Clinical trial NCT05923229: Moving Mindfully for Freezing of Gait
Official title: Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease - Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Mindfulness
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment of Sample: Number of Participants Recruited
timeFrame: 14 weeks
measure: Attendance of Participants: Average Number of Participants at Each Session
timeFrame: 14 weeks
measure: Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More
timeFrame: 14 weeks
measure: Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Gammon Earhart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Kerri Rawson, PhD
role: PRINCIPAL_INVESTIGATOR
References: