The Effects of the Novel "Step Up Your Game" Program on Men's Lacrosse

The Effects of the Novel "Step Up Your Game" Program on Men's Collegiate Lacrosse Players: A Comparative Study of a Comprehensive Osteopathic Approach on Performance

For the purpose of this pilot study, the investigators hypothesize that the use of the Step Up Your Game protocol will result in statistically significant improvements in health and athletic performance. The key to this is the coordination of resources from a supervising physician, physical therapist, trainer, dietitian, coach, competitor, role model, psychologist, and spiritual leader. Notably, Step Up Your Game provides resources which would allow patients to find or be their own physical therapist, trainer, dietitian, coach, competitor, role model, psychologist, and spiritual leader. The role of the supervising physician, however, is meant for a qualified professional, who follows the osteopathic approach to medicine, in which the body is treated as an integrated whole, while also working to prevent and treat injuries. Though not limited solely to osteopathic physicians, it is critical to take into account every health aim and injury in the context of the athlete and how these affect all aspects of participants lives.

Study Overview

• Status: Completed
• Conditions: Body Weight Changes
• Intervention / Treatment: Behavioral: Counseling; Behavioral: Counseling

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • NYIT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Individuals capable of giving consent between ages of 18 and 22.
• Must be members of the NYIT lacrosse team.

Exclusion Criteria:

• Individuals who are not able to participate throughout the season whether it's due to a medical problem or academic probation.
• Individuals who are receiving sports related medical care other than that from the physician in study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Experimental group will have monthly contact with the physicians, during which the athletes will receive individualized care and guidance in support of their performance goals.	Behavioral: Counseling; Counseling on healthy behaviors with in person meetings.; Behavioral: Counseling; Counseling on healthy behaviors with emails.
ACTIVE_COMPARATOR: Control; Control group will not have monthly contact with the physicians.	Behavioral: Counseling; Counseling on healthy behaviors with in person meetings.; Behavioral: Counseling; Counseling on healthy behaviors with emails.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RAND-36 Survey	Short form health survey	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire 9	Depression scale. Indicates depression severity with higher scores meaning more severe depression.	3 months
Lean muscle mass	Percent lean muscle mass	3 months
Adipose tissue	Percent adipose tissue	3 months

Collaborators and Investigators

• Sponsor: New York Institute of Technology
• Investigators: Principal Investigator: Hallie Zwibel, D.O., NYIT

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2017
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): May 31, 2017

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: BHS-1261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers may contact PI for details.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No