Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease (Preactive-PD)
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|ClinicalTrials.gov Identifier: NCT03696589|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2018
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Behavioral: Physical Activity Coaching||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm cohort study with pre and post intervention assessments|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696589
|United States, New York|
|Teachers College, Columbia University|
|New York, New York, United States, 10027|
|Principal Investigator:||Lori Quinn, EdD, PT||Teachers College, Columbia University|