Clinical trial NCT05309083: Moving Mindfully for Freezing in Parkinsons
Official title: Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait
Keywords: Mindfulness
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 9
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In Aim 2, participants will receive the mindfulness intervention as part of the open pilot.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment of Sample: Number of Participants Recruited
timeFrame: 14 weeks
measure: Attendance of Participants: Average Percentage of Participants at Each Session
timeFrame: 14 weeks
measure: Retention of Participants: Average Percentage of Sessions Each Participant Completes
timeFrame: 14 weeks
measure: Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine Program in Physical Therapy
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Gammon Earhart, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Kerri Rawson, PhD
role: PRINCIPAL_INVESTIGATOR
References: