Yahr stage 1-2
• No contraindications to exercise including untreated cardiovascular disease or stroke
• Medically stable and optimized on their medications
• Able to ambulate independently with or without device
• No other neurologic, neuromuscular, or orthopedic disease
• No serious cognitive deficits and able to participate in the informed consent process
• With medical clearance from primary care physician to participate in the physical therapy intervention
• No contraindications for MRI

You may not qualify if:

• Severe cardiac disease (New York Heart Association classification II-IV)
• Systolic blood pressure reduction of greater than 20 mmHg with standing
• A history of poorly controlled or brittle diabetes
• A history of lower limb amputation
• Been prescribed any new dopamine replacement medications or new mood stabilizer medications.
• Presence of a lower limb non-healing ulcer
• Montreal cognitive assessment score of less than 21
• The presence of any medical condition which the investigator believes might present an unacceptable health risk to the subject should they participate in the study
• Electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
• Metal in any part of the body including metal injury to the eye
• History of brain lesions (such as stroke), seizures, or unexplained spells of loss of consciousness
• Pregnant or breast-feeding
• With other neurologic, neuromuscular, or orthopedic disease that would interfere with ability to participate in exercise training
• Currently participating in other studies

Sponsors & Collaborators

• University of Southern California: lead
• University of California, Irvine: collaborator

Study Sites (1)

USC Center for Neurorestoration

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Charles Liu, MD, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Neurological Surgery

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: April 19, 2019
• Study Start: May 19, 2018
• Primary Completion: February 2, 2020
• Study Completion: March 16, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

US (1)