ACL, ACL Injury
Conditions
Keywords
ACL Surgery, mindfulness
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
Interventions
BEHAVIORALHealthy Minds Program (HMP) App
The full HMP app includes 5 modules with practices designed to cultivate categories of mental and emotional skills linked to both hedonic and eudaimonic well-being. These include the cultivation of mindful attention (Awareness), positive relationships with self and others (Connection), insight into the nature of self and internal experience (Insight), and purpose, values, and meaning in life (Purpose), as well as an initial module which includes abbreviated introductions to the topics and lessons in all four areas (Foundations). For this study, the active intervention will include 4 weeks of training using the Foundations module followed by 4 weeks of training using the Awareness module.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
All healthcare providers involved in the care of the participant following surgery (surgeon, physician's assistants, nurses, medical assistants, etc.) will be blinded to the group assignment of each participant.
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
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS Global Health Questionnaire (GHQ) Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Global quality of life (QoL) will be assessed via a 9-item questionnaire scored on a 0-100 scale where higher scores indicate better QoL, pain interference, and fatigue. |
| Change in PROMIS Anxiety Questionnaire Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Anxiety will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety. |
| Change in PROMIS Depression Questionnaire Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater depression. |
| Change in Single Assessment Numeric Evaluation (SANE) Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Pain severity is assessed via a single item survey scored from 0-100 where a higher score indicates greater pain. |
| Change in Horowitz Impact of Events Scale Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Post-traumatic stress is assessed via a 15-item survey scored from 0-3 where higher scores indicate greater level of post-traumatic stress. |
| Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Fear of re-injury is assessed via an 11-item survey scored from 1-4 where higher scores indicate a greater fear of re-injury. |
| Change in Pain Catastrophizing Scale (PCS) Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Pain catastrophizing is assessed via a 13-item survey scored from 0-4 where higher scores indicate a higher level of pain catastrophizing. |
| Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Psychological readiness is assessed via a 12-item survey scored on an 11-point scale where higher scores indicate a higher level of readiness. |
| Change in Athletic Identity Measurement Scale (AIMS) Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Athletic identity is assessed via a 10-item survey with a total range of scores from 10-70 where higher scores indicate a higher level of athletic identity. |
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Knee function is assessed via a 10-item survey scored from 0-10 where higher scores means less limitation with activities and less symptoms. |
| Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Higher score indicates higher physical activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Range of Motion | 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | — |
| Peak Torque | 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Participants will undergo testing of resisted flexion and extension to determine peak torque |
| Peak Torque Relative to Body Weight | 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Participants will undergo testing of resisted flexion and extension to determine peak torque relative to body weight |
| Hamstring to Quadriceps Torque Ratio | 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | Participants will undergo testing of resisted flexion and extension to determine hamstring to quadriceps torque ratio. |
| Change in Jump Landing Assessment: Force Measures | 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | loading force, acceleration force, landing force, peak landing force on both legs together |
| Change in Jump Height | 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | — |
| Change in Vertical Hop Testing: Force Measures | 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | down force, up force, landing force, peak landing force on a single leg |
| Change in Hop Height | 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery | — |
| Total Duration of Mindfulness Intervention in the Mindfulness Group | up to 24 months | — |
| Number of Participants Who Return to Sport | up to 24 months | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew Watson, MD, MS
University of Wisconsin, Madison
Outcome results
None listed