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

J

Johanna M. Hoch

Status

Completed

Conditions

Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture

Treatments

Other: Exercise Group

Study type

Interventional

Funder types

Other

Identifiers

NCT03617991
IRB #43308

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

27 participants in 2 patient groups

Exercise Group
Experimental group
Description:
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.
Treatment:
Other: Exercise Group
Control Group
No Intervention group
Description:
The control group will be contacted weekly to check on health status.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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