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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03696589

Acronym

Preactive-PD

Enrollment

Registered

2018-10-04

Start date

2018-05-21

Completion date

2019-04-12

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

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.

Interventions

BEHAVIORALPhysical 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single arm cohort study with pre and post intervention assessments

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months	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 Behavioural Regulation In Exercise Questionnaire (BREQ-2)	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).

Secondary

Measure	Time frame	Description
Change From Baseline Brunel Lifestyle Inventory at 4 Months	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).
Change From Baseline Wechsler Adult Intelligence Scale -III (WAIS-III) Digit Span Forward and Backward at 4 Months	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.
Change From Baseline Stroop Color-Word Interference at 4 Months	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 Timed-up-and-go (TUG) at 4 Months	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 Exercise Self Efficacy Questionnaire at 4 Months	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.
Perceived Autonomy Support Healthcare Climate Questionnaire (HCCQ) at 4 Months	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.
Semi-Structured Post-intervention Questionnaire	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.
Change From Baseline Canadian Occupational Performance Measure (COPM) at 4 Months	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.
Change From Baseline 6 Minute Walk Test at 4 Months	baseline and 4 months	Assesses the distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Physical Activity Coaching Individuals received 6 sessions of physical activity coaching, delivered either in person or remotely via telehealth	13
Total	13

Baseline characteristics

Characteristic	Physical Activity Coaching
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	6 Participants
Age, Categorical Between 18 and 65 years	7 Participants
Age, Continuous	61.69 years STANDARD_DEVIATION 9.14
Hoehn & Yahr Stage 1	4 participants
Hoehn & Yahr Stage 2	9 participants
Montreal Cognitive Assessment	27 units STANDARD_DEVIATION 3
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	11 Participants
Region of Enrollment United States	13 participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	9 Participants
URICA-E2	10.7 units STANDARD_DEVIATION 4

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 13
other Total, other adverse events	0 / 13
serious Total, serious adverse events	0 / 13

Outcome results

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).