Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04822311 |
| Other study ID # |
2019-0905 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 24, 2019 |
| Est. completion date |
May 15, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
University of Illinois at Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
