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Behavioural Intervention

Exercise Program for Parkinson's Disease ((MEP+G) Trial)

Phase < 1

Recruiting

Led By Andrew S Bartlett, PhD

Research Sponsored by California State University, Northridge

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Diagnosis of idiopathic Parkinson's Disease

Must not have

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

Other neurological disease other than Parkinson's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a program involving boxing and computer games is a feasible and acceptable way to study the effects of exercise on individuals with Parkinson's Disease."

Who is the study for?

This trial is for individuals with Parkinson's Disease who are interested in participating in an 8-week exercise program that includes non-contact boxing and computerized games. The study aims to determine if these activities and outcome measures are acceptable for a more detailed future study.

What is being tested?

The intervention being tested is a multimodal exercise program combined with gamification elements, specifically designed for people with Parkinson's Disease. This pilot study will assess the feasibility of the exercises and their potential benefits over an 8-week period.

What are the potential side effects?

Since this trial involves physical exercise and computerized games, potential side effects may include muscle soreness, fatigue, or mild discomfort associated with physical activity. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's disease is in the early to mid-stages.

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I have been diagnosed with Parkinson's Disease.

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I can walk by myself or with help from a device.

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I can stand by myself for 10 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have undergone deep brain stimulation in the last 3 months.

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I have a neurological condition that is not Parkinson's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of Data Collection

Assessment of Participants Perception

Assessment of Safety

+3 more

Secondary study objectives

Balance

Cardiovascular Endurance

Disease Severity

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal Exercise Program with GamificationExperimental Treatment1 Intervention

The exercise program will be for 6 weeks, 3 days per week for 60 minutes per session and will consist of strengthening, balance, aerobic, flexibility, and use a computerized game to challenge thinking and reactions skills. The exercise program will also consist of non-contact boxing to improve strength, balance, and aerobic endurance. Each exercise session will be conducted by a licensed physical therapist. The format will consist of a 10-15-minute warm-up followed by 30 minutes of moderate to vigorous circuit training using boxing drills and a computerized game called SMARTfit. SMARTfit consists of a standing computer board that allows participants to touch, punch or kick it while playing a game. At the end of the 30 minutes, participants will complete a 10-15-minute cool-down consisting of core strengthening, posture training, and hip strengthening and stretching exercises. Participants will also be instructed to maintain their normal activities outside of the study intervention.

Group II: Wait List ControlActive Control1 Intervention

Participants randomly assigned to the wait list control group, will perform baseline testing and be instructed not to change their exercise habits. After 6 weeks participants will complete post-testing (described below) and be offered to be enrolled in the 6-week exercise group as described above. If participants decide to participate in the exercise group and still meet the inclusion and exclusion criteria, they will perform baseline testing, 6 weeks of exercise followed by another post-testing.

0 / 6Eligibility criteria met