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

Parkinson's Disease Clinical Trial

— Preactive-PD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696589
• Other study ID #: 18-345
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 21, 2018
• Est. completion date: April 12, 2019

Study information

• Verified date: August 2020
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 12, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teachers College, Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change From Baseline Timed-up-and-go (TUG) at 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	baseline and 4 months
Secondary	Change From Baseline 6 Minute Walk Test at 4 Months	Assesses the distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.	baseline and 4 months
Secondary	Change From Baseline Brunel Lifestyle Inventory at 4 Months	The Brunel lifestyle inventory is a 10-item questionnaire that measures both pre-planned (6 items) and un-planned (3 items) lifestyle PA. Scoring for each item is on a scale of 1-5, and the scores for each subscale are averaged. Scores range from 1 (low level of physical activity) to 5 (high level of physical activity).	baseline and 4 months
Secondary	Change From Baseline Wechsler Adult Intelligence Scale -III (WAIS-III) Digit Span Forward and Backward at 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. Higher numbers would indicate a greater number of digits remembered (better outcome). Minimum value is 0 and there is no maximum.	baseline and 4 months
Secondary	Change From Baseline Stroop Color-Word Interference at 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.	baseline and 4 months
Secondary	Change From Baseline Canadian Occupational Performance Measure (COPM) at 4 Months	Designed to capture a client's self-perception of performance in everyday living, over time. Participants rate their performance and satisfaction of previously defined goals on a scale of 1-10, with 10 being high performance or satisfaction, and 1 being low performance or satisfaction.	baseline and 4 months
Secondary	Change From Baseline Exercise Self Efficacy Questionnaire at 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.	baseline and 4 months
Secondary	Perceived Autonomy Support Healthcare Climate Questionnaire (HCCQ) at 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 administered only the 4 month assessment. Scores on this 15-item questionnaire are calculated by averaging the individual item scores, which are rated on a 1-7 Likert scale. Scores range from 1-7, with higher average scores (7 max) represent a higher level of perceived autonomy support.	4 months
Secondary	Semi-Structured Post-intervention Questionnaire	This purpose developed post-intervention questionnaire will evaluate participant's perceptions of the intervention. Informed by the Theoretical Framework of Acceptability, the questionnaire was designed to inductively evaluate the retrospective acceptability of the intervention. Score on Likert scale 1-5, with 5 being most acceptable.	4 months