Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease

NCT03696589 | Completed Phase 1 Results

• 1 other identifier: 18-345
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the feasibility, in regards to acceptability and implementation, of the Pre-Active PD intervention for increased high intensity goal-directed aerobic exercise engagement in people with early-stage Parkinson's disease (Hoehn and Yahr stage I \& II). In addition, the study aims to explore the effect estimates of the Pre-Active PD intervention on self-efficacy, motivation, stage of behavior change, and physical activity levels in people with early stage Parkinson's disease.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months

  Measured using Actigraph accelerometer, levels of moderate-vigorous physical activity will be measured, as well as number of steps and sedentary behavior.

  baseline and 4 months

• Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2)

  The BREQ-2 is a 19-item questionnaire that measures each of the subscales of the self-determination continuum: external, introjected, identified, and intrinsic regulations, as well as amotivation. Each subscale is represented by 4 questions, except for introjected regulation which has 3. Questions are scored using a 5-point Likert scale; Answers range from 0 (not true for me) to 4 (very true for me). Composite scores were calculated from these subscales. Autonomous motivation was calculated from the intrinsic motivation and identified regulation subscales, with possible scores ranging from 0 (low autonomous motivation) to 4 (high autonomous motivation. Controlled motivation was calculated from the introjected regulation and external regulation subscales, with possible scores ranging from 0 (low controlled motivation) to 4 (high controlled motivation).

  baseline and 4 months

Secondary Outcomes (9)

• Change From Baseline Timed-up-and-go (TUG) at 4 Months

  baseline and 4 months

• Change From Baseline 6 Minute Walk Test at 4 Months

  baseline and 4 months

• Change From Baseline Brunel Lifestyle Inventory at 4 Months

  baseline and 4 months

• Change From Baseline Wechsler Adult Intelligence Scale -III (WAIS-III) Digit Span Forward and Backward at 4 Months

  baseline and 4 months

• Change From Baseline Stroop Color-Word Interference at 4 Months

  baseline and 4 months

Interventions

Physical Activity Coaching BEHAVIORAL

Based in the self-determination theory, participants will be coached on beneficial exercises, how to utilize supports and overcome barriers to PA engagement. Emphasis of exercise coaching will be on increasing aerobic exercise engagement and will include us of Fitbit devices to facilitate uptake and monitor aerobic exercise. Intervention will be delivered by a physical or occupational therapist, who will work with the participant to develop a plan, set goals and targets, and track changes. Additional resources that will support exercise engagement will be provided. Participants will have the choice to receive their face-to-face session either in person or remotely via secure video-based service.

Eligibility Criteria

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

You may qualify if:

• Neurologist confirmed clinical dx for Parkinson's disease Hoehn \& Yahr stage I or II
• Ambulatory for indoor and outdoor mobility without assistance or assistive device
• Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) (Thomas et al., 1992), or medical clearance from GP

You may not qualify if:

• Musculoskeletal injury that would prevent participation in an exercise program
• Other neurological disease or disorder such as stroke
• Already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week.

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, 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

Results Point of Contact

• Title: Lori Quinn
• Organization: Teachers College, Columbia University

lq2165@tc.columbia.edu

212-678-3424

Study Officials

• Lori Quinn, EdD, PT

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single arm cohort study with pre and post intervention assessments

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: October 4, 2018
• Study Start: May 21, 2018
• Primary Completion: April 5, 2019
• Study Completion: April 12, 2019
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Locations

US (1)