Chronic Pain Due to InjuryGH-APFNCT04822311
Evaluating the Impact of Focused Muscle Contraction Therapy in Retire APF Players
A study testing Experimental: Investigate the effects of an exercise intervention on retired APF players in people with Chronic Pain Due to Injury and Acute Pain, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Pain Due to Injury, Acute Pain, Depression
- What is being tested?
- Experimental: Investigate the effects of an exercise intervention on retired APF players
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- •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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain Due to Injury, Acute Pain, Depression, Brain Injuries
- Being tested
- Experimental: Investigate the effects of an exercise intervention on retired APF players
- Medical subject headings
- Acute Pain, Depression, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Investigate the effects of an exercise intervention on retired APF playersBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Experimental: Investigate the effects of an exercise intervention on retired APF players |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate at which exercise will positively affect body composition
- 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.
Measured: 18 months
Secondary outcomes (3)
Rate at which participants will see improvements in their physical abilities
- 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.
Measured: 18 months
Rate at which participants will have overall improved sense of well-being, increased independence, quality of life, and decreased depression
- 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.
Measured: 18 months
Rate at which participants will display alterations in brain wave function
- 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)
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start24 Oct 2019
- Primary completion18 Apr 2021
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain Due to InjuryStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Benedetti, University of Illinois Chicago
- Investigators
- Enrico Benedetti, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822311
- Sponsor's protocol ID
- 2019-0905
- Acronym
- GH-APF
- Status last verified
- Jun 2023
- First submitted
- 25 Mar 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Focused Muscle Contraction Therapy in Retired American Professional Football Players
- ClinicalTrials.gov ID
- NCT04822311
- Acronym / sponsor ID
- GH-APF / 2019-0905
- Conditions
- Chronic Pain Due to Injury, Acute Pain, Depression, Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigate the effects of an exercise intervention on retired APF players | Experimental | Behavioral: Experimental: Investigate the effects of an exercise intervention on retired APF players20 retired APF players (≥ 18 years of age), who suffer from chronic pain, will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- •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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Investigate the effects of an exercise intervention on retired APF playersEnrolled 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). | Behavioural | Investigate the effects of an exercise intervention on retired APF players |
Primary outcome
Rate at which exercise will positively affect body composition
Time frame: 18 months
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.
3 secondary outcomes
Rate at which participants will see improvements in their physical abilities
Time frame: 18 months
Rate at which participants will have overall improved sense of well-being, increased independence, quality of life, and decreased depression
Time frame: 18 months
Rate at which participants will display alterations in brain wave function
Time frame: 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico Benedetti, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Investigate the effects of an exercise intervention on retired APF players in people with Chronic Pain Due to Injury and Acute Pain, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate at which exercise will positively affect body composition (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.