Title: A Multimodal Exercise Program With Gamification for Parkinson Disease (MEP+G)

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorCalifornia State University, Northridge

About this trial

In this pilot study the research will explore whether exercises and the outcome measures would be acceptable to conduct a more detailed research study. This 8 week pilot study will utilize a comprehensive exercise program that includes non-contact boxing along with computerized games for individuals with Parkinson Disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hoehn and Yahr stages 1-3 disease as determined by primary care physician, neurologist, or movement disorder specialist

diagnosis of idiopathic Parkinson's Disease

ability to ambulate with or without an assistive device

transportation to and from testing site

Disqualifiers

other neurological disease other than Parkinson's disease

having had deep brain stimulation within the past 3 months , as determined by their physician

currently participating in a Rock Steady boxing program

self-report participation in moderate to vigorous exercise greater than 60 minutes per week.

Trial design

Design model

Single group

Treatments tested in this trial

  • Multimodal Exercise Program with Gamification

    Other intervention

    A comprehensive exercise program for 3 days a week for 6 weeks that utilizes non-contact boxing and gamification at moderate to vigorous intensity.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Multimodal Exercise Program with GamificationExperimental treatment 1 intervention
Group B: Wait List ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Fidelity of intervention

Participants completing exercises as prescribed: measured using the daily exercise plan as a "yes" or "no".

Time frame
21 months
2

Intervention Adherence

Measured by daily exercise plan; instructors will indicate whether participant was present as a "yes" or "no"

Time frame
21 months
3

Feasibility of Outcomes

Retention: number of participants who completed the entire program divided by total number who started; x 100 to determine the percentage of participants who completed the program.

Time frame
21 months
4

Assessment of Data Collection

Data collection: measured using a pre-populated form and marked as a "yes" or "no" by the PI.

Time frame
21 months

Secondary outcomes

1

Balance

Measured via using the Mini Balance Evaluation System Test (Mini-BESTest): a series of subtests with a total score from 0-28 points; with a higher score indicating improved balance.

Time frame
21 months
2

Gait

Measured via Functional Gait Assessment (FGA): series of subtests based out of score from 0- 30 points; with a higher score indicating improved postural stability while walking.

Time frame
21 months
3

Physical Activity

Measured via International Physical Activity Questionnaire (IPAQ) based on minutes exercise per week with a higher number of minutes indicating increased physical activity

Time frame
21 months
4

Gait Speed

Gait speed measured via 10 meters divided by number of seconds to determine gait speed of meters per second (m/s); a increased in m/s indicating improved gait speed.

Time frame
21 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.