Trial Outcomes & Findings for Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease (NCT NCT03696589)

NCT ID: NCT03696589

Last Updated: 2020-09-16

Results Overview

Measured using Actigraph accelerometer, levels of moderate-vigorous physical activity will be measured, as well as number of steps and sedentary behavior.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: baseline and 4 months
• Results posted on: 2020-09-16

Participant Flow

Participant milestones

Measure	Physical Activity Coaching Individuals received 6 sessions of physical activity coaching, delivered either in person or remotely via telehealth
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Physical Activity Coaching n=13 Participants Individuals received 6 sessions of physical activity coaching, delivered either in person or remotely via telehealth
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	61.69 years STANDARD_DEVIATION 9.14 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Hoehn & Yahr Stage 1	4 participants n=5 Participants
Hoehn & Yahr Stage 2	9 participants n=5 Participants
Montreal Cognitive Assessment	27 units STANDARD_DEVIATION 3 • n=5 Participants
URICA-E2	10.7 units STANDARD_DEVIATION 4.0 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months %moderate-vigorous physical activity	2.27 percentage of time Standard Deviation 1.83	3.16 percentage of time Standard Deviation 2.07
Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months %time sedentary	76.96 percentage of time Standard Deviation 6.55	75.74 percentage of time Standard Deviation 4.59

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2) Controlled motivation	1.28 score on a scale Standard Deviation 0.86	1.56 score on a scale Standard Deviation 0.74
Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2) Autonomous motivation	3.16 score on a scale Standard Deviation 0.68	3.23 score on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline Timed-up-and-go (TUG) at 4 Months	7.34 seconds Standard Deviation 2.79	7.67 seconds Standard Deviation 1.50

SECONDARY outcome

Timeframe: baseline and 4 months

Assesses the distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline 6 Minute Walk Test at 4 Months	461.42 meters Standard Deviation 79.22	442.96 meters Standard Deviation 87.61

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline Brunel Lifestyle Inventory at 4 Months Planned physical activity	3.79 score on a scale Standard Deviation 0.78	4.14 score on a scale Standard Deviation 0.77
Change From Baseline Brunel Lifestyle Inventory at 4 Months Unplanned physical activity	2.31 score on a scale Standard Deviation 0.67	2.56 score on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline Wechsler Adult Intelligence Scale -III (WAIS-III) Digit Span Forward and Backward at 4 Months	10.33 digits Standard Deviation 3.31	11.27 digits Standard Deviation 2.83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline Stroop Color-Word Interference at 4 Months	38.42 correct words Standard Deviation 10.31	40.50 correct words Standard Deviation 10.72

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline Canadian Occupational Performance Measure (COPM) at 4 Months Performance	4.99 units on a scale Standard Deviation 1.89	8.08 units on a scale Standard Deviation 0.89
Change From Baseline Canadian Occupational Performance Measure (COPM) at 4 Months Satisfaction	5.75 units on a scale Standard Deviation 1.09	8.33 units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Physical Activity Coaching - Pretest n=13 Participants Baseline Pretest	Physical Activity Coaching - Posttest n=12 Participants 4 month posttest
Change From Baseline Exercise Self Efficacy Questionnaire at 4 Months	61.92 score on a scale Standard Deviation 16.89	67.42 score on a scale Standard Deviation 13.04

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Physical Activity Coaching - Pretest n=12 Participants Baseline Pretest	Physical Activity Coaching - Posttest 4 month posttest
Perceived Autonomy Support Healthcare Climate Questionnaire (HCCQ) at 4 Months	6.69 score on a scale Standard Deviation 0.46	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Physical Activity Coaching - Pretest n=12 Participants Baseline Pretest	Physical Activity Coaching - Posttest 4 month posttest
Semi-Structured Post-intervention Questionnaire	4.35 units on a scale Standard Deviation 0.27	—

Adverse Events

Physical Activity Coaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lori Quinn

Teachers College, Columbia University

Phone: 212-678-3424

Email: lq2165@tc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place