Recruiting
Early Phase 1

Exercise Program

Sponsor:

California State University, Northridge

Code:

NCT06538298

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Multimodal Exercise Program with Gamification

Study Details

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

Study ID

NCT06538298

Start date

Sep 15, 2024

Status verified date

Aug, 2024

Completion date

Jun 27, 2026

Anticipated

Primary completion date

May 26, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Multimodal Exercise Program with Gamification

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.

no intervention: Wait List Control

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

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

Primary outcome measure

  • Fidelity of intervention [ Time Frame: 21 months ]
  • Intervention Adherence [ Time Frame: 21 months ]
  • Feasibility of Outcomes [ Time Frame: 21 months ]
  • Assessment of Data Collection [ Time Frame: 21 months ]
  • Assessment of Safety [ Time Frame: 21 months ]
  • Assessment of Participants Perception [ Time Frame: 21 months ]

Central Contacts and Locations

Central contacts

Locations

Equilibrium Physical Therapy

Recruiting

Ventura, California, United States, 93003

Contacts

More Information

Sponsor

California State University, Northridge

Last update posted

Aug 7, 2024

Last verified

Aug, 2024

Keywords

  • Multimodal Exercise
  • Gamification
  • Parkinson's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by California State University, Northridge on 2024-08-07.