Clinical trial NCT03696589: Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm cohort study with pre and post intervention assessments
Primary purpose: TREATMENT

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). The investigators 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months
timeFrame: baseline and 4 months
measure: Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2)
timeFrame: baseline and 4 months
Secondary outcomes:
measure: Change From Baseline Timed-up-and-go (TUG) at 4 Months
timeFrame: baseline and 4 months
measure: Change From Baseline 6 Minute Walk Test at 4 Months
timeFrame: baseline and 4 months
measure: Change From Baseline Brunel Lifestyle Inventory at 4 Months
timeFrame: baseline and 4 months
measure: Change From Baseline Wechsler Adult Intelligence Scale -III (WAIS-III) Digit Span Forward and Backward at 4 Months
timeFrame: baseline and 4 months
measure: Change From Baseline Stroop Color-Word Interference at 4 Months
timeFrame: baseline and 4 months
measure: Change From Baseline Canadian Occupational Performance Measure (COPM) at 4 Months
timeFrame: baseline and 4 months
measure: Change From Baseline Exercise Self Efficacy Questionnaire at 4 Months
timeFrame: baseline and 4 months
measure: Perceived Autonomy Support Healthcare Climate Questionnaire (HCCQ) at 4 Months
timeFrame: 4 months
measure: Semi-Structured Post-intervention Questionnaire
timeFrame: 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Teachers College, Columbia University
name: Lori Quinn, EdD, PT
role: PRINCIPAL_INVESTIGATOR
References: