Mindfulness and ACL Surgery
Primary Purpose
ACL, ACL Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Minds Program (HMP) App
Sponsored by
About this trial
This is an interventional treatment trial for ACL focused on measuring ACL Surgery, mindfulness
Eligibility Criteria
Inclusion Criteria:
- 18-30 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
Sites / Locations
- University of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness Intervention plus Standard of Care
Standard of Care
Arm Description
The Foundations and Awareness modules of the HMP app require a minimum of 133 and 253 minutes, equating to less than 5 and less than 10 minutes per day on average, respectively. Date, duration, and content of usage will be recorded for each participant through the app. Participants will have access to the entire contents of the app for the full duration of the study.
Control group receives standard of care only
Outcomes
Primary Outcome Measures
Change in PROMIS Global Health Questionnaire (GHQ) Score
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
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
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
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
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
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
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
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
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
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
Higher score indicates higher physical activity.
Secondary Outcome Measures
Knee Range of Motion
Peak Torque
Participants will undergo testing of resisted flexion and extension to determine peak torque
Peak Torque Relative to Body Weight
Participants will undergo testing of resisted flexion and extension to determine peak torque relative to body weight
Hamstring to Quadriceps Torque Ratio
Participants will undergo testing of resisted flexion and extension to determine hamstring to quadriceps torque ratio.
Change in Jump Landing Assessment: Force Measures
loading force, acceleration force, landing force, peak landing force on both legs together
Change in Jump Height
Change in Vertical Hop Testing: Force Measures
down force, up force, landing force, peak landing force on a single leg
Change in Hop Height
Total Duration of Mindfulness Intervention in the Mindfulness Group
Number of Participants Who Return to Sport
Full Information
NCT ID
NCT05542563
First Posted
September 12, 2022
Last Updated
January 23, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT05542563
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL, ACL Injury
Keywords
ACL Surgery, mindfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Care Provider
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.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Intervention plus Standard of Care
Arm Type
Experimental
Arm Description
The Foundations and Awareness modules of the HMP app require a minimum of 133 and 253 minutes, equating to less than 5 and less than 10 minutes per day on average, respectively. Date, duration, and content of usage will be recorded for each participant through the app. Participants will have access to the entire contents of the app for the full duration of the study.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Control group receives standard of care only
Intervention Type
Behavioral
Intervention Name(s)
Healthy Minds Program (HMP) App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PROMIS Global Health Questionnaire (GHQ) Score
Description
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.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in PROMIS Anxiety Questionnaire Score
Description
Anxiety will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in PROMIS Depression Questionnaire Score
Description
Depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater depression.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Single Assessment Numeric Evaluation (SANE) Score
Description
Pain severity is assessed via a single item survey scored from 0-100 where a higher score indicates greater pain.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Horowitz Impact of Events Scale Score
Description
Post-traumatic stress is assessed via a 15-item survey scored from 0-3 where higher scores indicate greater level of post-traumatic stress.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score
Description
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.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Pain Catastrophizing Scale (PCS) Score
Description
Pain catastrophizing is assessed via a 13-item survey scored from 0-4 where higher scores indicate a higher level of pain catastrophizing.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score
Description
Psychological readiness is assessed via a 12-item survey scored on an 11-point scale where higher scores indicate a higher level of readiness.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Athletic Identity Measurement Scale (AIMS) Score
Description
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.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
Description
Knee function is assessed via a 10-item survey scored from 0-10 where higher scores means less limitation with activities and less symptoms.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day
Description
Higher score indicates higher physical activity.
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary Outcome Measure Information:
Title
Knee Range of Motion
Time Frame
6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Peak Torque
Description
Participants will undergo testing of resisted flexion and extension to determine peak torque
Time Frame
6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Peak Torque Relative to Body Weight
Description
Participants will undergo testing of resisted flexion and extension to determine peak torque relative to body weight
Time Frame
6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Hamstring to Quadriceps Torque Ratio
Description
Participants will undergo testing of resisted flexion and extension to determine hamstring to quadriceps torque ratio.
Time Frame
6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Jump Landing Assessment: Force Measures
Description
loading force, acceleration force, landing force, peak landing force on both legs together
Time Frame
6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Jump Height
Time Frame
6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Vertical Hop Testing: Force Measures
Description
down force, up force, landing force, peak landing force on a single leg
Time Frame
6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Change in Hop Height
Time Frame
6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Title
Total Duration of Mindfulness Intervention in the Mindfulness Group
Time Frame
up to 24 months
Title
Number of Participants Who Return to Sport
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-40 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Haraldsdottir
Phone
608-263-6647
Email
ACLMindfulnessResearch@ortho.wisc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Watson, MD, MS
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness and ACL Surgery
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