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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Lori Quinn，Teachers College, Columbia University

Tracking Information

First Submitted Date ^ICMJE

September 10, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

May 21, 2018

Estimated Primary Completion Date

September 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from Baseline Moderate-Vigorous Physical Activity using Actigraph at 4 months[ Time Frame: baseline and 4 months ]

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

Change from baseline in the Relative Autonomy Index (RAI) of the Behavioural Regulation In Exercise Questionnaire (BREQ-2) at 4 months[ Time Frame: baseline and 4 months ]

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). Subscale scores (sum totals of the 3 or 4 questions) will be reported and compared across participants. Subscales have a maximum score of 16 (12 for introjected regulation) and a minimum score of 0. An overall score (RAI-score, Relative Autonomy Index) for motivation quality will also be constructed. This is done by weighting each regulation subscale and summing them. The relative RAI is a single score derived from the subscales that gives an index of the degree to which respondents feel self-determined. Higher RAI scores denote more self-determined (autonomous) motivation.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change from Baseline Timed-up-and-go (TUG) at 4 months[ Time Frame: baseline and 4 months ]
Participant starts sitting in chair and then rises when prompted to "go" and then walks 3 meters, turns around, and walks back to chair. Time to complete is recorded
Change from Baseline 6 minute walk test at 4 months[ Time Frame: baseline and 4 months ]
Assesses the distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Change from Baseline Brunel Lifestyle Inventory at 4 months[ Time Frame: baseline and 4 months ]
The Brunel lifestyle inventory is a 10-item questionnaire that measures both pre-planned and un-planned lifestyle PA
Change from Baseline Wechsler Adult Intelligence Scale -III (WAIS-III) Digit Span Forward and Backward at 4 months[ Time Frame: baseline and 4 months ]
This test evaluates the number of digits a person can remember in both a forward and backward recall. WAIS-III subscale measures sequential processing, mental manipulation, attention, concentration, memory span, and short-term auditory memory
Change from Baseline Stroop Color-Word Interference at 4 months[ Time Frame: baseline and 4 months ]
This test evaluates the ability to state the color of a word but not the written word. The cognitive dimension tapped by the Stroop is associated with cognitive flexibility, resistance to interference from outside stimuli, creativity, and psychopathology. The number of correct words in 45 seconds is recorded.
Change from Baseline Canadian Occupational Performance Measure (COPM) at 4 months[ Time Frame: baseline and 4 months ]
Designed to capture a client's self-perception of performance in everyday living, over time.
Change from Baseline Exercise Self Efficacy Questionnaire at 4 months[ Time Frame: baseline and 4 months ]
18-item test that measures an individual's self-efficacy to participate in exercise when numerous barriers are present, including both social and physical barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Change from Baseline Perceived Autonomy Support Healthcare Climate Questionnaire (HCCQ) at 4 months[ Time Frame: 4 months ]
The Perceived Autonomy Support Healthcare Climate Questionnaire is from the Health-Care, Self-Determination Theory Questionnaire Packet that was designed to assess constructs encompassed within Self-Determination Theory (SDT) as it applies to health-care behavior. This is a measure of acceptability of the intervention. Scores on this 15-item questionnaire are calculated by averaging the individual item scores. Higher average scores (15 max) represent a higher level of perceived autonomy support.
Semi-Structured post-intervention questionnaire[ Time Frame: 4 months ]
This purpose developed post-intervention questionnaire will evaluate participant's perceptions of the intervention

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Improving Self-efficacy, Automaticity, and Physical Activity Levels in People With Parkinson's Disease

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.

Detailed Description

The investigators will recruit 14 individuals with early stage Parkinson's disease (Hoehn and Yahr stage I & II). We will conduct a single arm cohort. (pre and post intervention) pilot feasibility study over 4 months with embedded process analyses of Preactive-HD, a physical activity coaching intervention program. Previous studies conducted by the investigators will be utilized to adapt the Engage-HD physical activity coaching program to people with early stage PD. The intervention will include a participant/coach interaction and disease-specific workbook grounded within the framework of self-determination theory. The coaching sessions will be conducted by an occupational therapist and will entail six coaching sessions (either face-to-face or remote video sessions via secure Webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant). The first session (approximately 45 min) will lay the groundwork for the program, and the remaining sessions will serve to provide directed support in relation to regular physical activity and exercise. Participants will develop physical activity goals and will be supported with individual physical activity progression. Participants will be given Fitbit devices as a motivational tool and to track activity progression.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1/Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm cohort study with pre and post intervention assessments
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Physical Activity Coaching
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.

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 1, 2019

Estimated Primary Completion Date

September 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. Neurologist confirmed clinical dx for Parkinson's disease Hoehn & Yahr stage I or II 2. Ambulatory for indoor and outdoor mobility without assistance or assistive device 3. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) (Thomas et al., 1992), or medical clearance from GP Exclusion Criteria: 1. Musculoskeletal injury that would prevent participation in an exercise program 2. Other neurological disease or disorder such as stroke 3. Already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Lori Quinn，Teachers College, Columbia University

Study Sponsor ^ICMJE

Teachers College, Columbia University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Lori Quinn, EdD, PT Teachers College, Columbia University

PRS Account

Teachers College, Columbia University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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