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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.
Methods:
Eligible participants will give voluntary informed consent to participate in the study. The study will include 20 retired APF players participating in a 18 month exercise rehabilitation. The study will consist of 94 visits (4 study testing visits and 90 exercise visits). Participants will come in for study testing visits at baseline (prior to starting the exercise program), at 6 months, at 12 months, and at 18 months(after ending the exercise program). Each of those visits will take about 2-3 hours. All testing done in the 4 test visits will help assess the participant's cardiovascular and functional responses and/or changes to the exercise intervention as indicated in the Objectives/Aims Section. The next section contains a list of the tests that will be performed at each visit. After the initial baseline visit, participants will come twice weekly, for roughly 1 hour each session, for 6 months (52 visits). From 6-12 months, participants will come once a week, for roughly 1 hour each session (26 additional visits). From 12-18 months, participants will come twice a month, for roughly 1 hour sessions (12 visits). All study testing visits will occur at the UIC. All exercise intervention training visits will occur at Gh Fitlab.
Study Testing Visits
If participants agree to be in the study, they will be asked to do the following procedures at baseline, 6 months, 12 months, and 18 months:
Exercise Training Visits
After the initial baseline visit, participants will begin their exercise training intervention which involves:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Investigate the effects of an exercise intervention on retired APF players | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate at which participants will see improvements in their physical abilities | 2. We expect participants will see improvements in their physical abilities after 18 months in the exercise training sessions. This will be assessed by comparing baseline, 6 months, 12 months, and 18 months, 8 foot walk, timed sit to stand, and balance testing scores. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
•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.
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| Name | Affiliation | Role |
|---|---|---|
| Enrico Benedetti, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2021 | Jun 7, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D003863 | Depression |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Rate at which participants will have overall improved sense of well-being, increased independence, quality of life, and decreased depression | 3. Participants enrolled in the exercise intervention will have an overall improved sense of well-being, increased independence, quality of life, and decreased depression. Participants will be asked about their overall general health, mental health and pain intensity using the PROMIS, SF 36, BDI, Fatigue Severity Index, and pain assessments. | 18 months |
| Rate at which participants will display alterations in brain wave function | 4. APF players with chronic pain described as greater than 5 out of a 10 point scale and lasting greater than 12 months, will display alterations in brain wave function consistent with abnormal function of the bilateral dorsolateral prefrontal cortex (DLPFC) , thalamus (relays motor and sensory signals to the cortex) , brainstem, primary somatosensory cortex (S1, postcentral gyrus of the anterior parietal lobe) and posterior parietal cortex (posterior to the primary somatosensory cortex) | 18 Months |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |