Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal Knee Injury

NCT ID: NCT03617991

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2020-04-30

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.

Conditions

Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise Group

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.

Group Type: EXPERIMENTAL

Exercise Group

Intervention Type: OTHER

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.

Control Group

The control group will be contacted weekly to check on health status.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise Group

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johanna M. Hoch

OTHER

Sponsor Role: lead

Responsible Party

Johanna M. Hoch

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johanna M Hoch, PhD, ATC

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

IRB #43308

Identifier Type: -

Identifier Source: org_study_id