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临床试验/NCT04775589
NCT04775589进行中(未招募)不适用

Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

Durham VA Medical Center2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
19
试验地点
2
主要终点
Western Ontario and McMaster Universities Osteoarthritis Index

研究概览

简要总结

The goal of this study is to evaluate a telehealth Stepped Exercise Program for Knee OsteoArthritis (STEP-KOA) among rural veterans. Methods: This is a single arm, pre-post pilot trial of the 6-month STEP-KOA program among rural Veterans with a physician diagnosis of knee OA who self-report knee pain ≥3 on a 0-10 scale and self-reported difficulty with either walking or stair climbing. We aim to enroll 20 Veterans in this project but may enroll up to 30 in order to obtain sufficient information to evaluate the program, particularly among Veterans who live in very rural areas. Assessments will be conducted via a combination of telephone and video at baseline and 2-, 4-, and 6-month follow-up. Assessments will include questionnaires related to pain, function and physical activity, as well as several physical performance tests. STEP-KOA begins with a low cost, primarily self-directed exercise program (supported by an internet-based tool; Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps. For this project, patients will be assessed approximately every 2 months to determine step progression. Participants will advance to the next step if they do not meet response criteria for pain and function established by the Outcome Measures in Rheumatology group and the Osteoarthritis Research Society International (OMERACT-OARSI). The Step 2 intervention involves bi-weekly telephone or video calls. Step 3 involves 3 telehealth PT visits, based on standard care for knee OA.

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

入选标准

  • Rural dwelling Veterans (VA healthcare users)
  • Clinician diagnosis of knee osteoarthritis
  • Self-reported knee pain =>3 on a scale of 0-10 and self-reported difficulty either walking or stair climbing.

排除标准

  • Advanced Dementia
  • Psychosis
  • Active substance abuse disorder
  • Meniscus or ACL tear in the past 6 months
  • Total joint replacement or other major lower extremity surgery in the past 6 months
  • Severe hearing or visual impairment (e.g. unable to participate in STEP-KOA intervention components)
  • Serious / terminal illness
  • Unstable angina
  • History of ventricular tachycardia
  • Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)
  • Uncontrolled hypertension (diastolic blood pressure >110 mm/Hg or systolic > 200mm/Hg)
  • Stroke with moderate to severe aphasia
  • Recent history of falls
  • Resident of a long-term care facility
  • Hospitalization for a cardiovascular condition in the past 3 months
  • Other health conditions that would make home exercise unsafe or participation in the program not feasible

结局指标

主要结局

Western Ontario and McMaster Universities Osteoarthritis Index

时间窗: Baseline to 6 months

24-item measure assessing lower extremity pain, stiffness and function. All items are measured on a 5-point Likert scale (0-4; total score 0-96), with higher scores indicating worse symptoms.

次要结局

  • 2 minute march test(Baseline to 6 months)
  • 30-second chair stand test(Baseline to 6 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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