Design of the WHIP-PD study: a phase II, twelve-month, dual-site, randomized controlled trial evaluating the effects of a cognitive-behavioral approach for promoting enhanced walking activity using mobile health technology in people with Parkinson-disease.
Study Goal
The researchers aimed to determine whether a "connected behavioral approach" combining cognitive-behavioral training and mHealth technology could increase real-world walking activity and improve walking capacity in individuals with early to mid-stage Parkinson's disease.
Results Summary
The study expects the connected behavioral approach to be more effective than the active control condition in increasing the amount and intensity of real-world walking activity and improving walking capacity, though final results are pending as the study is ongoing.
Population
Individuals with early to mid-stage Parkinson's disease (148 participants).
Effective Dosage
Not specified (customized program of goal-oriented walking and strengthening exercises).
Duration
Twelve months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
connected behavioral approach (cognitive-behavioral training and mobile health (mHealth) technology) | increase | amount and intensity of real-world walking activity | participants with early to mid-stage Parkinson disease (PD) | - | will be more effective than the active control condition in increasing | #1 |
connected behavioral approach (cognitive-behavioral training and mobile health (mHealth) technology) | increase | walking capacity | participants with early to mid-stage Parkinson disease (PD) | - | will be more effective than the active control condition in improving | #2 |
connected behavioral approach (cognitive-behavioral training and mobile health (mHealth) technology) | neutral | - | participants with early to mid-stage Parkinson disease (PD) | - | will be more effective than the active control condition | #3 |
connected behavioral condition (includes cognitive-behavioral training and mHealth software application) | neutral | cognitive-behavioral training to promote self-efficacy for routine walking behavior | participants with early to mid-stage Parkinson disease (PD) | - | will receive | #4 |
connected behavioral condition (includes cognitive-behavioral training and mHealth software application) | neutral | mHealth software application to manage their program and communicate remotely with their physical therapist | participants with early to mid-stage Parkinson disease (PD) | - | will use | #5 |
active control condition (no cognitive-behavioral training, manage program on paper) | no change | cognitive-behavioral training | participants with early to mid-stage Parkinson disease (PD) | - | will receive no | #6 |
customized program of goal-oriented walking, walking-enhancing strengthening exercises, and eight in-person visits with a physical therapist | neutral | - | participants with early to mid-stage Parkinson disease (PD) | - | will include | #7 |
Walking and mHealth to Increase Participation in Parkinson Disease (WHIP-PD) study | neutral | self-efficacy mediates change in amount of walking activity | participants with early to mid-stage Parkinson disease (PD) | - | will examine if | #8 |
Walking and mHealth to Increase Participation in Parkinson Disease (WHIP-PD) study | neutral | change in amount of walking activity mediates change in walking capacity | participants with early to mid-stage Parkinson disease (PD) | - | will examine if | #9 |
BACKGROUND: Parkinson disease (PD) is a debilitating and chronic neurodegenerative disease resulting in ambulation difficulties. Natural walking activity often declines early in disease progression despite the relative stability of motor impairments. In this study, we propose a paradigm shift with a "connected behavioral approach" that targets real-world walking using cognitive-behavioral training and mobile health (mHealth) technology. METHODS/DESIGN: The Walking and mHealth to Increase Participation in Parkinson Disease (WHIP-PD) study is a twelve-month, dual site, two-arm, randomized controlled trial recruiting 148 participants with early to mid-stage PD. Participants will be randomly assigned to connected behavioral or active control conditions. Both conditions will include a customized program of goal-oriented walking, walking-enhancing strengthening exercises, and eight in-person visits with a physical therapist. Participants in the connected behavioral condition also will (1) receive cognitive-behavioral training to promote self-efficacy for routine walking behavior and (2) use a mHealth software application to manage their program and communicate remotely with their physical therapist. Active control participants will receive no cognitive-behavioral training and manage their program on paper. Evaluations will occur at baseline, three-, six-, and twelve-months and include walking assessments, self-efficacy questionnaires, and seven days of activity monitoring. Primary outcomes will include the change between baseline and twelve months in overall amount of walking activity (mean number of steps per day) and amount of moderate intensity walking activity (mean number of minutes per day in which > 100 steps were accumulated). Secondary outcomes will include change in walking capacity as measured by the six-minute walk test and ten-meter walk test. We also will examine if self-efficacy mediates change in amount of walking activity and if change in amount of walking activity mediates change in walking capacity. DISCUSSION: We expect this study to show the connected behavioral approach will be more effective than the active control condition in increasing the amount and intensity of real-world walking activity and improving walking capacity. Determining effective physical activity interventions for persons with PD is important for preserving mobility and essential for maintaining quality of life. Clinical trials registration NCT03517371, May 7, 2018. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03517371. Date of registration: May 7, 2018. Protocol version: Original.