N/A
N=44
Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT05421624 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Physical Activity Based on the Amount of Moderate Intensity Walking — 9.45; 16.17 minutes of moderate intensity walking
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Digital music therapeutic (Device); Active-Control (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boston University Charles River Campus
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Activity Based on the Amount of Moderate Intensity Walking |
6.85; 13.22 | — |
| PRIMARY Physical Activity Based on the Amount of Moderate Intensity Walking |
6.85; 13.22 | — |
| PRIMARY Physical Activity Based on the Amount of Moderate Intensity Walking |
6.85; 13.22 | — |
| PRIMARY Physical Activity Based on the Amount of Moderate Intensity Walking |
6.85; 13.22 | — |
| PRIMARY Step Activity Based on Daily Step Counts |
8407; 8284 | — |
| PRIMARY Step Activity Based on Daily Step Counts |
8407; 8284 | — |
| PRIMARY Step Activity Based on Daily Step Counts |
8407; 8284 | — |
| PRIMARY Step Activity Based on Daily Step Counts |
8407; 8284 | — |
| PRIMARY Gait Quality Based on Variability of Stride Time |
3.70; 3.05 | — |
| PRIMARY Gait Quality Based on Variability of Stride Time |
3.70; 3.05 | — |
| PRIMARY Gait Quality Based on Variability of Stride Time |
3.70; 3.05 | — |
| PRIMARY Self-Report Habit Index (SRHI) |
74.25; 57.85 | — |
| PRIMARY Self-Report Habit Index (SRHI) |
74.25; 57.85 | — |
| SECONDARY 10-Meter Walk Test (10MWT) - Comfortable Walking Speed |
1.18; 1.36 | — |
| SECONDARY 10-Meter Walk Test (10MWT) - Comfortable Walking Speed |
1.18; 1.36 | — |
| SECONDARY 10-Meter Walk Test (10MWT) - Comfortable Walking Speed |
1.18; 1.36 | — |
| SECONDARY 10-Meter Walk Test (10MWT) - Maximum Walking Speed |
1.80; 1.80 | — |
| SECONDARY 10-Meter Walk Test (10MWT) - Maximum Walking Speed |
1.80; 1.80 | — |
| SECONDARY 10-Meter Walk Test (10MWT) - Maximum Walking Speed |
1.80; 1.80 | — |
| SECONDARY 6-Minute Walk Test (6MWT) |
533.31; 570.98 | — |
| SECONDARY 6-Minute Walk Test (6MWT) |
533.31; 570.98 | — |
| SECONDARY 6-Minute Walk Test (6MWT) |
533.31; 570.98 | — |
| SECONDARY Gait Velocity During In-clinic Walking |
1.55; 1.63 | — |
| SECONDARY Gait Velocity During In-clinic Walking |
1.55; 1.63 | — |
| SECONDARY Gait Velocity During In-clinic Walking |
1.55; 1.63 | — |
| SECONDARY Stride Length During In-clinic Walking |
1.53; 1.56 | — |
| SECONDARY Stride Length During In-clinic Walking |
1.53; 1.56 | — |
| SECONDARY Stride Length During In-clinic Walking |
1.53; 1.56 | — |
| SECONDARY Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) |
22.86; 18.74 | — |
| SECONDARY Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) |
22.86; 18.74 | — |
| SECONDARY Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) |
22.86; 18.74 | — |
| SECONDARY Self-Efficacy of Walking - Duration (SEW-D) |
78.57; 76.89 | — |
| SECONDARY Self-Efficacy of Walking - Duration (SEW-D) |
78.57; 76.89 | — |
| SECONDARY Self-Efficacy of Walking - Duration (SEW-D) |
78.57; 76.89 | — |
| SECONDARY Geriatric Depression Scale (GDS) |
2.76; 2.53 | — |
| SECONDARY Geriatric Depression Scale (GDS) |
2.76; 2.53 | — |
| SECONDARY Geriatric Depression Scale (GDS) |
2.76; 2.53 | — |
| SECONDARY Parkinson's Disease Questionnaire - 39 (PDQ-39) |
12.34; 14.61 | — |
| SECONDARY Parkinson's Disease Questionnaire - 39 (PDQ-39) |
12.34; 14.61 | — |
| SECONDARY Parkinson's Disease Questionnaire - 39 (PDQ-39) |
12.34; 14.61 | — |
| SECONDARY Mini Balance Evaluation Systems Test (Mini BESTest) |
24.86; 26.00 | — |
| SECONDARY Mini Balance Evaluation Systems Test (Mini BESTest) |
24.86; 26.00 | — |
| SECONDARY Mini Balance Evaluation Systems Test (Mini BESTest) |
24.86; 26.00 | — |
Summary
Regular, habitual exercise is a critical component of the long-term management of Parkinson disease (PD). However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting moderate intensity walking activity -- an important health-objective in the management of PD. However, the therapeutic potential of RAS in self-directed walking programs has not been examined. In this pilot, we will utilize a breakthrough digital therapeutic that delivers music-adaptive RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. Habits are automatically recurring psychological dispositions that emerge from repeated behaviors. The investigators posit that music cues provide recurring contextual cues that automatically evoke habitual response of exercise, thus has the potential to prompt regular physical activity. This study will enroll 61individuals with mild-to-moderate PD (Run-in: 17; Main Trial: 44). The experimental intervention, "Amped-PD", is a 6-week, user-managed community-based walking program that utilizes music-adaptive RAS that progressively increases walking intensities. This study will examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking, and in improving motor deficits related to quality of walking in individuals with mild-to-moderate PD. This study will also examine whether the resultant habits formed from each intervention matter in relation to training-related changes in physical activity.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of idiopathic, typical Parkinson disease (based on the UK PD Society Brain Bank Criteria7) by a physician
- Modified Hoehn and Yahr stages 1-3 per physical exam by a licensed physical therapist
- 40 - 85 years of age
- Community-dwelling
- Able to walk independently without physical assistance or an assistive device for at least 10 minutes.
- Have stable PD medications for at least two weeks prior to enrollment.
- Willing and able to provide informed consent.
- Provide HIPAA Authorization to allow communication with the primary healthcare provider for communication (as needed) during the study period.
Exclusion Criteria
- 1 fall over the past 3 months
- Cognitive impairment (i.e., Mini-Mental State Exam Score (MMSE) 3x/week for 30 minutes per session.
- Cardiac conditions that may limit safe participation in exercise
- Orthopedic conditions that may limit safe participation in exercise
- Any other medical conditions that would preclude successful participation as determined by a physical therapist
Data sourced from ClinicalTrials.gov (NCT05421624). 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.