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

NCT03617991 | Completed

• 1 other identifier: IRB #43308
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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

Study Arms (2)

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.

Other: Exercise Group

Control Group

NO INTERVENTION

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

Interventions

Exercise Group 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.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johanna M. Hoch: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40539, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Johanna M Hoch, PhD, ATC

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 7, 2018
• Study Start: November 19, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)