Multidimensional Assessment of the Activities of the "Camina 60+" Program for the Promotion of Healthy Aging - Adding Group-Based Pain Neuroscience Education to a Community Exercise Program for Older Women With Knee Osteoarthritis: A Pilot Randomized Trial of Feasibility and Preliminary Effects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- KOOS - Activities of Daily Living (KOOS-ADL)
研究概览
简要总结
This pilot trial aimed to estimate preliminary clinical effects and to assess the feasibility of adding group-based pain neuroscience education (PNE) to exercise in women aged ≥60 years with medically diagnosed knee osteoarthritis and current knee pain. Participants were randomized to either 10 weeks of community-based exercise plus PNE or exercise alone. All participants attended weekly group exercise sessions, and those in the intervention group also participated in five in-person group-based PNE sessions lasting 30 minutes each. Physical fitness tests were administered, and participants completed questionnaires assessing disability, pain intensity, and pain neurophysiology knowledge.
详细描述
Knee osteoarthritis (OA) is a highly prevalent and disabling condition in older adults, with the knee being the most commonly affected joint. In Chile, OA represents a substantial clinical and public health burden, particularly among women aged 60 years and older, who experience high rates of pain, disability, and loss of functional independence. Disability and pain are hallmark symptoms of knee OA and are strongly associated with reduced physical function and poorer quality of life in older women. Current clinical guidelines recommend education, self-management, and exercise as first-line treatments. Exercise therapy can improve pain and physical function in people with knee OA, but average effects are modest and individual responses vary. Pain in knee OA is increasingly understood within a biopsychosocial framework, suggesting that maladaptive pain beliefs contribute to persistent symptoms. Pain Neuroscience Education (PNE) may complement exercise by improving pain-related knowledge and psychological outcomes, although evidence-particularly for group-based delivery and disability outcomes in older women-remains limited. This study was implemented in the context of a training program called "Camina 60+KineUC", a community-based program jointly delivered by the UC Older Adults Program and the Department of Physical Therapy from Pontificia Universidad Católica de Chile. The program provides weekly group sessions focused on strength, aerobic, balance, and flexibility exercises for adults aged 60 years and older and is designed to promote healthy aging. The study was designed to assess feasibility and estimate preliminary between-group effect sizes rather than to make definitive efficacy conclusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Medical diagnosis of knee osteoarthritis with current knee pain.
排除标准
- •Inability to understand study procedures during baseline assessment. Mini-Mental State Examination (MMSE) cutoff used to define adequate comprehension for study participation was ≥24/30).
- •Severe neurological disease.
- •Anticipated inability to attend all educational sessions or attendance less than 80% at the end of the program.
研究组 & 干预措施
Exercise plus Pain Neuroscience Education
In addition to the 10-week Camina 60+KineUC exercise program, this group received five in-person group-based Pain Neuroscience Education (PNE) sessions lasting 30 minutes each. Sessions were delivered across the intervention period using standardized digital presentations, for a total dose aligned with evidence suggesting psychosocial benefits when PNE is combined with exercise. The intervention was delivered by four fourth-year physical therapy students trained in PNE, based on recognized educational resources. Intervention fidelity was ensured through prior training, use of standardized materials, and adherence to a prespecified session checklist.
干预措施: Pain neuroscience education (PNE) (Other)
Exercise plus Pain Neuroscience Education
In addition to the 10-week Camina 60+KineUC exercise program, this group received five in-person group-based Pain Neuroscience Education (PNE) sessions lasting 30 minutes each. Sessions were delivered across the intervention period using standardized digital presentations, for a total dose aligned with evidence suggesting psychosocial benefits when PNE is combined with exercise. The intervention was delivered by four fourth-year physical therapy students trained in PNE, based on recognized educational resources. Intervention fidelity was ensured through prior training, use of standardized materials, and adherence to a prespecified session checklist.
干预措施: Exercise program (Other)
Exercise-only group
Camina 60+KineUC exercise program for 10 weeks, which consists of group exercise sessions delivered weekly, in person, and includes strength, aerobic, balance, and flexibility exercises. Each exercise session lasted 60min and was delivered by the monitors of Camina60+. Sessions included warm-up, strengthening, aerobic training, balance, and flexibility. Progression across the 10-week intervention period was standardized by movement complexity, or balance challenge according to tolerance. After study completion, they were offered the same group-based PNE program provided to the intervention group.
干预措施: Exercise program (Other)
结局指标
主要结局
KOOS - Activities of Daily Living (KOOS-ADL)
时间窗: Baseline and immediately after the 10-week intervention period.
Self-reported disability during activities of daily living, measured using the Activities of Daily Living subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a knee-specific, self-administered questionnaire. The ADL subscale is scored from 0 to 100, with higher scores indicating better knee-related function.
次要结局
- KOOS - Pain Subscale(Baseline and immediately after the 10-week intervention period.)
- KOOS - Symptoms Subscale(Baseline and immediately after the 10-week intervention period.)
- KOOS - Sport and Recreation Function Subscale(Baseline and immediately after the 10-week intervention period.)
- KOOS - Knee-related Quality of Life Subscale(Baseline and immediately after the 10-week intervention period.)
- Pain intensity(Baseline and immediately after the 10-week intervention period.)
- Lower-body functional performance(Baseline and immediately after the 10-week intervention period.)
- Pain neurophysiology knowledge(Baseline and immediately after the 10-week intervention period.)