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临床试验/NCT03281668
NCT03281668已完成不适用

Feasibility of High Intensity Interval Training in Knee Osteoarthritis

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Percentage of Enrolled Participants Retained at the End of the Study

研究概览

简要总结

The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based high intensity interval training program (HIIT) to improve physical function in patients with knee osteoarthritis (OA).

详细描述

All participants will be assigned to the single-arm of the study in which all participants will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms ranging from mild to severe. The investigators will determine adherence to and tolerability of HIIT, acceptability, and recruitment and retention rates during the 12 week program. Additional outcomes will include physical function, knee OA symptomatic burden (pain), static standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and body composition.

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
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •between the ages of 40 and 75 years old
  • •body mass index of 18.5-50 kg/m²
  • •exhibits symptomatic knee OA, defined as a diagnosis of knee OA, as identified from University of North Carolina electronic medical records, and current knee symptoms in at least one knee, having a minimum score of 6 out of 20 on the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale.

排除标准

  • •individuals diagnosed with a cardiovascular condition restricting exercise
  • •individuals currently meeting Department of Health and Human Services Guidelines for physical activity (≥ 150 minutes per week
  • •individuals currently doing HIIT
  • •individuals currently participating in physical therapy for knee OA
  • •individuals currently participating in another OA intervention study
  • •received a corticosteroid or hyaluronic acid intra-articular injection in the knee during the previous 3 weeks or scheduled for during the intervention
  • •diagnosis of gout in the knee
  • •diagnosis of rheumatoid arthritis
  • •diagnosis of fibromyalgia
  • •other systemic rheumatic disease
  • •severe dementia or other memory loss
  • •active diagnosis of psychosis or uncontrolled substance abuse disorder
  • •hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
  • •total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior cruciate ligament (ACL) tear in the past 6 months
  • •on a waiting list for total joint replacement
  • •severely impaired hearing or speech
  • •pregnant or planning to become pregnant while enrolled in the study
  • •inability to speak English
  • •serious or terminal illness as indicated by referral to hospice or palliative care
  • •nursing home residence
  • •inability to ride a stationary bike
  • •any other health problems that would prohibit safe participation in the study
  • •EKG results EKG suggesting the individual would not be able to safely participate in this study

研究组 & 干预措施

Intervention

Experimental

Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.

干预措施: High intensity interval training (HIIT) (Behavioral)

结局指标

主要结局

Percentage of Enrolled Participants Retained at the End of the Study

时间窗: Study completion (12 weeks)

Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments

Percent of Potential Participants Screened for the Study Who Are Enrolled

时间窗: Baseline

Number of participants screened and enrolled divided by the total number of participants screened

次要结局

  • Change in Tandem Stand(Baseline, 12 weeks)
  • Change in Number of Chair Stand Repetitions Completed(Baseline, 12 weeks)
  • Change in Stair Climb Test(Baseline, 12 weeks)
  • Change in Timed Up and Go(Baseline, 12 weeks)
  • Change in Feet Together Stand(Baseline, 12 weeks)
  • Change in Semi-tandem Stand(Baseline, 12 weeks)
  • Change in One Leg Stand(Baseline, 12 weeks)
  • Change in Cardiorespiratory Fitness(Baseline, 12 weeks)
  • Change in Whole Body Fat Mass(Baseline, 12 weeks)
  • Change in Lean Body Mass(Baseline, 12 weeks)
  • Change in Visceral Fat(Baseline, 12 weeks)
  • Change in Knee Strength(Baseline, 12 weeks)
  • Average Number of Training Sessions Completed Per Week(Weekly measures for 12 consecutive weeks)
  • Total Number of Training Sessions Completed(12 weeks)
  • Total Number of Training Weeks Completed(12 weeks)
  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks(Baseline,12 weeks)
  • Change in WOMAC Pain Subscale From Baseline to 12 Weeks(Baseline,12 weeks)
  • Change in WOMAC Function Subscale From Baseline to 12 Weeks(Baseline, 12 weeks)
  • Change in 20m Fast Paced Walk Test(Baseline, 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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