Clinical trial NCT03617991: Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal Knee Injury
Official title: Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture
Keywords: rehabilitation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Joint Specific Self-Reported Function
timeFrame: 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:
measure: Change in Fear Avoidance Behaviors
timeFrame: 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
measure: Change in General Health-Related Quality of Life
timeFrame: 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
measure: Change in Knee related Self-Efficacy
timeFrame: 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
measure: Change in Fear of Movement
timeFrame: 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
measure: Change in Dynamic Balance
timeFrame: 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
measure: Change in Static Balance
timeFrame: 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
measure: Change in Functional Abilities
timeFrame: 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
measure: Change in Landing Errors
timeFrame: 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
measure: Change in Strength
timeFrame: 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
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Johanna M Hoch, PhD, ATC
role: PRINCIPAL_INVESTIGATOR
References: