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Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease (Preactive-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03696589
Recruitment Status : Active, not recruiting
First Posted : October 4, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Lori Quinn, Teachers College, Columbia University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Physical Activity Coaching Phase 1 Phase 2

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.

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Semi-Structured post-intervention questionnaire [ Time Frame: 4 months ]
    This purpose developed post-intervention questionnaire will evaluate participant's perceptions of the intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, New York
Teachers College, Columbia University
New York, New York, United States, 10027
Sponsors and Collaborators
Teachers College, Columbia University
Investigators
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Principal Investigator: Lori Quinn, EdD, PT Teachers College, Columbia University

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Responsible Party: Lori Quinn, Associate Professor, Teachers College, Columbia University
ClinicalTrials.gov Identifier: NCT03696589    
Other Study ID Numbers: 18-345
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases