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

August 26, 2020 updated by: Lori Quinn, Teachers College, Columbia University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10027
        • Teachers College, Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline and 4 months
Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2)
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). 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline and 4 months
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.
baseline and 4 months
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 (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
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. 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
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.
baseline and 4 months
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. 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
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.
baseline and 4 months
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 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
Semi-Structured Post-intervention Questionnaire
Time Frame: 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teachers College, Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lori Quinn, EdD, PT, Teachers College, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-345

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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