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

NCT06538298 | Recruiting Early Phase 1

• 1 other identifier: IRB-FY24-23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Multimodal Exercise; Gamification; Parkinson's Disease

Outcome Measures

Primary Outcomes (6)

• Fidelity of intervention

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

  21 months

• Intervention Adherence

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

  21 months

• 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.

  21 months

• Assessment of Data Collection

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

  21 months

• Assessment of Safety

  Adverse events (i.e., falls): measured by the daily exercise plan as indicated by a numeric number and type of adverse event

  21 months

• Assessment of Participants Perception

  Measured via Qualtrics survey asking participants "How satisfied were you in participating in this study" using an ordinal scale (0-4): (4)(strongly agree; (3)agree; (2)neutral; (1)disagree; (0)strongly disagree); with a higher score reflection increased satisfaction

  21 months

Secondary Outcomes (8)

• Balance

  21 months

• Gait

  21 months

• Physical Activity

  21 months

• Gait Speed

  21 months

• Functional Strength

  21 months

Study Arms (2)

Multimodal Exercise Program with Gamification

EXPERIMENTAL

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.

Other: Multimodal Exercise Program with Gamification

Wait List Control

NO 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.

Interventions

Multimodal Exercise Program with Gamification OTHER

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

Multimodal Exercise Program with Gamification

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ability to stand unassisted for 10 minutes
• stable on Parkinson's disease medications for 3 months as determined by physician
• medical clearance by their PCP, neurologist, or movement disorder specialist to participate in a moderate to vigorous exercise program.

You may not qualify if:

• 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.
• required

Sponsors & Collaborators

• California State University, Northridge: lead

Study Sites (1)

Equilibrium Physical Therapy

Ventura, California, 93003, United States

RECRUITING

Related Publications (7)

• Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.

  PMID: 29228079 BACKGROUND

• Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.

  PMID: 34812790 BACKGROUND

• El-Kotob R, Giangregorio LM. Pilot and feasibility studies in exercise, physical activity, or rehabilitation research. Pilot Feasibility Stud. 2018 Aug 14;4:137. doi: 10.1186/s40814-018-0326-0. eCollection 2018.

  PMID: 30123527 BACKGROUND

• Landers MR, Ellis TD. A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy. JMIR Mhealth Uhealth. 2020 Oct 5;8(10):e18985. doi: 10.2196/18985.

  PMID: 33016887 BACKGROUND

• Sangarapillai K, Norman BM, Almeida QJ. Boxing vs Sensory Exercise for Parkinson's Disease: A Double-Blinded Randomized Controlled Trial. Neurorehabil Neural Repair. 2021 Sep;35(9):769-777. doi: 10.1177/15459683211023197. Epub 2021 Jun 13.

  PMID: 34121511 BACKGROUND

• Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302.

  PMID: 34963139 BACKGROUND

• Langbroek-Amersfoort A, Schootemeijer S, Bouten L, Bloem BR, De Vries NM. Exercise Made Accessible: the Merits of Community-Based Programs for Persons with Parkinson's Disease. Curr Neurol Neurosci Rep. 2023 Nov;23(11):695-715. doi: 10.1007/s11910-023-01303-0. Epub 2023 Oct 4.

  PMID: 37792207 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Andrew S Bartlett, PhD

  California State University, Northridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew S Bartlett, PhD

CONTACT

5857646717; Andrew.Bartlett@csun.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Pilot Study

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: August 5, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): June 27, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately upon completion and until publication
• Access Criteria: Information will be shared upon request by the primary investigator.

Locations

US (1)