Trial · NCT03696589
Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease
NCT03696589, Phase 1, Phase 2, Completed, Teachers College, Columbia University; results first posted 2020-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease. Trials, record NCT03696589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03696589
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease
- NCT number
- NCT03696589
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Teachers College, Columbia University
- Conditions
- Parkinson's Disease
- Interventions
- Physical Activity Coaching
- First posted
- 2018-10-04
- Last updated
- 2020-09-16
- Results first posted
- 2020-09-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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 |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months | baseline and 4 months | percentage of time | MEAN | |
| PRIMARY | Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2) | baseline and 4 months | score on a scale | MEAN | |
| SECONDARY | Change From Baseline Timed-up-and-go (TUG) at 4 Months | baseline and 4 months | seconds | MEAN | |
| SECONDARY | Change From Baseline 6 Minute Walk Test at 4 Months | baseline and 4 months | meters | MEAN | |
| SECONDARY | Change From Baseline Brunel Lifestyle Inventory at 4 Months | baseline and 4 months | score on a scale | MEAN | |
| SECONDARY | Change From Baseline Wechsler Adult Intelligence Scale -III (WAIS-III) Digit Span Forward and Backward at 4 Months | baseline and 4 months | digits | MEAN | |
| SECONDARY | Change From Baseline Stroop Color-Word Interference at 4 Months | baseline and 4 months | correct words | MEAN | |
| SECONDARY | Change From Baseline Canadian Occupational Performance Measure (COPM) at 4 Months | baseline and 4 months | units on a scale | MEAN | |
| SECONDARY | Change From Baseline Exercise Self Efficacy Questionnaire at 4 Months | baseline and 4 months | score on a scale | MEAN | |
| SECONDARY | Perceived Autonomy Support Healthcare Climate Questionnaire (HCCQ) at 4 Months | 4 months | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months | Physical Activity Coaching - Pretest | %moderate-vigorous physical activity | 2.27 | Standard Deviation 1.83 | percentage of time |
| Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months | Physical Activity Coaching - Posttest | %moderate-vigorous physical activity | 3.16 | Standard Deviation 2.07 | percentage of time |
| Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months | Physical Activity Coaching - Pretest | %time sedentary | 76.96 | Standard Deviation 6.55 | percentage of time |
| Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months | Physical Activity Coaching - Posttest | %time sedentary | 75.74 | Standard Deviation 4.59 | percentage of time |
| Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2) | Physical Activity Coaching - Pretest | Controlled motivation | 1.28 | Standard Deviation 0.86 | score on a scale |
| Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2) | Physical Activity Coaching - Posttest | Controlled motivation | 1.56 | Standard Deviation 0.74 | score on a scale |
| Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2) | Physical Activity Coaching - Pretest | Autonomous motivation | 3.16 | Standard Deviation 0.68 | score on a scale |
| Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2) | Physical Activity Coaching - Posttest | Autonomous motivation | 3.23 | Standard Deviation 0.58 | score on a scale |
| Change From Baseline Timed-up-and-go (TUG) at 4 Months | Physical Activity Coaching Pretest | 7.34 | Standard Deviation 2.79 | seconds | |
| Change From Baseline Timed-up-and-go (TUG) at 4 Months | Physical Activity Coaching Posttest | 7.67 | Standard Deviation 1.50 | seconds |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Physical Activity Coaching | 13 | |
| Overall Study | COMPLETED | Physical Activity Coaching | 12 | |
| Overall Study | NOT COMPLETED | Physical Activity Coaching | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Physical Activity Coaching | 0 | 13 |
| Total, other adverse events | Physical Activity Coaching | 0 | 13 |
| Total, serious adverse events | Physical Activity Coaching | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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