Mindful Miles Pilot Feasibility Study for Individuals With Patellofemoral Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of participants recruited to enroll in the study per week.
研究概览
简要总结
The goal of this single-arm pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a progressive outdoor mindful physical activity intervention delivered via the Headspace mobile application for individuals with patellofemoral pain.
AIM 1: Determine the feasibility and acceptability of the mindful activity intervention.
AIM 2: Determine the preliminary efficacy of the mindful running intervention to improve the primary outcome of (2a) anterior knee pain, and secondary outcomes of (2b) kinesiophobia and (2c) running cadence and vertical forces (gait kinematics) in individuals with PFP.
Our central hypothesis is that the intervention will be feasible and acceptable and will improve pain, kinesiophobia (injury-related fear), and running cadence (steps per minute) in individuals with patellofemoral pain.
Participants will complete a three-phase progressive mindful physical activity intervention that involves:
Phase 1: Introduction to mindfulness Phase 2: Guided mindful running Phase 3: Mindful running.
详细描述
One in four Americans suffer from chronic knee pain, leading to inactivity, poor health outcomes, and psychological distress. Patellofemoral pain (PFP) is the leading cause of knee pain in the United States and is not a self-limiting condition, meaning intervention is necessary to resolve or improve symptoms. Even with interventions to target biomechanics and strength, most young adults (40-90%) report unfavorable persistent symptoms 1-20 years after PFP diagnosis, significantly impacting long-term quality of life.
Psychological distress is a central feature of PFP that may impact physical activity engagement, symptoms, and long-term health outcomes. Injury-related fear (i.e., fear of pain, painful movement, reinjury) is a common form of psychological distress in individuals with PFP and is associated with pain and disability. Higher levels of fear are also associated with reduced step rate (i.e., cadence), a key biomechanical variable linked to increased load and injury risk. Walking and running are primary modes of physical activity in both the general population and high performing athletes, often the first step in return to activity plans, and key behaviors in a healthy lifestyle.
Despite the known negative consequences of kinesiophobia, few studies have examined psychologically focused interventions for individuals with PFP. Mindfulness, the ability to stay fully present without judgement, has been used to address chronic pain and kinesiophobia in this population. However, no studies have examined how integrating mindfulness during physical activity, when patients are most likely to experience pain and fear, can improve outcomes.
This study will investigate the 1) feasibility and acceptability and 2) preliminary efficacy of a progressive and technology based mindful physical activity intervention to reduce knee pain/disability, reduce pain-related fear, and increase running cadence in adults with patellofemoral pain.
Patients will complete a three phase progressive mindful physical activity using the Headspace mobile application including 1) Introduction to mindfulness: listening to the Headspace Pain Management Course at home (ten 10 minute sessions), 2) Guided mindful running: three runs on separate days (12, 15, and 20 minutes respectively) listening to guided running audio scripts from Headspace, and 3) Mindful running: three runs on separate days (12, 15, and 20 minutes respectively) with no audio input, integrating learned mindfulness and pain management skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Have access to an electronic mobile device that can be used to download the Headspace application
- •Meet the established diagnostic criteria for patellofemoral pain: pain in/around the anterior knee, and reproduction of this pain with movements that load the patellofemoral joint (i.e., squatting, stair climbing or descent, running, or jumping) based on self-report
排除标准
- •History of other musculoskeletal injuries in the past 6 months
- •Previous lower extremity musculoskeletal surgery in the past 12 months
- •Neuromuscular conditions that may affect movement,
- •Currently pregnant
- •Unable to attend in person study visits
- •Unable or unwilling to run for up to 20 minutes
研究组 & 干预措施
Progressive Mindful Physical Activity Intervention
干预措施: Progressive Mindful Physical Activity (Behavioral)
结局指标
主要结局
Number of participants recruited to enroll in the study per week.
时间窗: Through study completion, a total of approximately 6 months.
Feasibility of the progressive mindful physical activity intervention will be assessed through the recruitment rate of adults with patellofemoral pain. Recruitment rate is defined as the number of participants recruited to enrol in the study per week.
Percentage of interested and eligible participants who enrolled in the study
时间窗: Through study completion, a total of approximately 6 months
Feasibility of the progressive mindful physical activity intervention will be assessed through established recruitment of adults with patellofemoral pain. Recruitment is defined as the percentage of participants who expressed interest in the study, were eligible, and enrolled in the study.
Percentage of participants retained in the study
时间窗: Through study completion, a total of approximately 6 months
Feasibility of progressive mindful physical activity intervention will be assessed to determine participant retention. Retention is defined as the percentage of participants enrolled and who have completed all study measures through 5-weeks.
Mean Acceptability Score
时间窗: Collected post-intervention, approximately 5 weeks after the baseline visit
Acceptability of the progressive mindful physical activity intervention will be assessed via an acceptability survey, the Acceptability of the Intervention Measure (AIM) during the final assessment post-interventional week 5. Scores on the 4 item questionnaire range from 4 to 20. A mean score of 14 or greater will be interpreted as acceptable and a mean score of 16 or greater will be interpreted as high acceptability.
次要结局
- Change in pain-related fear as measured by the Tampa Scale of Kinesiophobia-11 Item (TSK-11)(Collected at baseline and at the post-intervention visit, approximately 5 weeks apart)
- Change in knee pain and disability as measured by the Anterior Knee Pain Scale (AKPS)(Collected at baseline and at the post-intervention visit, approximately 5 weeks apart)
- Change in running cadence (steps per minutes)(Collected at baseline and at the post-intervention visit, approximately 5 weeks apart)
