Parkinson Disease
Conditions
Keywords
Parkinson disease, Walking, Exercise, Mobile Health, Physical Therapy, Cognitive Behavioral
Brief summary
Identifying effective ways to improve function, slow decline and reduce disability is a high priority for people living with Parkinson disease and other chronic conditions. Regular participation in walking is essential to reduce disability and enhance participation in preferred life activities. However, people with chronic conditions are often sedentary, contributing to greater disability. The goal of this work is to determine the benefits of a walking, walking enhancing exercises and cognitive-behavioral strategies delivered using mobile health technology for people with Parkinson disease over a sustained period of time.
Detailed description
Parkinson disease (PD) is one of the most disabling chronic health conditions affecting older adults globally. While advances in medical and surgical management of PD have increased lifespans, these have not effectively altered the progressive decline in physical function and quality of life associated with PD. Identifying effective ways to improve function, slow decline and prevent or reduce disability remains of utmost importance in PD. Of particular concern in PD is gait decline, which is considered a red flag signaling emerging disability. Prior work has shown that people with PD experienced a 12% decline in amount of walking over one year - despite relative stability of motor impairments during that year. Treatment targeting walking, the most rapidly changing aspect of disability in PD, may have the greatest influence on slowing the impact of disease progression on physical function and reducing disability. Traditionally, rehabilitation has targeted impairments and functional limitations with the expectation that gains would translate into greater participation in real-world activities. However, the evidence suggests that this does not occur. In this proposal, the investigators suggest a paradigm shift in which the primary target of the intervention is real-world walking behavior, as greater walking activity could preserve walking function and slow disability. The primary factors that limit engagement in walking in PD are psychological (e.g., low self-efficacy) rather than physical (e.g., motor impairments) in nature. As such, investigators will evaluate a cognitive-behavioral approach, grounded in social-cognitive theory and targeted at enhancing walking activity. This connected behavioral approach links physical therapists to persons with PD using a mobile health (mHealth) platform to deliver strategies to increase self-efficacy and provide goal-oriented, dynamic walking routines and walking enhancing exercises over one year. This approach will be compared to a control intervention which provides equivalent components and dosing of walking and a walking enhancing exercise program delivered by physical therapists but without a cognitive-behavioral mHealth approach. Investigators hypothesize that the mHealth group will demonstrate higher amounts of walking activity and greater walking capacity relative to the control group. With regard to mechanism underlying improvements in the mHealth group, it is hypothesized that self-efficacy will mediate changes in amount of walking and that changes in amount of walking will mediate changes in walking capacity over one year. The insights to be gained regarding mechanisms underlying changes noted will be critical to inform rehabilitation interventions designed to encourage sustained, long-term physical activity. If effective, our connected behavioral approach offers a unique, generalizable and scalable means to increase walking activity and improve walking capacity, thereby reducing disability in PD and perhaps in other chronic progressive conditions.
Interventions
OTHERmHealth delivered exercise program
Participants in the mobile health condition have up to 8 in-person visits with a physical therapist over 12 months. The exercise program, consisting of walking, strengthening and stretching exercises, is prescribed through an app and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week.
OTHERExercise only
Participants in the control group have up to 8 in-person visits with the intervention physical therapist over 12-months. Participants are instructed by the physical therapist to engage in walking and perform progressive resistance and stretching exercises (tailored to their needs and provided in written format) 5 days per week.
Sponsors
Washington University School of Medicine
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded assessors will administer standardizes outcome measures across sites (BU & WU)
Intervention model description
This study will take place at Boston University (BU) and Washington University in St. Louis (WU). This is a two-arm, single-blinded, 1-year randomized controlled trial. Persons with mild to moderate PD are randomly assigned to one of two treatment arms. In the mHealth arm, individuals participate in a cognitive-behavioral community-based walking program plus home-based walking enhancing progressive resistance exercises delivered using a mobile health platform. The active control condition receives the same components and dose of walking and exercise but without a cognitive-behavioral approach or the use of mobile health technology.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria; 2. Hoehn & Yahr stages 1-3 (mild to moderate disease severity); 3. Stable on all PD medications for at least 2 weeks prior to study entry; 4. Willing and able to provide informed consent.
Exclusion criteria
1. \< 18 years of age; 2. Pregnant; 3. diagnosis of atypical Parkinsonism; 4. Hoehn & Yahr stages 4-5 5. a score of \> 2 on item 7 of the new freezing of gait questionnaire (moderately or significantly disturbing freezing episodes during daily walking); 6. significant cognitive impairment; 7. unstable medical or concomitant illnesses or psychiatric conditions, which in the opinion of the investigators would preclude successful participation; 8. cardiac problems that interfere with ability to safely exercise 9. orthopedic problems in the lower extremities or spine that may limit walking distance; 10. unable to walk for 10 continuous minutes independently; 11. live in an institution or medical facility (i.e. not in the community)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Activity | 12 months | Change in the average number of steps walked per day over the one year study. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Daily steps were averaged at baseline and 12-month and a change score was computed (average of daily steps at 12-Months minus average of daily steps at baseline). |
| Walking Intensity | 12 months | Change in the average number of moderate intensity minutes over the one year study. Moderate intensity minutes is defined as the number of minutes in which \>100 steps were accumulated. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Moderate intensity minutes were averaged at baseline and 12-month and a change score was computed (average of moderate intensity minutes at 12-Months minus average of moderate intensity minutes at baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking Capacity - Six Minute Walk Distance | 12 months | Change in the number of meters walked during the six-minute walk test over the one year study. The distance in meters is reported. Participants completed the six-minute walk before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters walked at 12 months minus the number of meters walked at baseline). |
| Walking Capacity - Ten Meter Walk Test | 12 months | Change in the number of meters per second walked during the ten-meter walk test (comfortable forward pace) over the one year study. The distance in meters per second are reported. Participants completed the ten-meter walk test before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters per second walked at 12-months minus the number of meters per second walked at baseline). |
Countries
United States
Participant flow
Recruitment details
Recruitment began in February 2019 and concluded in March 2023. We experienced pauses in recruiting new participants during COVID 2020-2021. For already enrolled participants, we continued collection of measures that could be done remotely. Recruitment was via flyers which were available at physical therapy clinics, movement disorder clinics, support groups, and health fairs and events.
Pre-assignment details
Participants were excluded during in-person screening if they had significant cognitive impairment (Mini-Mental Status Examination \< 24), disturbing freezing of gait episodes during daily walking (score of ≥ 2 on item 7 of New Freezing of Gait Questionnaire, resting tachycardia (\>120 beats/min), uncontrolled BP (resting systolic BP\>180 mmHg or diastolic BP\>100 mmHg)), unstable medical illnesses or conditions that would preclude successful participation, and/or Modified Hoehn & Yahr stage \>3.
Participants by arm
| Arm | Count |
|---|---|
| mHealth Delivered Exercise Program Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application (app). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature. | 73 |
| Exercise Only Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided. | 67 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 9 |
| Overall Study | COVID restrictions | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Not idiopathic Parkinson's disease | 0 | 3 |
| Overall Study | Receiving DBS Surgery | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | mHealth Delivered Exercise Program | Exercise Only | Total |
|---|---|---|---|
| Age, Continuous | 68.25 age, continuous, in years STANDARD_DEVIATION 8.37 | 67.21 age, continuous, in years STANDARD_DEVIATION 7.79 | 67.75 age, continuous, in years STANDARD_DEVIATION 8.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants | 67 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 63 Participants | 132 Participants |
| Sex: Female, Male Female | 33 Participants | 32 Participants | 65 Participants |
| Sex: Female, Male Male | 40 Participants | 35 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 67 |
| other Total, other adverse events | 39 / 73 | 35 / 67 |
| serious Total, serious adverse events | 15 / 73 | 17 / 67 |
Outcome results
Primary
Walking Activity
Change in the average number of steps walked per day over the one year study. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Daily steps were averaged at baseline and 12-month and a change score was computed (average of daily steps at 12-Months minus average of daily steps at baseline).
Time frame: 12 months
Population: There were 15 participants who withdrew in mHealth group and 19 participant who withdrew in the exercise group. In addition, one participant was missing daily step data at random at 12 months in mHealth, and one participant was missing data due to a technical issue with the step watch in the exercise group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mHealth Delivered Exercise Program | Walking Activity | -207.59 change in average daily steps | Standard Deviation 2749.39 |
| Exercise Only | Walking Activity | -135.24 change in average daily steps | Standard Deviation 2403.17 |
p-value: 0.8995% CI: [-943.34, 1088.04]t-test, 2 sided
Primary
Walking Intensity
Change in the average number of moderate intensity minutes over the one year study. Moderate intensity minutes is defined as the number of minutes in which \>100 steps were accumulated. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Moderate intensity minutes were averaged at baseline and 12-month and a change score was computed (average of moderate intensity minutes at 12-Months minus average of moderate intensity minutes at baseline).
Time frame: 12 months
Population: There were 15 participants who withdrew in mHealth group and 19 participant who withdrew in the exercise group. In addition, one participant was missing daily step data at random at 12 months in mHealth, and one participant was missing data due to a technical issue with the step watch in the exercise group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mHealth Delivered Exercise Program | Walking Intensity | 1.67 change in average moderate intensity min | Standard Deviation 9.41 |
| Exercise Only | Walking Intensity | 1.33 change in average moderate intensity min | Standard Deviation 8.07 |
p-value: 0.4295% CI: [-3.8, 3.1]t-test, 2 sided
Secondary
Walking Capacity - Six Minute Walk Distance
Change in the number of meters walked during the six-minute walk test over the one year study. The distance in meters is reported. Participants completed the six-minute walk before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters walked at 12 months minus the number of meters walked at baseline).
Time frame: 12 months
Population: There were 15 participants who withdrew in the mHealth group and 19 participants who withdrew in the exercise group. Due to COVID restrictions, we were unable to complete measures that required participants to come in-person, thus we are missing data on this measure for 17 more people in the mHealth group and 19 more people in the exercise group. In addition, one participant in mHealth and one participant in exercise group did not complete this measure at 12-month due to physical reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mHealth Delivered Exercise Program | Walking Capacity - Six Minute Walk Distance | 15.63 change in meters walked | Standard Deviation 57.02 |
| Exercise Only | Walking Capacity - Six Minute Walk Distance | 17.79 change in meters walked | Standard Deviation 37.12 |
p-value: 0.8595% CI: [-20.64, 24.97]t-test, 2 sided
Secondary
Walking Capacity - Ten Meter Walk Test
Change in the number of meters per second walked during the ten-meter walk test (comfortable forward pace) over the one year study. The distance in meters per second are reported. Participants completed the ten-meter walk test before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters per second walked at 12-months minus the number of meters per second walked at baseline).
Time frame: 12 months
Population: There were 15 participants who withdrew in the mHealth group and 19 participants who withdrew in the exercise group. Due to COVID restrictions, we were unable to complete measures that required participants to come in-person, thus we are missing data on this measure for 17 more people in the mHealth group and 19 more people in the exercise group. In addition, one participant in mHealth did not complete this measure at 12 months due to physical reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mHealth Delivered Exercise Program | Walking Capacity - Ten Meter Walk Test | .027 change in meters per second | Standard Deviation 0.146 |
| Exercise Only | Walking Capacity - Ten Meter Walk Test | .019 change in meters per second | Standard Deviation 0.154 |
p-value: 0.82495% CI: [-0.081, 0.065]t-test, 2 sided