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Parkinson's DiseasePhase 1/2Preactive-PDNCT03696589

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

A Phase 1/2 study testing Physical Activity Coaching in people with Parkinson's Disease, run by Teachers College, Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Physical Activity Coaching
How many people
13 participants
Where
1 siteUnited States
Study dates
21 May 2018to 12 Apr 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Neurologist confirmed clinical dx for Parkinson's disease Hoehn \& Yahr stage I or II
  • Ambulatory for indoor and outdoor mobility without assistance or assistive device
  • Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) (Thomas et al., 1992), or medical clearance from GP

Who cannot join

  • Musculoskeletal injury that would prevent participation in an exercise program
  • Other neurological disease or disorder such as stroke
  • Already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Teachers College, Columbia University

    New York, New York, 10027

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Physical Activity Coaching
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity CoachingBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and 4 months

  2. 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).

    Measured: baseline and 4 months

Secondary outcomes (9)

  1. 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

    Measured: baseline and 4 months

  2. 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.

    Measured: baseline and 4 months

  3. 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).

    Measured: baseline and 4 months

  4. 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.

    Measured: baseline and 4 months

  5. 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.

    Measured: baseline and 4 months

  6. 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.

    Measured: baseline and 4 months

  7. 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.

    Measured: baseline and 4 months

  8. 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.

    Measured: 4 months

  9. 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2018
  2. Study start21 May 2018
  3. Primary completion5 Apr 2019
  4. Study completion12 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm cohort study with pre and post intervention assessments
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696589
Sponsor's protocol ID
18-345
Acronym
Preactive-PD
Status last verified
Aug 2020
First submitted
10 Sep 2018
Last updated
16 Sep 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Physical Activity Coaching in people with Parkinson's Disease, run by Teachers College, Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months (time frame: baseline and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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