Clinical trial NCT05542563: Mindfulness and ACL Surgery
Official title: The Influence of Mindfulness on Patient-Reported Outcomes, Return to Sport and Re-Injury Following Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL
ACL Injury
Keywords: ACL Surgery
mindfulness
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following ACL reconstruction surgery
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament (ACL) surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting adverse effects such as muscle weakness, diminished joint function, hip pain, and fear. Many of these patients report more significant anxiety and depression following surgery, which can further compound these patients' adverse outcomes. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes (PROs) following ACL reconstruction surgery.

Detailed description: Rationale and Approach: ACL reconstruction surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential adverse long-lasting effects such as muscle weakness, arthritis, persistent knee pain, anxiety, depression, post-traumatic stress, and fear of re-injury. Many of these patients report sufficient psychological trauma that undermines a return to sport and potentially contributes to the risk of re-injury to the repaired knee. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following ACL reconstruction surgery.

* Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes and return to sport following ACL reconstruction surgery

  * Hypothesis 1: Mindfulness training will be associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery
* Specific Aim 2: To determine the influence of mindfulness training on re-injury risk following ACL reconstruction surgery

  * Hypothesis 2: Among those participants that return to sport, mindfulness training will be associated with a decreased risk of ipsilateral ACL rupture in the 24 months following ACL reconstruction surgery
* Specific Aim 3: To determine the factors that influence mindfulness efficacy in patient-reported outcomes and return to sport following ACL reconstruction surgery

  * Hypothesis 3: Among participants in the mindfulness group, total duration of mindfulness training and female gender will be independently associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery

Eligibility criteria: Inclusion Criteria:

* 16-40 years old at the time of the pre-operative visit
* Regular access to a mobile device compatible with the Healthy Minds Program (HMP) App (Android or iOS)
* Undergoing ACL surgery

Exclusion Criteria:

* Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc).
* Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year
* Knee injury requiring multi-ligament reconstruction
* Prior ipsilateral knee surgery
* Prior contralateral ACL reconstruction

Primary outcomes:
measure: Change in PROMIS Global Health Questionnaire (GHQ) Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in PROMIS Anxiety Questionnaire Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in PROMIS Depression Questionnaire Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Single Assessment Numeric Evaluation (SANE) Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Horowitz Impact of Events Scale Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Pain Catastrophizing Scale (PCS) Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Athletic Identity Measurement Scale (AIMS) Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary outcomes:
measure: Knee Range of Motion
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Peak Torque
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Peak Torque Relative to Body Weight
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Hamstring to Quadriceps Torque Ratio
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Jump Landing Assessment: Force Measures
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Jump Height
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Vertical Hop Testing: Force Measures
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Change in Hop Height
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
measure: Total Duration of Mindfulness Intervention in the Mindfulness Group
timeFrame: up to 24 months
measure: Number of Participants Who Return to Sport
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Andrew Watson, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: