NCT04822311

Brief Summary

This study will investigate the effects of an exercise intervention on retired American professional football (APF) players. A total of 20 retired APF players (≥ 18 years of age), who suffer from chronic pain, will be enrolled. The study duration for each participants will be 18 months. Enrolled participants will perform a 18 months exercise intervention which involves 90 exercise rehabilitation training visits. In addition, participants will also be tested on various measures of health and function both at baseline (prior to intervention), at 6 months, 12 months, and 18 months (post intervention). All testing and result interpretation will be performed by trained research personnel. Participants are not University of Illinois at Chicago (UIC) participants; however, study testing visits will occur at UIC. All exercise intervention training visits will occur at Gh Fitlab.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

March 25, 2021

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate at which exercise will positively affect body composition

    1\. Exercise will positively affect body composition. With this hypothesis we will test whether muscle strength (dynamometer) and muscle mass (DEXA scan) changes after 6 months, 12 months, 18 months of an exercise intervention. Baseline measurement will be performed before the intervention, at 6 months, 12 months, and at the end of the study (18 months) with muscle mass measured by DEXA and strength measured again by dynamometer.

    18 months

Secondary Outcomes (3)

  • Rate at which participants will see improvements in their physical abilities

    18 months

  • Rate at which participants will have overall improved sense of well-being, increased independence, quality of life, and decreased depression

    18 months

  • Rate at which participants will display alterations in brain wave function

    18 Months

Study Arms (1)

Investigate the effects of an exercise intervention on retired APF players

EXPERIMENTAL

20 retired APF players (≥ 18 years of age), who suffer from chronic pain, will be enrolled.

Behavioral: Experimental: Investigate the effects of an exercise intervention on retired APF players

Interventions

Enrolled participants will perform a 18 months exercise intervention which involves 90 exercise rehabilitation training visits. In addition, participants will also be tested on various measures of health and function both at baseline (prior to intervention), at 6 months, 12 months, and 18 months (post intervention).

Investigate the effects of an exercise intervention on retired APF players

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Retired APF player (there is no minimum duration or career length required no minimum duration or career length required)
  • years of age and older

You may not qualify if:

  • This study will exclude non-English speaking participants as they would not be able to complete intensive survey requirement of the study as all surveys will be administered in the English language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Acute PainDepressionBrain Injuries

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Enrico Benedetti, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Warren H. Cole Chair in Surgery, Professor and Head of Surgery, Medical Director, Abdominal Organ Transplant Program

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

October 24, 2019

Primary Completion

April 18, 2021

Study Completion

May 15, 2023

Last Updated

June 9, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations