Freezing of Gait, Parkinson Disease
Conditions
Keywords
Mindfulness
Brief summary
The investigators will modify and evaluate the feasibility of a mindfulness intervention among people living with Parkinson disease (PD) and freezing of gait (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. This R34 feasibility study includes three aims to permit the development of a mind and body approach for FOG among people living with PD.
Detailed description
Aim 1: Create a Mindfulness-Based Walking Therapy (MBWT) program by modifying the MBSR standard protocol based upon feedback from an advisory group. An advisory group consisting of physical therapists, mindfulness instructors, research team members, 3-5 people with PD+FOG and care partners will modify the standard MBSR program over a twelve-week period to make it acceptable and feasible for people with PD+FOG and shift the focus from sitting, standing, or lying meditations to walking mediations. Aim 2: Refine and standardize the MBWT protocol to ensure feasibility and acceptability through open pilot testing. Twelve participants with PD+FOG will participate in an open pilot of the MBWT program. The MBWT program will then be modified based on participant feedback to produce a standardized MBWT to use in Aim 3. Feasibility elements include meeting benchmarks for: 1) recruitment and randomization; 2) retention and satisfaction; 3) delivery of the intervention; 4) participant adherence using technology; 5) evaluating clarity and burden of outcome assessments; and 6) monitoring adverse events. Aim 3: Conduct pilot randomized clinical trial to evaluate feasibility and acceptability of the standardized MBWT program. Using the standardized MBWT protocol produced from Aim 2, the investigators will randomize 24 people with PD+FOG to MBWT or usual care (i.e., medical management and FOG education), examining feasibility elements listed in Aim 2. The investigators will also conduct follow-up evaluations to monitor burden and continued usage of mindfulness. Aim 3 is under NCT05923229.
Interventions
BEHAVIORALMindfulness Based Walking Therapy (MBWT)
MBWT will be a modified form of the typical Mindfulness Based Stress Reduction (MBSR) program that incorporates more walking meditations and is acceptable for people with Parkinson disease and freezing of gait.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In Aim 2, participants will receive the mindfulness intervention as part of the open pilot.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosed by a neurologist with idiopathic Parkinson disease; * age 55 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 two months prior to enrollment.
Exclusion criteria
* have evidence of dementia (Montreal Cognitive Assessment (MOCA) \< 18) 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 12 participants. |
| Attendance of Participants: Average Percentage of Participants at Each Session | 14 weeks | The investigators will count the number of participants at each session and report the average percentage of participants that attended each 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. |
| Retention of Participants: Average Percentage of Sessions Each Participant Completes | 14 weeks | The investigators will count the number of sessions each participant attends and report the number of classes each participant attended on average to determine if the feasibility objective of retention is met. The investigators benchmark for retention is defined as participants attending 80% of the sessions. |
| Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home | 14 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 defined as participants completing 70% of daily home assignment hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MBWT Mindfulness-Based Walking Therapy Program | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | MBWT |
|---|---|
| Age, Continuous | 70.44 years STANDARD_DEVIATION 8.3 |
| New Freezing of Gait Questionnaire | 16.78 units on a scale STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 1 / 9 |
| serious Total, serious adverse events | 0 / 9 |
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 defined as participants completing 70% of daily home assignment hours.
Time frame: 14 weeks
Population: Only five participants regularly reported home assignment hours.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MBWT | Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home | 147.84 percentage of home assignment hours |
Primary
Attendance of Participants: Average Percentage of Participants at Each Session
The investigators will count the number of participants at each session and report the average percentage of participants that attended each 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.
Time frame: 14 weeks
Population: 7 participants completed the 14 week program, 2 participants withdrew after class 5
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MBWT | Attendance of Participants: Average Percentage of Participants at Each Session | 79.82 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 12 participants.
Time frame: 14 weeks
Population: Twelve participants were recruited and signed a consent form. Three participants did not pass in-person screening resulting in nine participants who started the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBWT | Recruitment of Sample: Number of Participants Recruited | 12 Participants |
Primary
Retention of Participants: Average Percentage of Sessions Each Participant Completes
The investigators will count the number of sessions each participant attends and report the number of classes each participant attended on average to determine if the feasibility objective of retention is met. The investigators benchmark for retention is defined as participants attending 80% of the sessions.
Time frame: 14 weeks
Population: 7 participants who completed the 14 week program and 2 participants who withdrew after class 5
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MBWT | Retention of Participants: Average Percentage of Sessions Each Participant Completes | 78.25 percentage of classes attended |