Trial Outcomes & Findings for Moving Mindfully for Freezing in Parkinsons (NCT NCT05309083)

Last Updated: 2024-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

14 weeks

Results posted on

2024-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Mindfulness Based Walking Therapy (MBWT) Participants will participate in MBWT. Mindfulness 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.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Mindfulness Based Walking Therapy (MBWT) Participants will participate in MBWT. Mindfulness 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.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Moving Mindfully for Freezing in Parkinsons

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MBWT n=9 Participants Mindfulness-Based Walking Therapy Program
Age, Continuous	70.44 years STANDARD_DEVIATION 8.3 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
New Freezing of Gait Questionnaire	16.78 units on a scale STANDARD_DEVIATION 6.1 • n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MBWT n=12 Participants Mindfulness-Based Walking Therapy
Recruitment of Sample: Number of Participants Recruited	12 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: 7 participants completed the 14 week program, 2 participants withdrew after class 5

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.

Outcome measures

Outcome measures
Measure	MBWT n=9 Participants Mindfulness-Based Walking Therapy
Attendance of Participants: Average Percentage of Participants at Each Session	79.82 percentage of participants Interval 55.56 to 100.0

PRIMARY outcome

Timeframe: 14 weeks

Population: 7 participants who completed the 14 week program and 2 participants who withdrew after class 5

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.

Outcome measures

Outcome measures
Measure	MBWT n=9 Participants Mindfulness-Based Walking Therapy
Retention of Participants: Average Percentage of Sessions Each Participant Completes	78.25 percentage of classes attended Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: 14 weeks

Population: Only five participants regularly reported home assignment hours.

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.

Outcome measures

Outcome measures
Measure	MBWT n=5 Participants Mindfulness-Based Walking Therapy
Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home	147.84 percentage of home assignment hours Interval 23.0 to 325.0

Adverse Events

MBWT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MBWT n=9 participants at risk Mindfulness-Based Walking Therapy
General disorders Fall	11.1% 1/9 • Number of events 1 • Adverse Events were collected during baseline evaluations (1-4 weeks prior), the 14 week intervention, post evaluations (1-4 weeks post intervention) and follow-up evaluations (12-16 weeks after post); on average 38 weeks.

Additional Information

Dr. Kerri Rawson

Washington University School of Medicine

Phone: 813-468-8900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place