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

Sponsor

New York Institute of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03389737

Collaborator

(none)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Body Weight Changes	Behavioral: Counseling Behavioral: Counseling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 7, 2017

Actual Primary Completion Date :

May 31, 2017

Actual Study Completion Date :

May 31, 2017

Arms and Interventions

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.
Active Comparator: Control Control group will not have monthly contact with the physicians.	Behavioral: Counseling Counseling on healthy behaviors with emails.

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.

Active Comparator: Control

Control group will not have monthly contact with the physicians.

Behavioral: Counseling

Counseling on healthy behaviors with emails.

Outcome Measures

Primary Outcome Measures

RAND-36 Survey [3 months]
Short form health survey

Secondary Outcome Measures

Patient Health Questionnaire 9 [3 months]
Depression scale. Indicates depression severity with higher scores meaning more severe depression.
Lean muscle mass [3 months]
Percent lean muscle mass
Adipose tissue [3 months]
Percent adipose tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 22 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYIT	Old Westbury	New York	United States	11568

Sponsors and Collaborators

New York Institute of Technology

Investigators

Principal Investigator: Hallie Zwibel, D.O., NYIT

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hallie Zwibel, Assistant Professor, New York Institute of Technology

ClinicalTrials.gov Identifier:

NCT03389737

Other Study ID Numbers:

BHS-1261

First Posted:

Jan 4, 2018

Last Update Posted:

May 7, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Body Weight

Body Weight Changes

Study Results

No Results Posted as of May 7, 2018