Anterior Cruciate Ligament InjuryNCT03617991
Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal Knee Injury
A study testing Exercise Group in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Rupture, run by Johanna M. Hoch at 1 site in United States.
Trial summary
Negative outcomes impact individuals with a history of ACL reconstruction (ACLR) despite completion of formal rehabilitation and clearance to return to physical activity (PA). Focused exercises and targeted health education may improve these negative outcomes and increase quality of life. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
- What is being tested?
- Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 30 Apr 2020
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- History of unilateral ACL reconstruction,
- History of injuring their knee playing or training for sports (recreational or organized),
- Have been cleared to participate in activity, do not have radiographic evidence of post-traumatic osteoarthritis,
- Are free of neurological disorders, cardiopulmonary disease or any other condition that may impact their ability to participate
Who cannot join
- ACL reconstruction >10 years,
- Injury to either lower extremity within the last 6-weeks,
- Surgery to either limb within the last year,
- A BMI > 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal
Negative outcomes impact individuals with a history of ACL reconstruction (ACLR) despite completion of formal rehabilitation and clearance to return to physical activity (PA). Focused exercises and targeted health education may improve these negative outcomes and increase quality of life. The purpose of this study is determine the effects of an 8-week rehabilitation program on strength, sensorimotor function, functional performance and patient-reported outcomes in patients with a history of ACLR. A secondary aim will be to identify baseline PA levels and dietary intake patterns in these individuals. Participants will complete standard knee radiographs and all baseline measures, and resume normal activities of daily living for one-week while wearing an accelerometer to quantify PA levels and complete two, 24-hour dietary recalls to examine dietary patterns. After one-week, participants will come back to the laboratory and complete the pre-intervention assessments prior to randomization to the exercise or control group. After 8-weeks, participants will complete all outcome assessments 24-48 hours, 1-month and 3-months post exercise completion. The investigators hypothesize the intervention group will have significantly better outcomes post-intervention compared to the control group. In addition, the investigators hypothesize areas of educational and behavioral intervention related to PA engagement and dietary strategies to support weight management will be needed.
- Being tested
- Exercise Group
- Keywords
- rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise GroupOther
An 8-week home exercise program will be given to the participants. The program is designed to have four phases, progressed every two weeks. The participants will receive and email from study personnel every two weeks with new videos detailing the progression of exercises. The participants will be given all of the equipment to complete the exercises. The exercises will include balance and strength training exercises for the core and lower extremity.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants will be provided an 8-week home exercise program that they will complete. The participants will also be provided all of the equipment. An investigator will contact them weekly to ensure compliance and send You Tube videos with new Phases. Receives: Other: Exercise Group |
| Control Group | No intervention | The control group will be contacted weekly to check on health status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Joint Specific Self-Reported Function
Participants will complete the Knee Injury and Osteoarthritis Outcome (KOOS) survey to assess self-reported knee joint function across five domains (pain, symptoms, activities of daily living, sport and recreation, and quality of life). The questionnaire will include 42 questions across the domains, that are scored on a 5-point Likert scale. Each subscale is scored separately, and range from 0-100 (100=perfect self-reported knee function). The scores are transformed for each subscale as follows: 100-(actual raw score x 100)/ possible raw score. Participants will complete the survey at the time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the intervention, then at 1 and 3 month follow up visits. Data will be presented longitudinally as the change in self-reported function over the duration of the study, up to three months.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Secondary outcomes (9)
Change in Fear Avoidance Behaviors
Participants will complete the Fear Avoidance Belief Questionnaire (FABQ) to evaluate fear avoidance during activities of sport and physical activity. The FABQ is a 15-item survey, scored on a 6-point Likert scale where 6 is completely agree and 0 is completely disagree. There are 5 items in the FABQ-PA section and 10-items in the Sport section. Higher scores indicate elevate levels of fear avoidance beliefs. Participants will complete the survey at time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the intervention, then at 1 and 3 month follow up visits. Data will be presented longitudinally as the change of fear avoidance beliefs over the duration of the study and up to three months after the intervention.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in General Health-Related Quality of Life
Participants will complete the modified Disablement in the Physically Active Scale (mDPA) to evaluate general health related quality of life. This questionnaire will include 16 questions across two domains (physical and mental) and is scored on a 5-point Likert scale, where 0 indicates no problem and 4 indicates severe problem. The mDPA-physical component has 12-items, and scores can range from 0-48 while there are 4 items on the mDPA-mental and scores range from 0-16. Higher scores indicate decreased health-related quality of life. Scores are simply added for each component to get a final score. Participants will complete the survey at the time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the exercise regimen (intervention), then at 1 and 3 month follow up visits. Data will be presented longitudinally as the change in self-reported health related quality of life over the duration of the study, up to three months.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Knee related Self-Efficacy
Participants will complete the Knee Self-Efficacy Scale (KSES) to evaluate their knee-related self-efficacy. This questionnaire will include 22 questions, each scored on a 0-10 scale where 0-not at all certain and 10-very certain. There are four sections: Daily activities, sport and leisure activities, physical activities and knee function in the future. The sum of the items is calculated and then divided by the total number of items to get a total score. Higher scores indicate greater levels of knee self-efficacy. Participants will complete the survey at the time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the exercise regimen (intervention), then at 1 and 3 month follow up visits. Data will be presented longitudinally as the change in knee-related self-efficacy through the duration of the study, up to three months.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Fear of Movement
Participants will complete the Tampa Scale of Kinesiophobia-11(TSK-11) to evaluate their fear of movement/re-injury. This is an 11-item scale scored on a 4-point Likert scale where 1=strongly disagree and 4= strongly agree. The total score is a sum of all items, with scores ranging from 11-44. Participants will complete the survey at the time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the intervention, then at 1 and 3 month follow up visits. Data will be presented longitudinally as the change in fear of movement and re-injury over the duration of the study, up to three months.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-exercise completion, 1-month post, 3-months post
Change in Dynamic Balance
Participants will complete the Y-balance test as a measure of dynamic balance. This assessment will require the participant to stand on a plastic box, and push a plastic box as far as they can in three different directions. This will be done on both feet, and a measure of dynamic balance will be determined for all three directions. Participants will complete this measure at time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the intervention, then at 1 and 3 month follow up visits. Data will be presented longitudinally as the change in dynamic balance over the duration of the study, up to three months.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Static Balance
Participants will complete the Balance Error Scoring System to evaluate their static balance. This will include the participants standing barefoot, on one limb, with their eyes closed while an investigator counts their errors. The participants will complete this assessment at the time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the intervention, and then at 1 and 3 month follow-up visits. Data will be presented longitudinally as the change in static balance over the duration of the study, up to three months.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Functional Abilities
Participants will complete 4 functional hops (4 hop series) to evaluate their functional abilities. The functional hop series will include the: triple hop for distance where the patient will be asked to hop three times, on one leg, as far as they can; the single-leg hop for distance where the participant will be asked to hop as far as they can on one leg; the crossover hop for distance where the patient will be asked to hop back and forth for a certain distance and the six-meter timed hop where the patient will be asked to hop as fast as they can for six meters. Participants will complete these tests at the time of consent, one week later just prior to the intervention, up to 48 hours after completion of the intervention, then at 1 and 3 month follow-up visits. Data will be presented longitudinally as the change in function over the duration of the study, up to three months.
Measured: Baseline, pre-intervention )(one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Landing Errors
Participants will complete the Landing Error Scoring System to evaluate their landing errors. This will involve standing on a 30cm box, and jumping out and up four times. The investigator will assess the number of errors at each jump. Participants will complete this assessment at the time of consent, one week later just prior to initiation of the intervention, up to 48 hours after completion of the intervention, then at 1 and 3 month follow-up visits. Data will be presented longitudinally as the change in landing errors over the duration of the study and up to 3 months.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Strength
Participants will have their knee and hip muscle strength tested using a hand held device. The measurements of strength will include: knee extension, knee flexion, hip abduction, hip adduction, hip flexion and hip extension. Participants will complete these measurements at the time of consent, one week later just prior to the initiation of the intervention, 48-hours after completion of the intervention, then at 1 and 3 month follow-up visits. Data will be presented longitudinally as the change in strength measurements over the duration of the study, up to three months.
Measured: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start19 Nov 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johanna M. Hoch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johanna M. Hoch, University of Kentucky
- Investigators
- Johanna M Hoch, PhD, ATC, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617991
- Sponsor's protocol ID
- IRB #43308
- Status last verified
- Apr 2020
- First submitted
- 6 Jul 2018
- Last updated
- 4 May 2020
- 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 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal
- ClinicalTrials.gov ID
- NCT03617991
- Acronym / sponsor ID
- IRB #43308
- Keywords
- rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Johanna M. HochUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 7 Aug 2018 (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.
Negative outcomes impact individuals with a history of ACL reconstruction (ACLR) despite completion of formal rehabilitation and clearance to return to physical activity (PA). Focused exercises and targeted health education may improve these negative outcomes and increase quality of life. The purpose of this study is determine the effects of an 8-week rehabilitation program on strength, sensorimotor function, functional performance and patient-reported outcomes in patients with a history of ACLR. A secondary aim will be to identify baseline PA levels and dietary intake patterns in these individuals. Participants will complete standard knee radiographs and all baseline measures, and resume normal activities of daily living for one-week while wearing an accelerometer to quantify PA levels and complete two, 24-hour dietary recalls to examine dietary patterns. After one-week, participants will come back to the laboratory and complete the pre-intervention assessments prior to randomization to the exercise or control group. After 8-weeks, participants will complete all outcome assessments 24-48 hours, 1-month and 3-months post exercise completion. The investigators hypothesize the intervention group will have significantly better outcomes post-intervention compared to the control group. In addition, the investigators hypothesize areas of educational and behavioral intervention related to PA engagement and dietary strategies to support weight management will be needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise GroupParticipants will be provided an 8-week home exercise program that they will complete. The participants will also be provided all of the equipment. An investigator will contact them weekly to ensure compliance and send You Tube videos with new Phases. |
| Control Group | No intervention | –The control group will be contacted weekly to check on health status. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of unilateral ACL reconstruction,
- History of injuring their knee playing or training for sports (recreational or organized),
- Have been cleared to participate in activity, do not have radiographic evidence of post-traumatic osteoarthritis,
- Are free of neurological disorders, cardiopulmonary disease or any other condition that may impact their ability to participate
Key exclusion criteria (4 listed)
- ACL reconstruction >10 years,
- Injury to either lower extremity within the last 6-weeks,
- Surgery to either limb within the last year,
- A BMI > 30
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 |
|---|---|---|
| Exercise GroupAn 8-week home exercise program will be given to the participants. The program is designed to have four phases, progressed every two weeks. The participants will receive and email from study personnel every two weeks with new videos detailing the progression of exercises. The participants will be given all of the equipment to complete the exercises. The exercises will include balance and strength training exercises for the core and lower extremity. | Other | Exercise Group |
Primary outcome
Change in Joint Specific Self-Reported Function
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Participants will complete the Knee Injury and Osteoarthritis Outcome (KOOS) survey to assess self-reported knee joint function across five domains (pain, symptoms, activities of daily living, sport and recreation, and quality of life). The questionnaire will include 42 questions across the domains, that are scored on a 5-point Likert scale. Each subscale is scored separately, and range from 0-100 (100=perfect self-reported knee function). The scores are transformed for each subscale as follows: 100-(actual raw score x 100)/ possible raw score. Participants will complete the survey at the time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the intervention, then at 1 and 3 month follow up visits. Data will be presented longitudinally as the change in self-reported function over the duration of the study, up to three months.
9 secondary outcomes
Change in Fear Avoidance Behaviors
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in General Health-Related Quality of Life
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Knee related Self-Efficacy
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Fear of Movement
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-exercise completion, 1-month post, 3-months post
Change in Dynamic Balance
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Static Balance
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Functional Abilities
Time frame: Baseline, pre-intervention )(one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Landing Errors
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Change in Strength
Time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
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 4 May 2020.
- Individual participant dataSharing planned: No
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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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.
Johanna M Hoch, PhD, ATC principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Group in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Rupture, run by Johanna M. Hoch 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 4 inclusion and 4 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 4 May 2020. 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?
Change in Joint Specific Self-Reported Function (time frame: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post). 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 4 May 2020.