Evaluating the Impact of Focused Muscle Contraction Therapy in Retire APF Players (GH-APF)

Evaluating the Impact of Focused Muscle Contraction Therapy in Retired American Professional Football Players

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.

Study Overview

• Status: Completed
• Conditions: Depression; Brain Injuries; Acute Pain; Chronic Pain Due to Injury
• Intervention / Treatment: Behavioral: Experimental: Investigate the effects of an exercise intervention on retired APF players

Detailed Description

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:

• participants will be asked to confirm their employment status each visit.
• participants height and weight will be measured and their body mass index (BMI) will be calculated. Additionally, we will measure body fat composition and lean body mass using a DEXA scan.
• We will ask about age, race, years in the APF league, number of concussions, number of fractures, surgical history, and list of pain medications.
• Waist circumference as well as blood pressure will be measured for general health markers.
• Participants exercise limit will be measured with a 1 Repetition Max test (1RM), a timed 8 foot walk down the hallway (if applicable), a timed sit to stand test (sitting and standing 5 times in a row-if applicable), maximum sit to stands, and a balance test (standing in 3 different positions for 10 seconds each). These three tests combine to form a score called a short performance battery score.
• Their strength and frailty will be measured using a grip dynamometer (squeezing a hand held device as hard as possible in their dominant hand three times.
• To evaluate general health, the PROMIS v.1.1 - Global Health questionnaire will be administered.
• To evaluate mental health and pain intensity, the PROMIS 29 Profile v2.0 will be administered.
• To evaluate quality of life, the SF-36 will be administered.
• To evaluate mental health, specifically depression, the Beck Depression Inventory will be administered.
• To evaluate brain anatomy and function, we will be using a quantitative EEG (QEEG), and a computer program called the Integrated Visual and Auditory Scale (IVA-2). For the QEEG, a technician will attach discs (electrodes) to the scalp of the participant using a special adhesive. Sometimes, an elastic cap fitted with electrodes is used instead. The electrodes are connected with wires to an instrument that amplifies the brain waves and records them on computer equipment. The electrodes don't transmit any sensations. They just record brain waves. For the IVA-2, you will perform tasks on a computer that will test sustained attention.
• To evaluate the measure of pain and disability, the Numeric Rating Scale and Pain Catastrophizing Scale will be administered.
• To evaluate fatigue, the Fatigue Severity Index will be administered.
• They will be asked to disclose the number of hospital visits they have had in the last 18 months.
• Their total weight lifted during their training session will also be recorded.

Exercise Training Visits

After the initial baseline visit, participants will begin their exercise training intervention which involves:

• Two days a week of exercise trainings for the first 6 months, and one day a week from 6-12 months. From 12-18 months, participants will then complete two days a month of exercise training. Each visit will last roughly one hour and will incorporate approximately 5-10 minute light warm-up plus stretching and then the exercises.
• At least twice weekly, GH Fitness staff will follow-up with participants via text message, email or a phone call to evaluate their physical progress and overall health and energy.
• On Weeks 6, 13, 18, 25, 41 and 52 participants will focus on cardio and endurance exercises. These exercises may include running in place, or using a recumbent (stationary) bike. All other weeks consist of basic strength training/resistance workouts.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Investigate the effects of an exercise intervention on retired APF players; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Enrico Benedetti, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Actual): April 18, 2021
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Chronic Pain; Brain Injuries; Wounds and Injuries; Acute Pain
• Other Study ID Numbers: 2019-0905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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