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临床试验/NCT04219423
NCT04219423已完成不适用

Feasibility and Preliminary Efficacy of Multi-modal Physical Therapy on Physical Performance and Health -Related Quality of Life in Hispanic Older Adults With Moderate Knee Osteoarthritis: a Pilot Study

Kaiser Permanente0 个研究点目标入组 20 人开始时间: 2016年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
Number of participants enrolled in the study

研究概览

简要总结

This is a small, pilot, pre/post evaluation study enrolling older Hispanic American adults with moderate knee arthritis to evaluate the feasibility of recruitment, retention and adherence after a multimodal 12-week, physical therapy intervention. The secondary aim is to evaluate preliminary estimates of change on physical performance and health related quality of life after the intervention.

详细描述

Background: Hispanic Americans (HAs) experience more pain and mobility deficits associated with knee osteoarthritis (OA) compared to non-Hispanic whites (NHWs) and seek total knee arthroplasties at a reduced rate, thus conservative treatments are needed. Prevalence of knee OA among the older HA population is rising dramatically. There is moderate evidence that lower extremity strengthening, manual therapy and self-management training improve pain and physical performance in people with knee OA and little evidence in the HA population. We conducted a pilot prospective trial implementing a multimodal high intensity targeted strength training, manual therapy and self-management education intervention to evaluate feasibility of recruitment, retention and adherence and preliminary estimates of change on physical performance and health related quality of life (HrQOL) in HAs with moderate knee OA. If this trial is feasible and shows promise for efficacy, it may warrant further testing as a primary treatment for knee OA.

Methods: Spanish speaking older adults will be recruited from Kaiser Permanente San Francisco through a medical record search. Participants will attended 10 physical thearpy clinic visits over 8 weeks, followed by 4 weekly phone calls to assess adherence to exercise via 1-week verbal recall. Participants will be instructed to exercise 3 days per week for the study duration combining both clinic and home exercise participation. The intervention is led in Spanish and will include progressive open and closed-chain quadriceps and gluteal strengthening, progressive cycling training with short power intervals, manual therapy and self-management training.

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

盲法说明

Small study staff precludes blinding of assessors and instructors.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate knee osteoarthritis Defined as Kellgren-Lawrence radiographic level 2 or 3
  • People who speak Spanish as a primary language
  • Age 50 or greater
  • pass a Phone screening: Reports problems with physical performance due to knee: Answers yes to 'Are you now limited in any way in any of your usual activities because of arthritis or joint?' Reports pain in their knee: Answers 'yes' to have you had pain in your knee in last 30 days? Be able to walk inside home without a cane, be able to walk ¼ of a block without a cane and be able to go up a flight of stairs without assistance from another

排除标准

  • Psychiatric or behavioral comorbidity preventing participation in a group exercise program
  • History of lower extremity joint arthroplasty
  • Morbid obesity defined as body mass index of 40 or greater
  • Presence of inflammatory arthritic condition
  • Neurologic involvement impacting functional mobility

结局指标

主要结局

Number of participants enrolled in the study

时间窗: 12 weeks

Number of participants enrolled in to the study to determine ability to recruit for the study.

Percentage of enrolled participants at end of study

时间窗: 12 weeks

Number of participants who complete the study divided by the number who enroll in the study to determine retention.

Average number of completed exercise session per-week for the study duration.

时间窗: 12 weeks

Number of clinic session attendance plus the number of self-reported participation in home exercise divided by the study goal of exercising 3 days per week for the 12 week study duration (36 exercise sessions total) yielding a percentage to determine adherence to the exercise intervention.

次要结局

  • Change the Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire score from baseline to after the intervention.(12 weeks)
  • Change in Five-times Sit to Stand (5TSTS) from baseline to after the intervention.(12 weeks)
  • Change in Six-minute Walk Test (6MWT) from baseline to after the intervention.(12 weeks)
  • Change in absolute isometric bilateral quadriceps strength physical performance measure from baseline to after the intervention.(12 weeks)
  • Change in Timed Up and Go (TUG) from baseline to after the intervention.(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Gladin

Senior Physical Therapist

Kaiser Permanente

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