Mindfulness, Parkinson Disease
Conditions
Brief summary
The investigators will conduct an randomized controlled trial (RCT) among people with Parkinson disease (PD) and freezing of gait (FOG) to evaluate the feasibility of a mindfulness intervention compared to a educational program about FOG. FOG is a severe motor disturbance that prevents people from stepping normally and is associated with anxiety, frustration, sedentary behaviors, poorer quality of life, and falls. Mindfulness-Based Stress Reduction (MBSR) is an evidence-based practice that creates a culture to reduce stress and anxiety by increasing conscious awareness and self-compassion. In this study, the investigators will develop a mindfulness-based walking intervention to address both mental health and mobility challenges that constitute FOG.
Detailed description
Conduct pilot randomized clinical trial to evaluate feasibility and acceptability of the standardized Mindfulness Based Walking Therapy (MBWT) program. Using the standardized MBWT protocol devised during earlier aims of this study, the investigators will randomize 24 people with PD+FOG to MBWT or FOG education (i.e., usual care and FOG education), examining feasibility elements.
Interventions
BEHAVIORALMindfulness Based Walking Therapy (MBWT)
MBWT is a modified version of the Mindfulness Based Stress Reduction (MBSR) program that incorporates more walking mediations and is acceptable for people with Parkinson disease and freezing of gait.
OTHERFreezing of Gait (FOG) Education
Participants will receive materials to read weekly about FOG and track their usual care regimens.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosed by a neurologist with idiopathic Parkinson disease; * age 50 and older; * a score on the Hoehn & Yahr (H&Y) scale between I-IV; * history of freezing of gait; * able to provide informed consent; * experience fear or worry in relation to their freezing of gait; * able to walk independently with or without an assistive device for at least five minutes; and * stable medication regimen for one month prior to enrollment.
Exclusion criteria
* have evidence of dementia (Montreal Cognitive Assessment (MOCA) - Telephone Version \< 13) to ensure understanding of materials; * are under consideration for deep brain stimulation surgery within the next six months; neurologic condition other than PD; * inability to cooperate with the protocol; * language, visual, or hearing barriers to participation; or * history of orthopedic or other medical problems that limit ability to participate safely in the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment of Sample: Number of Participants Recruited | 14 weeks | The investigators will count the number of participants recruited to determine if the feasibility objective of recruitment is met. The investigators benchmark for recruitment is defined as recruiting a target sample of 24 participants to randomize. |
| Attendance of Participants: Average Number of Participants at Each Session | 14 weeks | The investigators will count the number of enrolled participants who were in attendance at each mindfulness session and report the average percentage of participants that attended each mindfulness session over the course of the study to determine if the feasibility objective of attendance is met. The investigators benchmark for attendance is defined as at least 80% of participants attending each session. The number of sessions was 14, we then counted the number of enrolled participants who attended at each session and then averaged that number across the sessions. The unit of measure represents the average number of participants. |
| Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More | 14 weeks | The investigators will count the number of participants who attended 11 or more of the 14 sessions (80% of the sessions). Benchmark: Retention is defined as at least 80% of participants attending 80% of the sessions. |
| Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home | 12 weeks | The investigators will ask participants to track the number of hours spent practicing mindfulness at home to determine if the feasibility objective of adherence is met. The investigators benchmark for adherence is as completing 70% of daily home assignment hours. No homework assignments after class 12 (class 13 was the retreat). |
Countries
United States
Participant flow
Recruitment details
Recruitment began in May 2023 and concluded in August 2023. Recruitment locations included recruitment flyers at physical therapy and movement disorder clinics, health fairs and events, and support groups.
Pre-assignment details
We consented people via an online format and conducted phone interview screening prior to in-person evaluations. Participants were excluded after the phone interview if they had significant cognitive impairment (MOCA-Telephone Version \<13, noted they were not diagnosed with idiopathic Parkinson disease, or could not walk more than five minutes.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-Based Walking Therapy (MBWT) Participants will receive the MBWT intervention. | 12 |
| Freezing of Gait (FOG) Education Participants will receive educational materials about FOG and track their usual care. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Health related | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Mindfulness-Based Walking Therapy (MBWT) | Freezing of Gait (FOG) Education | Total |
|---|---|---|---|
| Age, Continuous | 69.17 years of age STANDARD_DEVIATION 8.45 | 69.83 years of age STANDARD_DEVIATION 7.33 | 69.50 years of age STANDARD_DEVIATION 7.75 |
| New Freezing of Gait Questionnaire (N-FOG) | 18.08 units on a scale STANDARD_DEVIATION 4.87 | 18.58 units on a scale STANDARD_DEVIATION 4.81 | 18.33 units on a scale STANDARD_DEVIATION 4.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home
The investigators will ask participants to track the number of hours spent practicing mindfulness at home to determine if the feasibility objective of adherence is met. The investigators benchmark for adherence is as completing 70% of daily home assignment hours. No homework assignments after class 12 (class 13 was the retreat).
Time frame: 12 weeks
Population: Only 5 of the 7 participants who did not withdraw and 1 participant who did withdraw submitted tracking forms for 6 or more weeks.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness-Based Walking Therapy (MBWT) | Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home | 89.54 percentage of home assignment hours |
Primary
Attendance of Participants: Average Number of Participants at Each Session
The investigators will count the number of enrolled participants who were in attendance at each mindfulness session and report the average percentage of participants that attended each mindfulness session over the course of the study to determine if the feasibility objective of attendance is met. The investigators benchmark for attendance is defined as at least 80% of participants attending each session. The number of sessions was 14, we then counted the number of enrolled participants who attended at each session and then averaged that number across the sessions. The unit of measure represents the average number of participants.
Time frame: 14 weeks
Population: 7 participants who did not withdraw from the 14 week program and 5 participants who withdrew (1 after session 1, 1 after session 2, 1 after session 4, 1 after session 5, 1 after session 7)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness-Based Walking Therapy (MBWT) | Attendance of Participants: Average Number of Participants at Each Session | 88.46 percentage of participants |
Primary
Recruitment of Sample: Number of Participants Recruited
The investigators will count the number of participants recruited to determine if the feasibility objective of recruitment is met. The investigators benchmark for recruitment is defined as recruiting a target sample of 24 participants to randomize.
Time frame: 14 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-Based Walking Therapy (MBWT) | Recruitment of Sample: Number of Participants Recruited | 12 Participants |
| Freezing of Gait (FOG) Education | Recruitment of Sample: Number of Participants Recruited | 12 Participants |
Primary
Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More
The investigators will count the number of participants who attended 11 or more of the 14 sessions (80% of the sessions). Benchmark: Retention is defined as at least 80% of participants attending 80% of the sessions.
Time frame: 14 weeks
Population: 12 participants (7 participants who did not withdraw and 5 participant who withdrew)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-Based Walking Therapy (MBWT) | Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More | 6 Participants |