Phase 2
N=13
Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03696589 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months — 2.27; 3.16; 76.96; 75.74 percentage of time
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Physical Activity Coaching (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teachers College, Columbia University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months |
2.27; 3.16; 76.96; 75.74 | — |
| PRIMARY Change From Baseline in the Behavioural Regulation In Exercise Questionnaire (BREQ-2) |
1.28; 1.56; 3.16; 3.23 | — |
| SECONDARY Change From Baseline Timed-up-and-go (TUG) at 4 Months |
7.34; 7.67 | — |
| SECONDARY Change From Baseline 6 Minute Walk Test at 4 Months |
461.42; 442.96 | — |
| SECONDARY Change From Baseline Brunel Lifestyle Inventory at 4 Months |
3.79; 4.14; 2.31; 2.56 | — |
| SECONDARY Change From Baseline Wechsler Adult Intelligence Scale -III (WAIS-III) Digit Span Forward and Backward at 4 Months |
10.33; 11.27 | — |
| SECONDARY Change From Baseline Stroop Color-Word Interference at 4 Months |
38.42; 40.50 | — |
| SECONDARY Change From Baseline Canadian Occupational Performance Measure (COPM) at 4 Months |
4.99; 8.08; 5.75; 8.33 | — |
| SECONDARY Change From Baseline Exercise Self Efficacy Questionnaire at 4 Months |
61.92; 67.42 | — |
| SECONDARY Perceived Autonomy Support Healthcare Climate Questionnaire (HCCQ) at 4 Months |
6.69 | — |
| SECONDARY Semi-Structured Post-intervention Questionnaire |
4.35 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03696589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.